Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
NCT ID: NCT01924533
Last Updated: 2024-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
525 participants
INTERVENTIONAL
2013-09-03
2023-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Olaparib+ paclitaxel
olaparib + paclitaxel
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.
Paclitaxel
IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.
Placebo+paclitaxel
placebo+ paclitaxel
Paclitaxel
IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.
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.
Interventions
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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.
Paclitaxel
IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Yung-Jue Bang, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University, College of Medicine and Cancer Research Institute, Republic of Korea
Locations
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Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Bengbu, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Changsha, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Chengdu, , China
Research Site
Fuzhou, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Harbin, , China
Research Site
Nanchang, , China
Research Site
Nanjing, , China
Research Site
Nanjing, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Ürümqi, , China
Research Site
Wanzhou, , China
Research Site
Wuhan, , China
Research Site
Yangzhou, , China
Research Site
Zhengzhou, , China
Research Site
Chiba, , Japan
Research Site
Chūōku, , Japan
Research Site
Fukuoka, , Japan
Research Site
Kasama-shi, , Japan
Research Site
Kawasaki-shi, , Japan
Research Site
Kitaadachi-gun, , Japan
Research Site
Kōtoku, , Japan
Research Site
Matsuyama, , Japan
Research Site
Nagoya, , Japan
Research Site
Sapporo, , Japan
Research Site
Sapporo, , Japan
Research Site
Takatsuki-shi, , Japan
Research Site
Utsunomiya, , Japan
Research Site
Yokohama, , Japan
Research Site
Anyang-si, , South Korea
Research Site
Daegu, , South Korea
Research Site
Hwasun-gun, , South Korea
Research Site
Jeonju, , South Korea
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Kaohsiung Hsien, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Countries
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References
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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.
Related Links
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Other Identifiers
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D081BC00004
Identifier Type: -
Identifier Source: org_study_id
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