Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
A Randomized, Double-blinded, Placebo Controlled, Multicentre Phase III Study to Assess the Efficacy and Safety of Olaparib (AZD2281) in Combination With Paclitaxel, Compared to Placebo in Combination With Paclitaxel, in Asian Patients With Advanced Gastric Cancer (Including the Gastro-oesophageal Junction) Who Have Progressed Following First Line Therapy
1 other identifier
interventional
525
4 countries
57
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 gastric-cancer
Started Sep 2013
Longer than P75 for phase_3 gastric-cancer
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedStudy Start
First participant enrolled
September 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2016
CompletedResults Posted
Study results publicly available
November 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2023
CompletedMarch 22, 2024
March 1, 2024
2.6 years
August 14, 2013
February 27, 2017
March 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Time from the date of randomization until death due to any cause
Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years
Secondary Outcomes (6)
Progression-Free Survival (PFS)
Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Number of Patients With Objective Response.
Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Number of Patients Objective Response
Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale
Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years
Time to Response
Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
- +1 more secondary outcomes
Study Arms (2)
Olaparib+ paclitaxel
EXPERIMENTALolaparib + paclitaxel
Placebo+paclitaxel
PLACEBO COMPARATORplacebo+ paclitaxel
Interventions
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.
IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (57)
Research Site
Beijing, 100021, China
Research Site
Beijing, 100071, China
Research Site
Beijing, 100142, China
Research Site
Bengbu, 233060, China
Research Site
Changchun, 130000, China
Research Site
Changsha, 410005, China
Research Site
Changsha, 410011, China
Research Site
Changsha, 410013, China
Research Site
Chengdu, 610041, China
Research Site
Chengdu, 610083, China
Research Site
Fuzhou, 350014, China
Research Site
Guangzhou, 510060, China
Research Site
Hangzhou, 310003, China
Research Site
Hangzhou, 310016, China
Research Site
Hangzhou, 310022, China
Research Site
Harbin, 150081, China
Research Site
Nanchang, 330006, China
Research Site
Nanjing, 210002, China
Research Site
Nanjing, 210009, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 200092, China
Research Site
Ürümqi, 830000, China
Research Site
Wanzhou, 404000, China
Research Site
Wuhan, 430030, China
Research Site
Yangzhou, 225001, China
Research Site
Zhengzhou, 450008, China
Research Site
Chiba, 260-8717, Japan
Research Site
Chūōku, 104-0045, Japan
Research Site
Fukuoka, 811-1395, Japan
Research Site
Kasama-shi, 309-1793, Japan
Research Site
Kawasaki-shi, 216-8511, Japan
Research Site
Kitaadachi-gun, 362-0806, Japan
Research Site
Kōtoku, 135-8550, Japan
Research Site
Matsuyama, 791-0280, Japan
Research Site
Nagoya, 464-8681, Japan
Research Site
Sapporo, 003-0804, Japan
Research Site
Sapporo, 060-8648, Japan
Research Site
Takatsuki-shi, 569-8686, Japan
Research Site
Utsunomiya, 320-0834, Japan
Research Site
Yokohama, 241-8515, Japan
Research Site
Anyang-si, 431-070, South Korea
Research Site
Daegu, 42415, South Korea
Research Site
Hwasun-gun, 58128, South Korea
Research Site
Jeonju, 561-712, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 02841, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 06273, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 156-707, South Korea
Research Site
Seoul, 6351, South Korea
Research Site
Kaohsiung Hsien, 83342, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, 704, Taiwan
Research Site
Taipei, 11217, Taiwan
Research Site
Taoyuan District, 333, Taiwan
Related Publications (1)
Bang YJ, Xu RH, Chin K, Lee KW, Park SH, Rha SY, Shen L, Qin S, Xu N, Im SA, Locker G, Rowe P, Shi X, Hodgson D, Liu YZ, Boku N. Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1637-1651. doi: 10.1016/S1470-2045(17)30682-4. Epub 2017 Nov 2.
PMID: 29103871DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gershon Locker Global Clinical Lead (GCL)
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Yung-Jue Bang, MD
Seoul National University, College of Medicine and Cancer Research Institute, Republic of Korea
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2013
First Posted
August 16, 2013
Study Start
September 3, 2013
Primary Completion
April 4, 2016
Study Completion
March 27, 2023
Last Updated
March 22, 2024
Results First Posted
November 7, 2018
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.