Trial Outcomes & Findings for IIT CTI Bendamustine, Rituximab, Pixantrone in Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma (NCT NCT01491841)
NCT ID: NCT01491841
Last Updated: 2020-03-04
Results Overview
Dose-limiting toxicity (DLT) assessments were performed weekly during cycles 1 and 2. A DLT was defined as any grade 3 non-hematologic toxicity that lasted longer than 48 hours, despite proper supportive care, any grade 4 non-hematologic toxicity, or any grade 3 or 4 hematologic toxicity lasting longer than 7 days. Alopecia and febrile neutropenia were not considered DLTs. Any NCI CTC (National Cancer Institute Common Terminology Criteria) v4.03 grade 5 (death) toxicity was considered a DLT. Dose Limiting Toxicities were used as the assessment criteria to determine the Maximum Tolerated Dose (MTD). MTD is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
4 years
Results posted on
2020-03-04
Participant Flow
The study opened November 1, 2011 and closed to accrual September 22, 2016. Subjects were recruited through the Hematology Clinic at Duke University Medical Center.
Participant milestones
| Measure |
Bendamustine + Rituximab + Pixantrone
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD (maximum tolerated dose); to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Bendamustine + Rituximab + Pixantrone
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD (maximum tolerated dose); to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
|---|---|
|
Overall Study
Screen Failure
|
10
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
IIT CTI Bendamustine, Rituximab, Pixantrone in Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Bendamustine + Rituximab + Pixantrone
n=33 Participants
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: Over the course of 4 years, dose escalation was performed in 3 cohorts. Cohort 1 (Phase 1: Pixantrone, 55mg/m\^2) enrolled 7 people; Cohort 2 (Phase 1: Pixantrone, 85mg/m\^2) enrolled 7 people; Cohort 3 (Phase 1: Pixantrone, 115 mg/m\^2) enrolled 7 people.
Dose-limiting toxicity (DLT) assessments were performed weekly during cycles 1 and 2. A DLT was defined as any grade 3 non-hematologic toxicity that lasted longer than 48 hours, despite proper supportive care, any grade 4 non-hematologic toxicity, or any grade 3 or 4 hematologic toxicity lasting longer than 7 days. Alopecia and febrile neutropenia were not considered DLTs. Any NCI CTC (National Cancer Institute Common Terminology Criteria) v4.03 grade 5 (death) toxicity was considered a DLT. Dose Limiting Toxicities were used as the assessment criteria to determine the Maximum Tolerated Dose (MTD). MTD is presented.
Outcome measures
| Measure |
Bendamustine + Rituximab + Pixantrone + Pegfilgrastim
n=21 Participants
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
Pixantrone, 85mg/m^2
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
Pixantrone, 115mg/m^2
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
|---|---|---|---|
|
Maximum Tolerated Dose
|
115 milligrams per meter squared
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 220 daysPopulation: Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
Partial response and complete response evaluated using a modified version of the revised response criteria for malignant lymphoma by Cheson et al Complete Response (CR) • Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present prior to therapy. Complete Response Unconfirmed (CRu) meets the CR criteria, but with one or more of the following: * A residual node \> 1.5 cm in greatest transverse diameter that has regressed \>75% in the sum of the product of the diameters (SPD). Individual nodes that were previously confluent must have regressed \>75% in their SPD compared with the size of the original mass. * Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia by immunohistochemistry or flow cytometry). Partial Response (PR) • A decrease of ≥ 50% in the SPD of up to six of the largest dominant nodes or nodal masses.
Outcome measures
| Measure |
Bendamustine + Rituximab + Pixantrone + Pegfilgrastim
n=4 Participants
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
Pixantrone, 85mg/m^2
n=3 Participants
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
Pixantrone, 115mg/m^2
n=7 Participants
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
|---|---|---|---|
|
Overall Response
|
2 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From day 1 of treatment to disease progression, death or 5 years, whichever comes firstPopulation: Groups combined to include all subjects who completed the study. This analysis was originally planned for Phase 2; there was no intent to compare dose levels in Phase 1 because there would be insufficient power to make meaningful comparisons.
Outcome measures
| Measure |
Bendamustine + Rituximab + Pixantrone + Pegfilgrastim
n=22 Participants
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
Pixantrone, 85mg/m^2
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
Pixantrone, 115mg/m^2
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
|---|---|---|---|
|
Progression Free Survival
|
3.9 months
Interval 1.3 to 6.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days post last dose of study drugPopulation: Phase 1 subjects who received study drugs.
Dose limiting toxicities plus % of patients with a clinically significant change in left ventricular ejection fraction.
Outcome measures
| Measure |
Bendamustine + Rituximab + Pixantrone + Pegfilgrastim
n=7 Participants
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
Pixantrone, 85mg/m^2
n=7 Participants
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
Pixantrone, 115mg/m^2
n=7 Participants
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
|---|---|---|---|
|
Toxicity
Dose-Limiting Toxicity
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Toxicity
Left Ventricular Ejection Fraction
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity
Other Adverse Events
|
6 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: from day 1 of treatment to deathPopulation: Groups combined to include all subjects who completed the study. This analysis was originally planned for Phase 2; there was no intent to compare dose levels in Phase 1 because there would be insufficient power to make meaningful comparisons.
Outcome measures
| Measure |
Bendamustine + Rituximab + Pixantrone + Pegfilgrastim
n=22 Participants
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
Pixantrone, 85mg/m^2
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
Pixantrone, 115mg/m^2
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
|
|---|---|---|---|
|
Overall Survival
|
7.9 months
Interval 4.2 to 15.4
|
—
|
—
|
Adverse Events
Pixantrone, 55mg/m^2
Serious events: 3 serious events
Other events: 7 other events
Deaths: 6 deaths
Pixantrone, 85mg/m^2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 7 deaths
Pixantrone, 115mg/m^2
Serious events: 2 serious events
Other events: 8 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Pixantrone, 55mg/m^2
n=7 participants at risk
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 55mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
|
Pixantrone, 85mg/m^2
n=7 participants at risk
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
|
Pixantrone, 115mg/m^2
n=8 participants at risk
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
Other adverse events
| Measure |
Pixantrone, 55mg/m^2
n=7 participants at risk
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 55mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
|
Pixantrone, 85mg/m^2
n=7 participants at risk
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
|
Pixantrone, 115mg/m^2
n=8 participants at risk
Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
2/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
62.5%
5/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
25.0%
2/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
50.0%
4/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
General disorders
Pain
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Eye disorders
Dry eye
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Eye disorders
Watering eyes
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Gastrointestinal disorders
Bloating
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
37.5%
3/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
25.0%
2/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
37.5%
3/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
50.0%
4/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
General disorders
Edema limbs
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
General disorders
Fatigue
|
71.4%
5/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
28.6%
2/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
75.0%
6/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
General disorders
Fever
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
General disorders
Gait disturbance
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
General disorders
Injection site reaction
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
General disorders
Localized edema
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
General disorders
Malaise
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Infections and infestations
Gum infection
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
25.0%
2/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
37.5%
3/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Investigations
Creatinine increased
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
50.0%
4/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Investigations
Platelet count decreased
|
28.6%
2/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
62.5%
5/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Investigations
Urine output decreased
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Investigations
Weight loss
|
28.6%
2/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Investigations
White blood cell decreased
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
37.5%
3/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Metabolism and nutrition disorders
Anorexia
|
57.1%
4/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
28.6%
2/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
28.6%
2/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
25.0%
2/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
37.5%
3/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
25.0%
2/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Musculoskeletal and connective tissue disorders
Abdominal soft tissue necrosis
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
62.5%
5/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
42.9%
3/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
25.0%
2/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
25.0%
2/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
50.0%
4/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
25.0%
2/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Renal and urinary disorders
Urinary retention
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
37.5%
3/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.9%
3/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
37.5%
3/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
12.5%
1/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
0.00%
0/7 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
25.0%
2/8 • Up to 220 days
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place