Spots Global Cancer Trial Database for Phase I Study of BAY1436032 in IDH1-mutant Advanced Solid Tumors

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Trial Identification

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

Conditions

Solid Tumors

Interventions

BAY1436032

Study Description

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: