Olaparib in gBRCA Mutated Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy - POLO

Study identifier:D081FC00001

ClinicalTrials.gov identifier:NCT02184195

EudraCT identifier:2014-001589-85

CTIS identifier:N/A

Study Complete

Official Title

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

Medical condition

germline BRCA1/2 mutations and

Phase

Phase 3

Healthy volunteers

No

Study drug

Olaparib, Placebo

Sex

All

Actual Enrollment

154

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 16 Dec 2014
Primary Completion Date: 15 Jan 2019
Study Completion Date: 27 Jan 2023

Study design

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

Verification:

Verified 01 Jun 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Myriad Genetics - BRCAnalysis test for FDA Premarket Approval (PMA), Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Inclusion and exclusion criteria