Efficacy and safety study of olaparib in combination with paclitaxel to treat advanced gastric cancer.
Study identifier:D081BC00004
ClinicalTrials.gov identifier:NCT01924533
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomized, double-blinded, placebo controlled, multicentre phase III study to assess the efficacy and safety of olaparib (AZD2281) in combination with paclitaxel, compared to placebo in combination with paclitaxel, in Asian patients with advanced gastric cancer (including the gastro-oesophageal junction) who have progressed following first line therapy
Medical condition
gastric cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Olaparib, Paclitaxel, Placebo
Sex
All
Actual Enrollment
525
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 03 Sept 2013
Primary Completion Date: 04 Apr 2016
Study Completion Date: 27 Mar 2023
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Olaparib+ paclitaxel olaparib + paclitaxel | Drug: Olaparib Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily. Drug: Paclitaxel IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule. |
| Placebo Comparator: Placebo+paclitaxel placebo+ paclitaxel | Drug: Paclitaxel IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule. Drug: Placebo Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily. |
Contacts
Investigators
Principal Investigator
Yung-Jue Bang
Seoul National University, College of Medicine and Cancer Research Institute, Republic of Korea
