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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 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. The trial reports 20 study locations across 14 states.

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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.

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

FieldValue
Enrollment Target 327 participants
Start Date 2013-09-03
Est. Completion 2025-12-31
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT01874353

The ClinicalTrials.gov registry entry for NCT01874353 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 327 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.