BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)

Bayer

Status and phase: Completed; Phase 1

Conditions: Leukemia, Myeloid, Acute

Treatments: Drug: BAY1436032

Study type: Interventional

Funder types: Industry

Identifiers

NCT03127735

2016-004095-22 (EudraCT Number)

19036

Details and patient eligibility

About

To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1 (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced acute myeloid leukemia (AML)

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with advanced AML that harbors IDH1 mutation
• Patients are relapsed from or refractory to at least 1 previous line of therapy
• Good kidney and liver function
• Male or female patients
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Women must have a negative serum pregnancy test within 7 days prior to the first dose of study drug or be surgically or biologically sterile or postmenopausal

Exclusion criteria

• Previously treated with any prior mIDH1 targeted therapy
• Extramedullary disease only
• History of clinically significant or active cardiac disease
• Active clinically significant infection
• Unresolved chronic toxicity of previous AML treatment
• Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors
• Pregnancy or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

BAY1436032

Experimental group

Description:

Dose escalation: Various doses of study drug will be tested on a small number of patients/dose with the goal of identifying the most appropriate dose(s) for further evaluation in dose expansion. The MTD of the study drug may or may not be identified. It is anticipated that 3-4 patients will be treated at each dose of study drug to be tested and that 15-20 total patients will be treated in this part of the trial. Dose expansion: Up to 2 different doses of study drug will be tested on up to 30 patients/dose with the goal of identifying the most appropriate RP2D for further clinical development. The doses to be evaluated in this part of the trial will be selected based on information obtained during dose escalation.

Treatment:

Drug: BAY1436032