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Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.

NCT01924533 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2024-03-22

Study results available
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Summary

This study is a phase III, multi-centre study of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy. Patients will be from China, Japan , Korea and Taiwan.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Yung-Jue Bang, MD · Seoul National University, College of Medicine and Cancer Research Institute, Republic of Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-03
Primary Completion
2016-04-04
Completion
2023-03-27

Countries

  • China
  • Japan
  • South Korea
  • Taiwan

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 NCT01924533 on ClinicalTrials.gov