This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.
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Number of Participants With Objective Response
Timeframe: From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Number of Participants With Best Overall Response
Timeframe: From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Progression-Free Survival (PFS)
Timeframe: Baseline, until PD or death due to any cause (maximum duration:1071 days for Part 1; 834 days for Part 2)
Duration of Response
Timeframe: Baseline until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Number of Participants With Stable Disease
Timeframe: Baseline, until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
Part 1: Maximum Tolerated Dose (MTD)
Timeframe: Cycle 1 (Day 1 up to Day 42)
Part 1: Recommended Part 2 Dose of Talazoparib
Timeframe: Baseline up to Cycle 50 (each cycle 28 days)