Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Olaparib Type: Drug
Name: Paclitaxel Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
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.
Detailed Description
A randomized, double-blinded, multicentre phase III study to access the efficacy and safety of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in Asian patients with advanced gastric cancer (including gastro-oesophageal junction) who have progressed following first line therapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Advanced gastric cancer (including GEJ) that has progressed following first-line therapy.

- Patients must be ≥18 years of age. Age ≥20 if Japanese

- Provision of tumour sample (from either a resection or biopsy).

- At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline and following up visits.

Exclusion Criteria:

- More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy with more than 6 month wash out period) for the treatment of gastric cancer in the advanced setting.

- Any previous treatment with a Polyadenosine 5'-diphosphoribose [poly-(ADP-ribose)] polymerisation (PARP) inhibitor, including olaparib.

- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥5 years.

- Human Epidermalgrowth Factor Receptor-2 (HER2) positive patients.
Locations
Research Site
Beijing, China
Status: Recruiting
Research Site
Bengbu, China
Status: Recruiting
Research Site
Changchun, China
Status: Recruiting
Research Site
Changsha, China
Status: Recruiting
Research Site
Changsha, China
Status: Not yet recruiting
Research Site
Chengdu, China
Status: Recruiting
Research Site
Fuzhou, China
Status: Recruiting
Research Site
Guangzhou, China
Status: Recruiting
Research Site
Hangzhou, China
Status: Recruiting
Research Site
Harbin, China
Status: Recruiting
Research Site
Nanchang, China
Status: Recruiting
Research Site
Nanjing, China
Status: Recruiting
Research Site
Shanghai, China
Status: Recruiting
Research Site
Urumqi, China
Status: Recruiting
Research Site
Wanzhou, China
Status: Recruiting
Research Site
Wuhan, China
Status: Recruiting
Research Site
Xian, China
Status: Withdrawn
Research Site
Yangzhou, China
Status: Recruiting
Research Site
Yinchuan, China
Status: Withdrawn
Research Site
Zhengzhou, China
Status: Recruiting
Research Site
Chiba-shi, Japan
Status: Active, not recruiting
Research Site
Chuo-ku, Japan
Status: Active, not recruiting
Research Site
Fukuoka-shi, Japan
Status: Active, not recruiting
Research Site
Kasama-shi, Japan
Status: Active, not recruiting
Research Site
Kashiwa-shi, Japan
Status: Withdrawn
Research Site
Kawasaki-shi, Japan
Status: Active, not recruiting
Research Site
Kitaadachi-gun, Japan
Status: Active, not recruiting
Research Site
Koto-ku, Japan
Status: Active, not recruiting
Research Site
Matsuyama-shi, Japan
Status: Active, not recruiting
Research Site
Nagoya-shi, Japan
Status: Active, not recruiting
Research Site
Sapporo-shi, Japan
Status: Active, not recruiting
Research Site
Takatsuki-shi, Japan
Status: Active, not recruiting
Research Site
Utsunomiya-shi, Japan
Status: Active, not recruiting
Research Site
Yokohama-shi, Japan
Status: Active, not recruiting
Research Site
Anyang-si, Korea, Republic of
Status: Active, not recruiting
Research Site
Daegu, Korea, Republic of
Status: Active, not recruiting
Research Site
Hwasun-gun, Korea, Republic of
Status: Active, not recruiting
Research Site
Jeonju-si, Korea, Republic of
Status: Active, not recruiting
Research Site
Seongnam-si, Korea, Republic of
Status: Active, not recruiting
Research Site
Seoul, Korea, Republic of
Status: Active, not recruiting
Research Site
Kaohsiung Hsien, Taiwan
Status: Recruiting
Research Site
Taichung, Taiwan
Status: Recruiting
Research Site
Tainan, Taiwan
Status: Recruiting
Research Site
Taipei, Taiwan
Status: Recruiting
Research Site
Tao-Yuan, Taiwan
Status: Recruiting
Start Date
September 2013
Completion Date
December 2017
Sponsors
AstraZeneca
Source
AstraZeneca
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page