NCT02670044

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

A Phase IB Multi-Arm Study With 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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	Venetoclax will be administered orally as per schedule in Arm description.

Timeline

• Start date: 2016-03-09
• Primary completion: 2020-12-10
• Completion: 2020-12-10
• First posted: 2016-02-01
• Last updated: 2022-01-03

Locations

17 sites across 4 countries: United States, Canada, France, Italy