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D9319C00001- 1L OC Mono Global RCT

NCT04884360 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2026-03-02

No results posted yet for this study

Summary

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of maintenance olaparib compared with placebo in BRCAwt participants with Stage III to IV high grade serous or endometroid ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who are in complete or partial response following treatment with standard first-line platinum-based chemotherapy.

Conditions

Interventions

DRUG

Olaparib

Olaparib tablets 300 mg oral twice daily

OTHER

Matching placebo

Matching placebo tablets taken orally at a dose of 300 mg twice daily

Sponsors & Collaborators

Principal Investigators

  • Xiaohua Wu · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2026-07-27
Completion
2027-07-27

Countries

  • Chile
  • China
  • Colombia
  • India
  • Peru
  • Russia
  • South Africa
  • Turkey (Türkiye)
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04884360 on ClinicalTrials.gov