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efficacy study of olaparib with paclitaxel versus paclitaxel in gastric cancer patients
Study identifier:D0810C00039
ClinicalTrials.gov identifier:NCT01063517
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomised, double blinded, multicentre phase II study to assess the efficacy of olaparib (AZD2281, KU-0059436) in combination with paclitaxel versus paclitaxel in patients with recurrent or metastatic gastric cancer who progress following first-line therapy
Medical condition
gastric cancer
Phase
Phase 2
Healthy volunteers
No
Study drug
olaparib, paclitaxel, Placebo
Sex
All
Actual Enrollment
124
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 02 Feb 2010
Primary Completion Date: 11 May 2012
Study Completion Date: 29 Jun 2023
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
Seoul, Republic of Korea, 137-701
Location
Research Site
Taegu, Republic of Korea, 705-035
Location
Research Site
Seoul, Republic of Korea, 134-791
Location
Research Site
Jeonnam, Republic of Korea, 519-763
Location
Research Site
Seoul, Republic of Korea, 03722
Location
Research Site
Goyang-si, Republic of Korea, 410-769
Location
Research Site
Seoul, Republic of Korea, 110-744
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Olaparib + paclitaxel | Drug: olaparib 100mg BID oral tablet continuous Drug: paclitaxel iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle Other Name: Taxol |
| Active Comparator: 2 paclitaxel + placebo | Drug: paclitaxel iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle Other Name: Taxol Drug: Placebo 100mg BID oral tablet to match olaparib tablet |
Contacts
Contact
AstraZeneca Clinical Study Information Center
Investigators
Principal Investigator
Jane Robertson
AstraZeneca
