A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy
NCT02670044 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2022-01-03
Summary
The primary objective for this study is to assess the safety and tolerability as well as preliminary efficacy of venetoclax in combination with cobimetinib, and venetoclax in combination with idasanutlin in patients with relapsed or refractory acute myeloid leukemia (R/R) AML who are not eligible for cytotoxic therapy.
Conditions
- Leukemia, Myeloid, Acute
Interventions
- DRUG
-
Cobimetinib
Cobimetinib will be administered orally as per schedule in Arm description.
- DRUG
-
Idasanutlin
Idasanutlin will be administered orally as per schedule in Arm description.
- DRUG
-
Venetoclax will be administered orally as per schedule in Arm description.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-09
- Primary Completion
- 2020-12-10
- Completion
- 2020-12-10
Countries
- United States
- Canada
- France
- Italy
Study Locations
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