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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT02670044
Phase
PHASE1
Status
Completed

Conditions

  • Leukemia, Myeloid, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cobimetinib — DRUG
    Cobimetinib will be administered orally as per schedule in Arm description.
  • Idasanutlin — DRUG
    Idasanutlin will be administered orally as per schedule in Arm description.
  • Venetoclax — DRUG
    Venetoclax will be administered orally as per schedule in Arm description.

Study Details

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.

Key Dates

Start date
Mar 9, 2016
Status verified
Dec 2021
Primary completion
Dec 10, 2020
Completion
Dec 10, 2020

Study Design

Enrollment
88 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: Arm A (Venetoclax 400mg + Cobi 40mg)
    Participants received Venetoclax 400mg daily on Days 1-28 of each 28 day treatment cycle and Cobimetinib 40mg daily on Days 1-21 of each 28-day treatment cycle.
  • Experimental: Dose Escalation: Arm A (Venetoclax 600mg + Cobi 40mg)
    Participants received Venetoclax 600mg daily on Days 1-28 of each 28 day treatment cycle and Cobimetinib 40mg daily on Days 1-21 of each 28-day treatment cycle.
  • Experimental: Dose Escalation: Arm A (Venetoclax 800mg + Cobi 40mg)
    Participants received Venetoclax 800mg daily on Days 1-28 of each 28 day treatment cycle and Cobimetinib 40mg daily on Days 1-21 of each 28-day treatment cycle.
  • Experimental: Dose Escalation: Arm A (Venetoclax 400mg + Cobi 60mg)
    Participants received Venetoclax 400mg daily on Days 1-28 of each 28 day treatment cycle and Cobimetinib 60mg daily on Days 1-21 of each 28-day treatment cycle.
  • Experimental: Dose Escalation: Arm B (Venetoclax 400mg + Ida 200mg)
    Participants received Venetoclax 400mg daily on Days 1-28 of each 28 day treatment cycle and Idasanutlin 200mg daily or twice daily on Days 1-5 of each 28 day treatment cycle.
  • Experimental: Dose Escalation: Arm B (Venetoclax 600mg + Ida 150mg)
    Participants received Venetoclax 600mg daily on Days 1-28 of each 28 day treatment cycle and Idasanutlin 150mg daily or twice daily on Days 1-5 of each 28 day treatment cycle.
  • Experimental: Dose Escalation: Arm B (Venetoclax 600mg + Ida 200mg)
    Participants received Venetoclax 600mg daily on Days 1-28 of each 28 day treatment cycle and Idasanutlin 200mg daily or twice daily on Days 1-5 of each 28 day treatment cycle.
  • Experimental: Dose Escalation: Arm B (Venetoclax 400mg + Ida 400mg)
    Participants received Venetoclax 400mg daily on Days 1-28 of each 28 day treatment cycle and Idasanutlin 400mg daily or twice daily on Days 1-5 of each 28 day treatment cycle.
  • Experimental: Dose Optimisation: Arm B (Ven 600mg (Day 1 to 21) + Ida 150mg)
    Participants received Venetoclax 600mg daily on Days 1-21 of each 28 day treatment cycle and Idasanutlin 150mg daily on Days 1-5 of each 28 day treatment cycle.

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: From Cycle 1 Day 1 to Cycle 2 Day 1 for a minimum of 28 days ]

Locations (8)

FacilityCityStateZIPSite coordinators
USC Norris Cancer CenterLos AngelesCalifornia90033-
UC Davis; Comprehensive Cancer CenterSacramentoCalifornia95817-
Univ of Calif, San FranciscoSan FranciscoCalifornia94143-
University of ColoradoAuroraColorado80045-2517-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Weill Cornell Medical CollegeNew YorkNew York10065-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
USC Norris Cancer Center· Los Angeles, CAUC Davis; Comprehensive Cancer Center· Sacramento, CAUniv of Calif, San Francisco· San Francisco, CAUniversity of Colorado· Aurora, CODana Farber Cancer Institute· Boston, MAWeill Cornell Medical College· New York, NY

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