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

PHASE3CompletedINTERVENTIONAL
Enrollment

525

Participants

Timeline

Start Date

September 3, 2013

Primary Completion Date

April 4, 2016

Study Completion Date

March 27, 2023

Conditions
Gastric Cancer
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.

Trial Locations (57)

333

Research Site, Taoyuan District

704

Research Site, Tainan City

6351

Research Site, Seoul

11217

Research Site, Taipei

13620

Research Site, Seongnam-si

42415

Research Site, Daegu

58128

Research Site, Hwasun-gun

83342

Research Site, Kaohsiung Hsien

100021

Research Site, Beijing

100071

Research Site, Beijing

100142

Research Site, Beijing

130000

Research Site, Changchun

150081

Research Site, Harbin

200032

Research Site, Shanghai

200092

Research Site, Shanghai

210002

Research Site, Nanjing

210009

Research Site, Nanjing

225001

Research Site, Yangzhou

233060

Research Site, Bengbu

310003

Research Site, Hangzhou

310016

Research Site, Hangzhou

310022

Research Site, Hangzhou

330006

Research Site, Nanchang

350014

Research Site, Fuzhou

404000

Research Site, Wanzhou

410005

Research Site, Changsha

410011

Research Site, Changsha

410013

Research Site, Changsha

430030

Research Site, Wuhan

450008

Research Site, Zhengzhou

510060

Research Site, Guangzhou

610041

Research Site, Chengdu

610083

Research Site, Chengdu

830000

Research Site, Ürümqi

260-8717

Research Site, Chiba

104-0045

Research Site, Chūōku

811-1395

Research Site, Fukuoka

309-1793

Research Site, Kasama-shi

216-8511

Research Site, Kawasaki-shi

362-0806

Research Site, Kitaadachi-gun

135-8550

Research Site, Kōtoku

791-0280

Research Site, Matsuyama

464-8681

Research Site, Nagoya

003-0804

Research Site, Sapporo

060-8648

Research Site, Sapporo

569-8686

Research Site, Takatsuki-shi

320-0834

Research Site, Utsunomiya

241-8515

Research Site, Yokohama

431-070

Research Site, Anyang-si

561-712

Research Site, Jeonju

02841

Research Site, Seoul

03080

Research Site, Seoul

03722

Research Site, Seoul

06273

Research Site, Seoul

06591

Research Site, Seoul

156-707

Research Site, Seoul

Unknown

Research Site, Taichung

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY