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Brief Title: Phase I Study of BAY1436032 in IDH1-mutant Advanced Solid Tumors
Official Title: An Open-label, Non-randomized, Multicenter Phase I Study to Determine the Maximum Tolerated or Recommended Phase II Dose of Oral Mutant IDH1 Inhibitor BAY1436032 and to Characterize Its Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamic and Anti-tumor Activity in Patients With IDH1-R132X-mutant Advanced Solid Tumors
Study ID: NCT02746081
Brief Summary: The primary objective of this study is: - Determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of BAY 1436032 in patients with isocitrate dehydrogenase-1 (IDH1)-R132X-mutant advanced solid tumors. The secondary objectives of this study are: * Evaluate the pharmacokinetics (PK) of BAY1436032 in patients with IDH1-R132X-mutant advanced solid tumors. * Evaluate the effect of a standard high-fat, high calorie meal on the PK of BAY1436032. * Assess pharmacodynamic (PD) effects and evidence of clinical efficacy associated with BAY1436032 administration in patients with IDH1-R132X-mutant advanced solid tumors.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Los Angeles, California, United States
, Los Angeles, California, United States
, Houston, Texas, United States
, Charlottesville, Virginia, United States
, Copenhagen, , Denmark
, Heidelberg, Baden-Württemberg, Germany
, Tübingen, Baden-Württemberg, Germany
, München, Bayern, Germany
, Frankfurt, Hessen, Germany
, Essen, Nordrhein-Westfalen, Germany
, Nagoya, Aichi, Japan
, Kashiwa-shi, Chiba, Japan
, Chuo-ku, Tokyo, Japan
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR