Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
3期
进行中（已停止招募）
NCT03395197
| 适应症 | mCRPC |
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| 分期 | 3期 |
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| 申办方 | Pfizer |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 1,054 人 |
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| 干预（药物） | Talazoparib with enzalutamide, Placebo with enzalutamide |
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| 开始日期 | 2017年12月18日 |
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| 完成日期 | 2022年10月3日 |
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| 结果公布日 | 2024年1月17日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。