Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
3상
진행 중(모집 완료)
NCT01874353
| 대상 질환 | Platinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer, Following Complete or Partial Response to Platinum Based Chemotherapy |
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| 임상 단계 | 3상 |
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| 스폰서 | AstraZeneca |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 327 명 |
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| 중재(약물) | Olaparib 300mg tablets, Placebo to match olaparib 300mg |
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| 시작일 | 2013년 9월 3일 |
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| 완료일 | 2016년 9월 19일 |
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| 결과 공개일 | 2018년 2월 7일 |
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요약
A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.
Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)
Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months. · Months
| Olaparib 300mg Tablets (Global Cohort) | 19.1 Months |
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| Placebo Tablets (Global Cohort) | 5.5 Months |
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| Olaparib 300mg Tablets (China Cohort) | 13.8 Months |
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| Placebo Tablets (China Cohort) | 5.5 Months |
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| p-value | <0.0001 |
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| Hazard Ratio (HR) | 0.30 (95% CI 0.22–0.41) |
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