Study to compare the efficacy and safety of olaparib when given in combination with carboplatin and paclitaxel, compared with carboplatin and paclitaxel in patients with advanced ovarian cancer

Study identifier:D0810C00041

ClinicalTrials.gov identifier:NCT01081951

EudraCT identifier:2009-015970-36

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase II Open label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin alone in Patients with Platinum Sensitive Advanced Serous Ovarian Cancer

Medical condition

ovarian cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

olaparib, paclitaxel, carboplatin, Drug: carboplatin

Sex

Female

Actual Enrollment

162

Study type

Interventional

Age

18 Years - 125 Years

Date

Study Start Date: 04 Feb 2010
Primary Completion Date: 10 Oct 2011
Estimated Study Completion Date: 31 Dec 2024

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria