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

Completed · Phase 1

Conditions studied: Leukemia, Myeloid, Acute

In brief

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)

Key facts

Study ID

NCT03127735

Run by

Bayer

People needed

27

Starts

2017-06-14

Expected to finish

2019-03-15

Last updated by the study team

2019-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Universitätsklinikum Leipzig AöR — Leipzig, Saxony, Germany
• Universitätsklinikum Charite zu Berlin — Berlin, Germany
• Universitätsklinikum Hamburg Eppendorf (UKE) — Hamburg, Germany

Full record on ClinicalTrials.gov

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