Spots Global Cancer Trial Database for BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)
Official Title: 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)
Study ID: NCT03127735
Conditions
Interventions
Study Description
Brief 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)
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Montefiore Medical Center, Bronx, New York, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
Mount Sinai Medical Center, New York, 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-Württemberg, Germany
Medizinische Hochschule Hannover (MHH), Hannover, Niedersachsen, Germany
Universitätsklinikum Leipzig AöR, Leipzig, Sachsen, Germany
Universitätsklinikum Charite zu Berlin, Berlin, , Germany
Universitätsklinikum Hamburg Eppendorf (UKE), Hamburg, , Germany
Contact Details
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