Trial Outcomes & Findings for p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246 (NCT NCT02098343)
NCT ID: NCT02098343
Last Updated: 2025-03-17
Results Overview
DLT: Hematological and non-hematological toxicities according to grade/days stated in the protocol.
COMPLETED
PHASE1/PHASE2
247 participants
Until the end of the first treatment cycle, i.e., Day 28
2025-03-17
Participant Flow
Participant milestones
| Measure |
Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD.
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD.
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD.
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase II: Arm A. APR-246 + Carboplatin/PLD.
Experimental
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase II: Arm B. Carboplatin/PLD.
Active Comparator
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
21
|
105
|
106
|
|
Overall Study
COMPLETED
|
9
|
6
|
20
|
105
|
106
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
Baseline characteristics by cohort
| Measure |
Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD.
n=9 Participants
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD.
n=6 Participants
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD.
n=20 Participants
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase II: Arm A. APR-246 + Carboplatin/PLD.
n=105 Participants
Experimental
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase II: Arm B. Carboplatin/PLD.
n=106 Participants
Active Comparator
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
0 Participants
n=7 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
0 Participants
n=5 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
0 Participants
n=4 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
0 Participants
n=21 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
0 Participants
n=8 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
4 Participants
n=7 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
10 Participants
n=5 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
69 Participants
n=4 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
57 Participants
n=21 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
145 Participants
n=8 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
2 Participants
n=7 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
10 Participants
n=5 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
36 Participants
n=4 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
49 Participants
n=21 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
101 Participants
n=8 Participants • 36 patients were enrolled in the Phase Ib study. One patient from the 67.5 mg/kg dose cohort was withdrawn from the study prior to initiating APR-246 treatment due to Investigator's decision.
|
|
Age, Continuous
|
63 years
n=5 Participants
|
62 years
n=7 Participants
|
64.5 years
n=5 Participants
|
61 years
n=4 Participants
|
64 years
n=21 Participants
|
62 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
246 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
3 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
3 Participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
2 Participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
8 Participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
1 Participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
1 Participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
2 Participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
6 Participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
17 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
88 Participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
81 Participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
201 Participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 Participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
13 Participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
22 Participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
35 Participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Region of Enrollment
Netherlands
|
0 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
12 participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
2 participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
14 participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Region of Enrollment
Sweden
|
0 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
1 participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
3 participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
4 participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
1 participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
4 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
10 participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
10 participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
27 participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
17 participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
20 participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
37 participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
5 participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
16 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
33 participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
19 participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
80 participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
12 participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
20 participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
32 participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
1 participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
10 participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
11 participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 participants
n=7 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
0 participants
n=5 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
19 participants
n=4 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
22 participants
n=21 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
41 participants
n=8 Participants • One patient in the 67.5 mg/kg dose cohort (Patient 441-P016) did not meet the eligibility criteria (Exclusion criteria). The eligibility issue for this patient was discovered after the patient had commenced treatment. However, the patient continued the study treatment since it would have been unethical to withdraw the patient from the study.
|
PRIMARY outcome
Timeframe: Until the end of the first treatment cycle, i.e., Day 28DLT: Hematological and non-hematological toxicities according to grade/days stated in the protocol.
Outcome measures
| Measure |
Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD.
n=9 Participants
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD.
n=6 Participants
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD.
n=20 Participants
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase II: Arm A. APR-246 + Carboplatin/PLD.
Experimental
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase II: Arm B. Carboplatin/PLD.
Active Comparator
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
|---|---|---|---|---|---|
|
Phase Ib: Dose-limiting Toxicities (DLT) (See Description) of Combined APR-246 and Carboplatin/PLD Regimen
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Ph Ib = Efficacy Evaluable Ph II = ITT
Phase Ib: Progression-free Survival is calculated from date of enrollment to the date of disease progression or death due to any cause, whichever occurs first. Symptomatic deterioration is not considered PD. For a patient without evidence of disease progression or death, Progression-free survival will be censored at the date of last evaluable tumor assessment. Patients with no evaluable tumor assessments will be censored at the date of first study drug administration. Phase II: Progression-free survival (PFS) based on Blinded Independent Central Review (BICR) is the primary endpoint and is defined as the number of days from the date of randomization to the date of objective disease progression or relapse (according to RECIST v1.1 only) or death due to any cause, whichever occurs first. If neither event occurs, PFS is censored at the date of the last evaluable tumor assessment. Symptomatic deterioration is not considered objective disease progression.
Outcome measures
| Measure |
Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD.
n=7 Participants
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD.
n=4 Participants
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD.
n=19 Participants
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase II: Arm A. APR-246 + Carboplatin/PLD.
n=105 Participants
Experimental
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase II: Arm B. Carboplatin/PLD.
n=106 Participants
Active Comparator
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
|---|---|---|---|---|---|
|
Phase Ib and II: Progression Free Survival (PFS)
|
330 days
Interval 280.0 to 444.0
|
277.5 days
Interval 175.0 to 375.0
|
313 days
Interval 98.0 to 590.0
|
283 days
Interval 240.0 to 314.0
|
295 days
Interval 259.0 to 335.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Phase Ib = Efficacy Evaluable population Phase II = ITT population
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD.
n=7 Participants
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD.
n=4 Participants
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD.
n=19 Participants
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase II: Arm A. APR-246 + Carboplatin/PLD.
n=105 Participants
Experimental
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase II: Arm B. Carboplatin/PLD.
n=106 Participants
Active Comparator
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
|---|---|---|---|---|---|
|
Phase Ib and Phase II: Overall Response Rate (RR)
Complete Response (CR)
|
1 Participants
|
0 Participants
|
2 Participants
|
10 Participants
|
3 Participants
|
|
Phase Ib and Phase II: Overall Response Rate (RR)
Partial response (PR)
|
5 Participants
|
1 Participants
|
9 Participants
|
42 Participants
|
50 Participants
|
|
Phase Ib and Phase II: Overall Response Rate (RR)
Stable Disease (SD)
|
1 Participants
|
3 Participants
|
5 Participants
|
27 Participants
|
37 Participants
|
|
Phase Ib and Phase II: Overall Response Rate (RR)
Progressive Disease (PD)
|
0 Participants
|
0 Participants
|
0 Participants
|
15 Participants
|
5 Participants
|
|
Phase Ib and Phase II: Overall Response Rate (RR)
Not Evaluable (NE)
|
0 Participants
|
0 Participants
|
3 Participants
|
11 Participants
|
11 Participants
|
Adverse Events
Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD.
Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD.
Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD.
Phase II: Arm A. APR-246 + Carboplatin/PLD.
Phase II: Arm B. Carboplatin/PLD.
Serious adverse events
| Measure |
Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD.
n=9 participants at risk
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase:
n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg
|
Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD.
n=6 participants at risk
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase:
n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg
|
Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD.
n=20 participants at risk
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase:
n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg
|
Phase II: Arm A. APR-246 + Carboplatin/PLD.
n=99 participants at risk
Experimental
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase II: Arm B. Carboplatin/PLD.
n=101 participants at risk
Active Comparator
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
30.0%
6/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Device related infection
|
11.1%
1/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
33.3%
2/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Device related sepsis
|
11.1%
1/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
1/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Malaise
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Asthenia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Enterocolitis infectious
|
11.1%
1/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Phlebitis infective
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
Other adverse events
| Measure |
Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD.
n=9 participants at risk
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase:
n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg
|
Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD.
n=6 participants at risk
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase:
n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg
|
Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD.
n=20 participants at risk
Dose escalation of APR-246.
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase:
n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg
|
Phase II: Arm A. APR-246 + Carboplatin/PLD.
n=99 participants at risk
Experimental
APR-246: Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
Phase II: Arm B. Carboplatin/PLD.
n=101 participants at risk
Active Comparator
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
20.0%
4/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
12.1%
12/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.9%
11/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Nausea
|
88.9%
8/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
50.0%
3/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
80.0%
16/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
67.7%
67/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
56.4%
57/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Vomitting
|
44.4%
4/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
33.3%
2/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
80.0%
16/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
42.4%
42/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
22.8%
23/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
3/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
66.7%
4/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
50.0%
10/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
12.1%
12/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.8%
16/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Constipation
|
55.6%
5/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
50.0%
3/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
40.0%
8/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
36.4%
36/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
32.7%
33/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
3/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
30.0%
6/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.2%
16/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.8%
16/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
11.1%
1/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
33.3%
2/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
8.1%
8/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.9%
6/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Asthenia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
19.2%
19/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
21.8%
22/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Fatigue
|
88.9%
8/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
83.3%
5/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
80.0%
16/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
47.5%
47/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
37.6%
38/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Mucosal inflammation
|
44.4%
4/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
25.0%
5/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
20.2%
20/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
21.8%
22/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
30.0%
6/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
13.1%
13/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
9.9%
10/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Device occlusion
|
22.2%
2/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
33.3%
2/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Dizziness
|
66.7%
6/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
50.0%
3/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
75.0%
15/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
42.4%
42/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
5/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Headache
|
77.8%
7/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
50.0%
3/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
30.0%
6/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.2%
16/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.9%
11/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Dysgeusia
|
66.7%
6/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
50.0%
3/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.9%
6/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
8.1%
8/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
20.0%
4/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
11.1%
11/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.9%
6/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
77.8%
7/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
100.0%
6/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
75.0%
15/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
56.6%
56/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
38.6%
39/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
3/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
50.0%
3/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
30.0%
6/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
31.3%
31/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
29.7%
30/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
3/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
33.3%
2/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
30.0%
6/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
23.2%
23/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
13.9%
14/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
3/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
25.0%
5/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
13.1%
13/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
6.9%
7/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
2/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
25.0%
5/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.1%
10/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
5/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
22.2%
2/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
20.0%
4/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
22.2%
2/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Device related infection
|
11.1%
1/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
33.3%
2/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
20.0%
4/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.1%
10/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
17.8%
18/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
44.4%
4/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
45.0%
9/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
19.2%
19/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
17.8%
18/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.1%
1/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
12.1%
12/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.9%
11/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
44.4%
4/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
11.1%
11/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
17.8%
18/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
2/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
20.0%
4/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.1%
10/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
11.9%
12/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.7%
1/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
20.0%
4/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
6.1%
6/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.9%
6/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
2/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.2%
15/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.9%
6/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
16.2%
16/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
12.1%
12/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.9%
11/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
11.1%
11/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
5/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.1%
5/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.9%
6/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.1%
5/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
5/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
5/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
7.1%
7/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Chills
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Infusion site erythema
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
7.1%
7/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
General disorders
Malaise
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.1%
5/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
8.1%
8/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
6.1%
6/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
8.1%
8/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.1%
5/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.1%
5/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
1/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
6.1%
6/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
5/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Lip infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Infusion site infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.1%
5/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
6.1%
6/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.1%
5/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
6.9%
7/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
6.9%
7/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.1%
5/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
9.9%
10/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
7.1%
7/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
5/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.1%
5/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Vascular disorders
Palpitations
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
15.0%
3/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
4.0%
4/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Eye disorders
Photophobia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
3.0%
3/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
10.0%
2/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
1.0%
1/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
9.1%
9/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
7.1%
7/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.99%
1/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
0.00%
0/6 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
5.0%
1/20 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
8.1%
8/99 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
2.0%
2/101 • TEAEs were defined as events occurring on or after Day 1 Cycle 1 up to and including 30 days after last dose, or Cycle 6, up to 7 months.
Ph1b: All dose groups in Ph1b are combined and reported together due to small numbers in escalation phase: n=9 at 35mg/kg n=6 at 50mg/kg n=20 at 67.5mg/kg Ph2: Safety evaluable population is defined as all randomized patients who received any amount of study medication \[APR-246, carboplatin, or PLD\], regardless of duration of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place