Trial Outcomes & Findings for PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (NCT NCT03817320)
NCT ID: NCT03817320
Last Updated: 2025-06-17
Results Overview
The incidence of dose limiting toxicity (DLT) will be measured only during block 1
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
5 weeks
Results posted on
2025-06-17
Participant Flow
Participant milestones
| Measure |
Ixazomib Dose Level 1 (Stratum A)
Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
Ixazomib Dose Level 2 (Stratum A)
Block 1 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
Ixazomib Dose Level -1 (Stratum A)
Block 1 - Patients will be treated on ixazomib at 1.2 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 1.2 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
Ixazomib Dose Level 1 (Stratum B)
Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Leucovorin IV/PO at 5 mg/m\^2 at hour 24 and 30 post-ITs. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
20
|
0
|
1
|
|
Overall Study
COMPLETED
|
3
|
18
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
Baseline characteristics by cohort
| Measure |
Ixazomib Dose Level 1 (Stratum A)
n=3 Participants
Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
Ixazomib Dose Level 2 (Stratum A)
n=20 Participants
Block 1 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
Ixazomib Dose Level 1 (Stratum B)
n=1 Participants
Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Leucovorin IV/PO at 5 mg/m\^2 at hour 24 and 30 post-ITs. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 5 weeksPopulation: Patients with Down Syndrome enrolled in Ixazomib Dose Level 1 (Stratum B) are not eligible for inclusion in the primary DLT or response evaluation. Only the first 6 patients enrolled in Dose Level 2 Stratum A were part of the Phase I portion of this study.
The incidence of dose limiting toxicity (DLT) will be measured only during block 1
Outcome measures
| Measure |
Ixazomib Dose Level 1 (Stratum A)
n=3 Participants
Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
Ixazomib Dose Level 2 (Stratum A)
n=6 Participants
Block 1 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Leucovorin IV/PO at 5 mg/m\^2 at hour 24 and 30 post-ITs. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
|---|---|---|
|
Phase 1: Dose Limiting Toxicity (DLT) During Block 1 of Chemotherapy
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: End of Block 1 treatment, Day 29-35 of treatment, assessed within 35 days from treatment startThe count of participants below represents the number of patients who achieved CR MRD- or CRi MRD- at the end of block 1 treatment and treated at RP2D (recommended phase 2 dose).
Outcome measures
| Measure |
Ixazomib Dose Level 1 (Stratum A)
n=18 Participants
Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
Ixazomib Dose Level 2 (Stratum A)
Block 1 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Leucovorin IV/PO at 5 mg/m\^2 at hour 24 and 30 post-ITs. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
|---|---|---|
|
Phase 2: Response (CR + CR MRD-, and CR + CR MRD- + CRi) After Block 1 Chemotherapy at the RP2D
|
10 Participants
|
—
|
Adverse Events
Ixazomib Dose Level 1 (Stratum A)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Ixazomib Dose Level 2 (Stratum A)
Serious events: 14 serious events
Other events: 20 other events
Deaths: 3 deaths
Ixazomib Dose Level 1 (Stratum B)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixazomib Dose Level 1 (Stratum A)
n=3 participants at risk
Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. . Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
Ixazomib Dose Level 2 (Stratum A)
n=20 participants at risk
Block 1 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
Ixazomib Dose Level 1 (Stratum B)
n=1 participants at risk
Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Leucovorin IV/PO at 5 mg/m\^2 at hour 24 and 30 post-ITs. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abominal Pain
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
35.0%
7/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
35.0%
7/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Nervous system disorders
Edema Cerebral
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
30.0%
6/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
GGT Increased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
20.0%
4/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
35.0%
7/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Typhlitis
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
Other adverse events
| Measure |
Ixazomib Dose Level 1 (Stratum A)
n=3 participants at risk
Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. . Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
Ixazomib Dose Level 2 (Stratum A)
n=20 participants at risk
Block 1 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
Ixazomib Dose Level 1 (Stratum B)
n=1 participants at risk
Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Leucovorin IV/PO at 5 mg/m\^2 at hour 24 and 30 post-ITs. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
30.0%
6/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
30.0%
6/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
3/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
55.0%
11/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Alkaline phosphatase increased
|
100.0%
3/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
25.0%
5/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
80.0%
16/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
35.0%
7/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
3/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
60.0%
12/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
3/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Bleeding labial skin
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
25.0%
5/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
50.0%
10/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Buttock Rash
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Cholesterol high
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
25.0%
5/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Mottled Skin
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
CPK increased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Decreased Respiration
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
35.0%
7/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
20.0%
4/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
General disorders
Edema face
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Enterocolitis infectious
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMATOUS FACIAL RASH
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
25.0%
5/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
3/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
General disorders
Fever
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
35.0%
7/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Eye disorders
Gastritis
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
General disorders
Generalized edema
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
GGT increased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
20.0%
4/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Renal and urinary disorders
Glucosuria
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
20.0%
4/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
3/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
60.0%
12/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
25.0%
5/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
35.0%
7/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
20.0%
4/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
45.0%
9/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
30.0%
6/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
20.0%
4/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
3/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
65.0%
13/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
65.0%
13/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
30.0%
6/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
45.0%
9/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
30.0%
6/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
2/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
90.0%
18/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
60.0%
12/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
General disorders
Increased hunger
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Increased Respiration
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
General disorders
Increased salivation
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
INR increased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
20.0%
4/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Psychiatric disorders
Irritability
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Lactate increased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Lesion on left thumb
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
General disorders
Localized edema
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
85.0%
17/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Blood and lymphatic system disorders
Methemoglobinemia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
25.0%
5/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
General disorders
Multi-organ failure
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
55.0%
11/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Necrotic Bowel
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
75.0%
15/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Oral pain
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
irritated PAC Site
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
25.0%
5/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
General disorders
Pain
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
General disorders
Pale
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
PARAINFLUENZA 1
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Paronychia
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
PARVOVIRUS
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Eye disorders
Periorbital edema
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
PERIRECTAL BREAKDOWN
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
PITYROSPORUM FOLLICULITIS (FOREHEAD)
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
70.0%
14/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
POSITIVE MRSA
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
PRESSURE INJURY
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
20.0%
4/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
RHINOVIRUS
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Eye disorders
SCLERAL HEMORRHAGE
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
30.0%
6/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
15.0%
3/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Endocrine disorders
SYNDROME OF INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Cardiac disorders
TACHYCARDIA
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Vascular disorders
Thrombus
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Thrush
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
Upper respiratory infection
|
66.7%
2/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
10.0%
2/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Vomiting
|
66.7%
2/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
60.0%
12/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Weight gain
|
0.00%
0/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Metabolism and nutrition disorders
Weight loss
|
33.3%
1/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
5.0%
1/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
0.00%
0/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
85.0%
17/20 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
100.0%
1/1 • Adverse events and suspected adverse reactions (CTCAE v5.0 grades 1-5) will be collected and reported from first dose of study therapy through 30 days after the last dose (up to approximately 8 weeks per participant)
No patients enrolled on Dose Level -1 Stratum A. Adverse events were monitored from the first dose of study treatment through 30 days after the last dose for each participant. Response-evaluable Stratum A patients treated at the PO RP2D in phase 1 will be included in the phase 2 analysis as per Section 10.1.2 of the study protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60