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NCT01874353 · ClinicalTrials.gov registry record · Phase 3
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
A Phase 3 study of Platinum Sensitive and BRCA Mutated, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 327
- Enrollment target
- 20
- Study locations
NCT01874353: Active Phase 3 study of Platinum Sensitive and BRCA Mutated, sponsored by AstraZeneca.
NCT01874353 is a Phase 3 study of Platinum Sensitive and BRCA Mutated that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 327 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01874353, a Phase 3 study of Platinum Sensitive and BRCA Mutated, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 327 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
To determine the efficacy by progression free survival (PFS) (using investigator assessment according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)) of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
Conditions Studied
Interventions
- DRUG Olaparib 300mg tablets
- DRUG Placebo to match olaparib 300mg
Study Locations (20)
Other
- Mercy Hospital for Women - Heidelberg
- The Royal Womens Hospital - Parkville
- Prince of Wales Hospital - Randwick
- U.Z. Gent - Ghent
Maryland
- Greater Baltimore Medical Center - Baltimore
- Johns Hopkins - Baltimore
Massachusetts
- Dana Farber Cancer Institute - Boston
- Massachusetts General Hospital - Boston
New York
- Womens Cancer Care Associates - Albany
- Winthrop Gynecologic Oncology Associates - Mineola
Alabama
- University of Alabama at Birmingham - Birmingham
California
- Palo Alto Foundation Medical Group - San Francisco
Colorado
- University of Colorado - Aurora
Connecticut
- The Hospital of Central Connecticut - New Britain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 327 participants |
| Start Date | 2013-09-03 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
What the registry record for NCT01874353 still lists
NCT01874353 is an interventional study that assigns participants to a tested intervention. The registered 327 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 4 conditions, with Platinum Sensitive appearing as the primary indexed condition, and to 2 interventions - of which Olaparib 300mg tablets is the first listed.
NCT01874353 names 20 study sites across 14 states, led by Other, Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01874353 about?
NCT01874353 is a clinical study titled "Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy". 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 endometrioi...
What is the current status of trial NCT01874353?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 327 participants. The study started on 2013-09-03. Estimated completion is 2025-12-31.
What conditions does trial NCT01874353 study?
This clinical trial studies the following conditions: Platinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer, Following Complete or Partial Response to Platinum Based Chemotherapy.
What interventions are being tested in trial NCT01874353?
The interventions under investigation include: Olaparib 300mg tablets (DRUG), Placebo to match olaparib 300mg (DRUG).
Who is sponsoring clinical trial NCT01874353?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01874353 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01874353's enrollment target sits among peer trials
327 1075th of 2000 higher than 926 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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