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Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients

NCT01063517 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2023-07-20

Study results available
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Summary

To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy.

Conditions

Interventions

DRUG

olaparib

100mg BID oral tablet continuous

DRUG

paclitaxel

iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle

DRUG

Placebo

100mg BID oral tablet to match olaparib tablet

Sponsors & Collaborators

Principal Investigators

  • Jane Robertson, BSc, MBCHB, MD · AstraZeneca

  • Yung-Jue Bang, MD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-02
Primary Completion
2012-05-11
Completion
2023-06-29

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01063517 on ClinicalTrials.gov