Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
Launched by ASTRAZENECA · Aug 14, 2013
Trial Information
Current as of July 05, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility 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.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, , China
Taichung, , Taiwan
Tainan, , Taiwan
Beijing, , China
Shanghai, , China
Fukuoka Shi, , Japan
Nagoya Shi, , Japan
Sapporo Shi, , Japan
Taipei, , Taiwan
Chuo Ku, , Japan
Matsuyama Shi, , Japan
Koto Ku, , Japan
Chengdu, , China
Hangzhou, , China
Nanjing, , China
Guangzhou, , China
Chiba Shi, , Japan
Seongnam Si, , Korea, Republic Of
Nanchang, , China
Seoul, , Korea, Republic Of
Takatsuki Shi, , Japan
Bengbu, , China
Changchun, , China
Changsha, , China
Fuzhou, , China
Harbin, , China
Urumqi, , China
Wanzhou, , China
Wuhan, , China
Yangzhou, , China
Zhengzhou, , China
Kasama Shi, , Japan
Kawasaki Shi, , Japan
Kitaadachi Gun, , Japan
Utsunomiya Shi, , Japan
Yokohama Shi, , Japan
Anyang Si, , Korea, Republic Of
Daegu, , Korea, Republic Of
Hwasun Gun, , Korea, Republic Of
Jeonju Si, , Korea, Republic Of
Kaohsiung Hsien, , Taiwan
Taoyuan, , Taiwan
Patients applied
Trial Officials
Yung-Jue Bang, MD
Principal Investigator
Seoul National University, College of Medicine and Cancer Research Institute, Republic of Korea
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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