Acute Myeloid Leukemia Clinical Trial

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

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)

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT03127735

Recruitment Status:

Completed

Sponsor:

Bayer

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There are 12 Locations for this study

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Montefiore Medical Center
Bronx New York, 10467, United States
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14263, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States
Ohio State University
Columbus Ohio, 43210, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Universitätsklinikum Heidelberg
Heidelberg Baden-Württemberg, 69120, Germany
Medizinische Hochschule Hannover (MHH)
Hannover Niedersachsen, 30625, Germany
Universitätsklinikum Leipzig AöR
Leipzig Sachsen, , Germany
Universitätsklinikum Charite zu Berlin
Berlin , 12200, Germany
Universitätsklinikum Hamburg Eppendorf (UKE)
Hamburg , 20246, Germany

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT03127735

Recruitment Status:

Completed

Sponsor:


Bayer

How clear is this clinincal trial information?

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