Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy. - SOLO-1

Study identifier:D0818C00001

ClinicalTrials.gov identifier:NCT01844986

EudraCT identifier:2013-001551-13

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Platinum Based Chemotherapy.

Medical condition

Newly diagnosed

Phase

Phase 3

Healthy volunteers

No

Study drug

Olaparib 300mg tablets

Sex

Female

Actual Enrollment

450

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 26 Aug 2013
Primary Completion Date: 17 May 2018
Estimated Study Completion Date: 29 Aug 2028

Study design

Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Gynecologic Oncology Group (GOG), Myriad Genetics - BRACAnalysis test for FDA Premarket Approval (PMA), Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Inclusion and exclusion criteria