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Platine, Avastin and OLAparib in 1st Line

NCT02477644 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 806

Last updated 2022-08-02

No results posted yet for this study

Summary

Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.

Conditions

Interventions

DRUG

Olaparib

Tablets, per os, 300 mg twice daily;

DRUG

Placebo

Tablets, per os, 300 mg twice daily.

Sponsors & Collaborators

  • Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany

    collaborator OTHER

  • Arbeitsgemeinschaft Gynaekologische Onkologie Austria

    collaborator OTHER

  • Grupo Español de Investigación en Cáncer de Ovario

    collaborator OTHER

  • Belgian Gynaecological Oncology Group

    collaborator OTHER

  • Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies

    collaborator UNKNOWN

  • Mario Negri Gynecologic Oncology group (MaNGO)

    collaborator OTHER

  • Nordic Society of Gynaecological Oncology - Clinical Trials Unit

    collaborator OTHER

  • Gynecologic Oncology Trial & Investigation Consortium

    collaborator NETWORK

  • Arcagy Research

    lead OTHER

Principal Investigators

  • Isabelle RAY COQUARD, MD, PhD · Centre Leon Berard

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-06
Primary Completion
2019-03-22
Completion
2022-03-22

Countries

  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Japan
  • Monaco
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02477644 on ClinicalTrials.gov