Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
NCT ID: NCT03427814
Last Updated: 2024-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
136 participants
INTERVENTIONAL
2018-07-03
2023-01-03
Brief Summary
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Detailed Description
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Participants will undergo tumor assessments at screening and then every 8 weeks, or as clinically indicated. Administration of BGB-290 or placebo will continue until disease progression, unacceptable toxicity, death, or another discontinuation criterion is met.
After end of treatment, long-term follow-up assessments include tumor imaging every 8 weeks for those participants without disease progression, survival status, and new anticancer therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pamiparib
Participants received pamiparib orally.
Pamiparib
60 mg orally twice daily
Placebo
Participants received placebo orally.
Placebo
60 mg orally twice daily
Interventions
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Pamiparib
60 mg orally twice daily
Placebo
60 mg orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent.
3. Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
4. Received platinum based first line chemotherapy for ≤ 28 weeks.
5. Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).
6. Able to be randomized to study ≤ 8 weeks after last platinum dose.
7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
8. Adequate hematologic, renal and hepatic function.
9. Must be able to provide archival tumor tissue for central biomarker assessment.
10. Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 6 months after last dosing.
Exclusion Criteria
2. Prior treatment with PARP inhibitor.
3. Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days prior to randomization.
4. Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.
5. Diagnosis of myelodysplastic syndrome (MDS)
6. Other diagnoses of significant malignancy
7. Leptomeningeal disease or brain metastasis
8. Inability to swallow capsules or disease affecting gastrointestinal function.
9. Active infections requiring systemic treatment.
10. Clinically significant cardiovascular disease
11. Pregnant or nursing females.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Miami Cancer Institute
Miami, Florida, United States
Scri Florida Cancer Specialist East
West Palm Beach, Florida, United States
Goshen Center For Cancer Care
Goshen, Indiana, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Novant Health Hematology Charlotte
Charlotte, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Gosford Hospital
Gosford, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Ballarat Oncology and Haematology Services
Wendouree, Victoria, Australia
St John of God Health Care
Subiaco, Western Australia, Australia
Az Sint Jan Brugge
Bruges, , Belgium
University Hospitals Leuven
Leuven, , Belgium
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Fakultni Nemocnice Bulovka
Prague, , Czechia
Chru de Brest Hospital Morvan
Brest, , France
Chu Besancon Hopital Jean Minjoz
Doubs, , France
Hopital Prive Jean Mermoz
Lyon, , France
Icm Val Daurelle Oncologie Medicale
Montpellier, , France
Hopital Prive Des Cotes Darmor Service Oncologie
Plérin, , France
Centre Eugene Marquis
Rennes, , France
Ico Site Rene Gauducheau
SaintHerblain, , France
Iuc Toulouse Oncopole
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
Tbilisi, , Georgia
Queen Mary Hospital
Hong Kong, , Hong Kong
Orszagos Onkologiai Intezet
Budapest, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
Nho Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Kindai University Nara Hospital
Ikoma, Nara, Japan
Oita University Hospital
Yufushi, Oita Prefecture, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Osaka University Hospital
Suitashi, Osaka, Japan
Saitama Medical University International Medical Center
Hidakashi, Saitama, Japan
Showa University Koto Toyosu Hospital Oncology
Koto, Tokyo, Japan
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
Gdynia, , Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin, , Poland
Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
Warsaw, , Poland
Mazowiecki Szpital Onkologiczny
Wieliszew, , Poland
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk, Arkhangelskaya oblast, Russia
Regional Buz Kurskiy Regional Clinical Oncologic Dispensary
Kursk, Kursk Oblast, Russia
Bih of Omsk Region Clinical Oncology Dispensary
Omsk, Omsk Oblast, Russia
Pavlov First Saint Petersburg State Medical University
SaintPetersburg, Sankt-Peterburg, Russia
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
Volgograd, Volgograd Oblast, Russia
Tan Tock Seng Hospital Oncology
Singapore, , Singapore
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitario Vall Dhebron
Barcelona, , Spain
Institut Catala Doncologia
Barcelona, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario Hm Madrid Sanchinarro
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Clinica Universidad de Navarra Pamplona
Pamplona, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Chi Mei Medical Center
Tainan City, , Taiwan
Sarah Cannon Research Institute Uk
London, , United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003493-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTR20171664
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-290-303
Identifier Type: -
Identifier Source: org_study_id
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