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

Phase 1 Completed 88 enrolled Hoffmann-La Roche

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2016-03-09
Primary completion: 2020-12-10
Completion: 2020-12-10

Publications

Daver NG, Dail M, Garcia JS, Jonas BA, Yee KWL, Kelly KR, Vey N, Assouline S, Roboz GJ, Paolini S, Pollyea DA, Tafuri A, Brandwein JM, Pigneux A, Powell BL, Fenaux P, Olin RL, Visani G, Martinelli G, Onishi M, Wang J, Huang W, Green C, Ott MG, Hong WJ, Konopleva MY, Andreeff M. Venetoclax and idasanutlin in relapsed/refractory AML: a nonrandomized, open-label phase 1b trial. Blood. 2023 Mar 16;141(11):1265-1276. doi: 10.1182/blood.2022016362.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cobimetinib	Small molecule	40 mg	Oral
Subject	Cobimetinib	Small molecule	60 mg	Oral
Subject	Idasanutlin	Small molecule	150 mg	Oral
Subject	Idasanutlin	Small molecule	200 mg	Oral
Subject	Idasanutlin	Small molecule	400 mg	Oral
Subject	Venetoclax	Small molecule	400 mg	Oral
Subject	Venetoclax	Small molecule	600 mg	Oral
Subject	Venetoclax	Small molecule	800 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications