A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
3期
进行中（已停止招募）
NCT03748641
| 适应症 | Castration-Resistant Prostatic Cancer |
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| 分期 | 3期 |
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| 申办方 | Janssen Research & Development, LLC |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 765 人 |
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| 干预（药物） | Niraparib, Abiraterone Acetate, Prednisone, New Formulation of Niraparib and Abiraterone Acetate (AA) |
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| 开始日期 | 2019年1月25日 |
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| 完成日期 | 2021年10月8日 |
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| 结果公布日 | 2023年10月4日 |
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摘要
The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.
Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
Up to 32 months · Months
| Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 16.46 Months |
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| Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 13.70 Months |
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| p-value | 0.0217 |
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| Hazard Ratio (HR) | 0.729 (95% CI 0.556–0.956) |
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Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
Up to 32 months · Months
| Cohort 1 BRCA Subgroup: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 16.56 Months |
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| Cohort 1 BRCA Subgroup: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 10.87 Months |
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| p-value | 0.0014 |
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| Hazard Ratio (HR) | 0.533 (95% CI 0.361–0.789) |
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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。