A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Overview
- Phase
- Phase 1
- Intervention
- CC-96191
- Conditions
- Leukemia, Myeloid
- Sponsor
- Celgene
- Enrollment
- 45
- Locations
- 14
- Primary Endpoint
- Dose limiting toxicities (DLTs)
- Status
- Terminated
- Last Updated
- 11 months ago
Overview
Brief Summary
This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML).
The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy.
The expansion (Part B), will further evaluate the safety and efficacy of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
CC-96191
CC-96191 will be administered intravenously on a 28-day Cycle
Intervention: CC-96191
Outcomes
Primary Outcomes
Dose limiting toxicities (DLTs)
Time Frame: Up to 42 days after the first dose
Are defined as toxicities that meet the protocol-specified criteria occurring within the DLT assessment window (Cycle 1, Days 1 to at least 28 and up to 42 days) that cannot be attributed to a clearly identifiable cause such as underlying illness, disease progression, other concurrent illness, or concomitant medication.
Maximum tolerated dose (MTD)
Time Frame: Up to 35 days after the last dose
Is defined as the highest dose at which less than 33% of the population treated with CC-96191 experience a dose limiting toxicity (DLT) in the first cycle.
Adverse Events (AEs)
Time Frame: Up to 35 days after the last dose
Type, frequency, seriousness, severity and relationship of AEs to CC-96191
Secondary Outcomes
- Pharmacokinetics - t1/2(Up to 35 days after last dose)
- Complete remission rate (CRR)(Up to approximately 2 years)
- Objective response rate (ORR)(Up to approximately 2 years)
- Progression-free survival (PFS)(Up to approximately 2 years)
- Pharmacokinetics - CL(Up to 35 days after last dose)
- Time to remission(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Duration of remission(Up to approximately 2 years)
- Pharmacokinetics - Vss(Up to 35 days after last dose)
- Presence of anti-drug antibodies (ADA)(Up to 35 days after last dose)
- Pharmacokinetics - Cmax(Up to 35 days after last dose)
- Pharmacokinetics - AUC(Up to 35 days after last dose)
- Pharmacokinetics - tmax(Up to 35 days after last dose)
- Frequency of anti-drug antibodies (ADA)(Up to 35 days after last dose)