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

Bayer27 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia, Myeloid, Acute

Interventions

BAY1436032DRUG

BAY1436032 administered continuously as a single agent dosed twice a day orally on Days 1 to 28 of a 28-day cycle. Patients may continue treatment with BAY1436032 until disease progression, development of other unacceptable toxicity or Investigator discretion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

Maximum tolerated dose (MTD) or RP2D of BAY1436032

If the MTD is not reached during dose escalation, the primary variable will be the recommended phase 2 dose (RP2D) of BAY1436032

Time frame: Within first 4 weeks of first dose

Number of participants with Adverse Events as a Measure of

As a measure of safety and tolerability

Time frame: Up to 12 weeks

Secondary Outcomes

Objective efficacy response

Response assessment for AML in this study will be based on the modified Cheson criteria. The following categories are used to capture the investigator's AML response evaluation: * Complete remission (CR) * Morphologic CR with CRh (morphologic CR with incomplete hematological recovery) and the response category CRp (morphologic CR with incomplete platelet recovery) * Partial remission (PR) * Response categories for morphologic leukemia-free state (MLFS), stable disease and progressive disease * Progressive disease

Time frame: Up to 12 weeks

Duration of response

Efficacy data

Time frame: Up to 12 weeks

Event-free survival (EFS)

EFS defined as time from start of treatment to treatment failure, relapse, or death due to any cause.

Time frame: Up to 12 weeks

Change of 2 hydroxyglutarate (2-HG) level obtained at baseline and post-baseline

Assess pharmacodynamic (PD) effects and evidence of clinical efficacy associated with BAY 1436032 administration in patients. Change from baseline and percent change from baseline will be calculated.

Time frame: Up to 12 weeks

Data from ClinicalTrials.gov

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