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BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

An Open-label, Non-randomized, Multicenter Phase I Study 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)

NCT03127735•Bayer

View on ClinicalTrials.gov

Summary

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)

Eligibility

Age

18 - No limit years

Sex

ALL

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

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

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Medizinische Hochschule Hannover (MHH)

Hanover, Lower Saxony, Germany

Key Dates

Start Date

June 14, 2017

Primary Completion Date

December 6, 2018

Completion Date

March 15, 2019

Last Updated

May 14, 2019

Enrollment

ACTUAL participants

Conditions

Leukemia, Myeloid, Acute

Interventions

BAY1436032

DRUG

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT06852222

Leukemia, Myeloid, Acute

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RECRUITING

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

NCT06580106

Leukemia, Myeloid, Acute

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RECRUITINGPHASE1

A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy

DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia

Interest of Light Therapy in Hematology - The PHOTO-TREAT Study