Trial Outcomes & Findings for Dose-Escalation Trial of Carfilzomib With and Without Romidepsin in Cutaneous T-Cell Lymphoma (NCT NCT01738594)
NCT ID: NCT01738594
Last Updated: 2019-08-29
Results Overview
To determine the maximum tolerated dose (MTD) by assessing the adverse events experienced by patients of both carfilzomib alone and when taken with romidepsin for dose limiting toxicities (DLT) on days 1 and 15 of the first 28 days of treatment. Toxicities will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. DLT is defined as any of the following: Grade ≥ 2 neuropathy with pain Grade ≥ 3 non-hematologic toxicity Grade ≥ 3 nausea, vomiting, or diarrhea not controlled Grade ≥ 4 fatigue persisting for \> 7 days Grade 4 neutropenia (ANC \< 500/mm3) occurring for \>7 days Febrile neutropenia \[ANC \< 1000/mm3 with fever Grade ≥ 3 thrombocytopenia persisting for \> 7 days Grade ≥ 3 thrombocytopenia associated with bleeding Any toxicity requiring a dose reduction within Cycle 1 Inability to receive Cycle 2, Day 1 dose due to drug related toxicity persisting from Cycle 1 or drug-related toxicity newly encountered on Cycle 2, Day 1
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
During the first 28 days (1 cycle=28 days) of treatment.
Results posted on
2019-08-29
Participant Flow
The study opened for accrual on December 19, 2012 with the first patient being enrolled on March 22, 2013 and an accrual goal of up to 48 patients. The study was designed as a dose escalation with 3+3 cohorts and two arms. The study was closed to further accrual of patients on September 13, 2016 due to slow accrual.
Participant milestones
| Measure |
Arm A, Cohort -1 (Carfilzomib)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 27 mg/m2.
carfilzomib: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm A, Cohort 1 (Carfilzomib)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.
carfilzomib: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm A, Cohort 2 (Carfilzomib)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 45 mg/m2.
carfilzomib: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm A, Cohort 3 (Carfilzomib)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 56 mg/m2.
carfilzomib: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort -1 (Carfilzomib + Romidepsin)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 27 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort 1 (Carfilzomib + Romidepsin
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort 2 (Carfilzomib + Romidepsin)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 45 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort 3 (Carfilzomib + Romidepsin)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 56 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|---|---|---|---|---|
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Registration and Treatment Start
STARTED
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0
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3
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0
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0
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1
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3
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Registration and Treatment Start
Registered to Study
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0
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3
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0
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0
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1
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3
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0
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0
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Registration and Treatment Start
Treatment Started
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0
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2
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0
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0
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1
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3
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0
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0
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Registration and Treatment Start
COMPLETED
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0
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2
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0
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0
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1
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3
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0
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0
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Registration and Treatment Start
NOT COMPLETED
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0
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1
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0
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0
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0
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0
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0
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0
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Completed 2 Cycles/Reached 1st Response
STARTED
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0
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2
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0
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0
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1
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3
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0
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0
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Completed 2 Cycles/Reached 1st Response
COMPLETED
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0
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2
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0
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0
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1
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2
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0
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0
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Completed 2 Cycles/Reached 1st Response
NOT COMPLETED
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0
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0
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0
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0
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0
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1
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0
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0
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Completed 4 Cycles of Treatment
STARTED
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0
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2
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0
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0
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1
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2
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0
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0
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Completed 4 Cycles of Treatment
COMPLETED
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0
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0
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0
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0
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1
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1
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0
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0
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Completed 4 Cycles of Treatment
NOT COMPLETED
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0
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2
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0
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0
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0
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1
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0
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0
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Went on to Continue Treatment Cycle 5
STARTED
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0
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0
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0
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0
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1
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1
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0
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0
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Went on to Continue Treatment Cycle 5
COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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Went on to Continue Treatment Cycle 5
NOT COMPLETED
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0
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0
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0
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0
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1
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1
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0
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0
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Follow up for 1 Year
STARTED
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0
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2
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0
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0
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1
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3
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0
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0
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Follow up for 1 Year
COMPLETED
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0
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2
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0
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0
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1
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0
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0
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0
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Follow up for 1 Year
NOT COMPLETED
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0
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0
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0
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0
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0
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3
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0
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0
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Reasons for withdrawal
| Measure |
Arm A, Cohort -1 (Carfilzomib)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 27 mg/m2.
carfilzomib: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm A, Cohort 1 (Carfilzomib)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.
carfilzomib: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm A, Cohort 2 (Carfilzomib)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 45 mg/m2.
carfilzomib: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm A, Cohort 3 (Carfilzomib)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 56 mg/m2.
carfilzomib: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort -1 (Carfilzomib + Romidepsin)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 27 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort 1 (Carfilzomib + Romidepsin
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort 2 (Carfilzomib + Romidepsin)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 45 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort 3 (Carfilzomib + Romidepsin)
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 56 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|---|---|---|---|---|
|
Registration and Treatment Start
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Completed 2 Cycles/Reached 1st Response
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Completed 4 Cycles of Treatment
Progressive disease
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Completed 4 Cycles of Treatment
No response/patient benefit
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Went on to Continue Treatment Cycle 5
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Went on to Continue Treatment Cycle 5
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Follow up for 1 Year
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Follow up for 1 Year
Other
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Dose-Escalation Trial of Carfilzomib With and Without Romidepsin in Cutaneous T-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A, Cohort 1 (Carfilzomib)
n=3 Participants
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.
carfilzomib: Given IV laboratory biomarker analysis: Correlative studies
|
Arm B Cohort 1 (Carfilzomib + Romidepsin)
n=1 Participants
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle. carfilzomib: Given IV romidepsin: Given IV laboratory biomarker analysis: Correlative studies
|
Arm B Cohort 2 (Carfilzomib + Romidepsin)
n=3 Participants
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 45 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle. carfilzomib: Given IV romidepsin: Given IV laboratory biomarker analysis: Correlative studies
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=39 Participants
|
1 participants
n=41 Participants
|
3 participants
n=35 Participants
|
7 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: During the first 28 days (1 cycle=28 days) of treatment.Population: Study terminated early due to slow accrual and not all cohorts enrolled patients. Only number of patients that experienced DLTs are shown below for arms and cohorts that enrolled as data could not be collected regarding MTD
To determine the maximum tolerated dose (MTD) by assessing the adverse events experienced by patients of both carfilzomib alone and when taken with romidepsin for dose limiting toxicities (DLT) on days 1 and 15 of the first 28 days of treatment. Toxicities will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. DLT is defined as any of the following: Grade ≥ 2 neuropathy with pain Grade ≥ 3 non-hematologic toxicity Grade ≥ 3 nausea, vomiting, or diarrhea not controlled Grade ≥ 4 fatigue persisting for \> 7 days Grade 4 neutropenia (ANC \< 500/mm3) occurring for \>7 days Febrile neutropenia \[ANC \< 1000/mm3 with fever Grade ≥ 3 thrombocytopenia persisting for \> 7 days Grade ≥ 3 thrombocytopenia associated with bleeding Any toxicity requiring a dose reduction within Cycle 1 Inability to receive Cycle 2, Day 1 dose due to drug related toxicity persisting from Cycle 1 or drug-related toxicity newly encountered on Cycle 2, Day 1
Outcome measures
| Measure |
Arm A, Cohort 1 (Carfilzomib)
n=2 Participants
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.
carfilzomib: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort -1 (Carfilzomib + Romidepsin)
n=1 Participants
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 27 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort 1 (Carfilzomib + Romidepsin
n=3 Participants
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Number of Patients With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and every 56 days (2 cycles) while on treatment and up to 4 cyclesPopulation: Data was not collected for this outcome measure due to study terminating early due to slow accrual.
Overall Response Rate (ORR) is defined as number of patients who's best response is complete response or partial response. Response will be categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The overall response rate of the study treatment will be evaluated based on skin biopsy, CT scans, and blood tests at the beginning of the study as well as every 56 days (2 cycles).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and every 56 days (2 cylces) until disease progressionPopulation: Data was not collected for this outcome measure due to the study terminating early due to slow accrual.
Duration of response will be defined as the time from the point at which response is achieved until the point of disease progression. The duration of response of the study treatment will be evaluated based on skin biopsy, CT scans, and blood tests at the beginning of the study as well as every 56 days (2 cycles).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and every 56 days (2 cycles) until disease progression or toxicity call for discontinuation of treatmentPopulation: Data was not collected for this outcome measure due to the study terminating early due to slow accrual.
The time to progression (TTP) will be measured as the time from the first dose of study therapy until the point at which disease is determined to have progressed or patients discontinue therapy for toxicity. To measure time to progression, the study treatment will be evaluated based on skin biopsy, CT scans, and blood tests at the beginning of the study as well as every 56 days (2 cycles).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood is collected before & after carfilzomib dosing during cycle 1 (days 1, 2, & 8) & cycle 2 (day 1) & Tumor tissue samples obtained at baseline, 1-4 hours post-first dose of carfilzomib (cycle 1 day 1) & 1-4 hours post-carfilzomib on cycle 1 day 8Population: Data was not collected for this outcome measure due to the study terminating early due to slow accrual.
Proteasome inhibition will be measured by evaluating proteasome activity in blood and tumor tissue biopsy specimens while on treatment of carfilzomib alone as well as carfilzomib with romidepsin.
Outcome measures
Outcome data not reported
Adverse Events
Arm A, Cohort 1 (Carfilzomib)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm B Cohort -1 (Carfilzomib + Romidepsin)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm B Cohort 1 (Carfilzomib + Romidepsin
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A, Cohort 1 (Carfilzomib)
n=2 participants at risk
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.
carfilzomib: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort -1 (Carfilzomib + Romidepsin)
n=1 participants at risk
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 27 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort 1 (Carfilzomib + Romidepsin
n=3 participants at risk
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
Other adverse events
| Measure |
Arm A, Cohort 1 (Carfilzomib)
n=2 participants at risk
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.
carfilzomib: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort -1 (Carfilzomib + Romidepsin)
n=1 participants at risk
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 27 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
Arm B Cohort 1 (Carfilzomib + Romidepsin
n=3 participants at risk
Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle.
Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2.
and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle.
carfilzomib: Given IV
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
100.0%
1/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
66.7%
2/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Cardiac disorders
palpitations
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
100.0%
1/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
General disorders
Chills
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
General disorders
Edema limbs
|
100.0%
2/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
General disorders
Edema trunk
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
General disorders
Fatigue
|
100.0%
2/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
100.0%
1/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
General disorders
Fever
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
100.0%
1/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
66.7%
2/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Investigations
Blood bilirubin increased
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Investigations
Creatinine increased
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
66.7%
2/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Investigations
Weight loss
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Investigations
White blood cell decreased
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
2/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Metabolism and nutrition disorders
Hypernatremia
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Metabolism and nutrition disorders
Bronchopulmonary hemorrhage
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
66.7%
2/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/2 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
0.00%
0/1 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
33.3%
1/3 • Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place