Platine, Avastin and OLAparib in 1st Line

Sponsor
Arcagy Research
Study ID
NCT02477644
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Tablets, per os, 300 mg twice daily;
  • Placebo — DRUG
    Tablets, per os, 300 mg twice daily.

Study Details

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.

Key Dates

Start date
May 6, 2015
Status verified
Aug 2022
Primary completion
Mar 22, 2019
Completion
Mar 22, 2022

Study Design

Enrollment
806 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib
    Tablets per os 300 mg
  • Placebo Comparator: Placebo
    Tablets per os 300 mg

Primary Outcome Measure

Efficacy by progression free survival (PFS1) [ Time Frame: phase up to a total of 15 months ]

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