Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
第3相
実施中（募集終了）
NCT03395197
| 対象疾患 | mCRPC |
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| 相 | 第3相 |
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| スポンサー | Pfizer |
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| ステータス | 実施中（募集終了） |
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| 参加者数 | 1,054 名 |
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| 介入（薬剤） | Talazoparib with enzalutamide, Placebo with enzalutamide |
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| 開始日 | 2017年12月18日 |
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| 完了日 | 2022年10月3日 |
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| 結果公開日 | 2024年1月17日 |
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概要
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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BENITIONS で見る
ClinicalTrials.gov の原文を見る
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