Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
Phase 3
Active, not recruiting
NCT03395197
| Condition | mCRPC |
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| Phase | Phase 3 |
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| Sponsor | Pfizer |
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| Status | Active, not recruiting |
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| Enrollment | 1,054 participants |
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| Interventions | Talazoparib with enzalutamide, Placebo with enzalutamide |
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| Start date | Dec 18, 2017 |
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| Completion date | Oct 3, 2022 |
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| Results posted | Jan 17, 2024 |
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Summary
This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
Post dose on Day 1 up to Day 66 in Part 1 · Participants
| Part 1: Talazoparib 1 mg QD+Enzalutamide | 13 Participants |
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| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 6 Participants |
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| Part 1: Talazoparib 1 mg QD+Enzalutamide | 0 Participants |
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| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 0 Participants |
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| Part 1: Talazoparib 1 mg QD+Enzalutamide | 1 Participants |
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| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 0 Participants |
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Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
Post dose on Day 1 up to Day 66 in Part 1 · Participants
| Part 1: Talazoparib 1 mg QD+Enzalutamide | 2 Participants |
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| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 0 Participants |
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| Part 1: Talazoparib 1 mg QD+Enzalutamide | 6 Participants |
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| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 1 Participants |
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| Part 1: Talazoparib 1 mg QD+Enzalutamide | 1 Participants |
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| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 0 Participants |
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Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks) · Participants
| Part 1: Talazoparib 1 mg QD+Enzalutamide | 13 Participants |
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| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 6 Participants |
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| Part 1: Talazoparib 1 mg QD+Enzalutamide | 0 Participants |
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| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 0 Participants |
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| Part 1: Talazoparib 1 mg QD+Enzalutamide | 6 Participants |
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| Part 1: Talazoparib 0.5 mg QD+Enzalutamide | 3 Participants |
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Open in BENITIONS
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