Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
A Phase 2, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy
3 other identifiers
interventional
136
16 countries
65
Brief Summary
This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2018
Typical duration for phase_2
65 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
February 5, 2018
CompletedFirst Posted
Study publicly available on registry
February 9, 2018
CompletedStudy Start
First participant enrolled
July 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2023
CompletedResults Posted
Study results publicly available
September 21, 2023
CompletedOctober 26, 2024
October 1, 2024
2 years
February 5, 2018
August 24, 2023
October 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) by Investigator Assessment
PFS is defined as the time from randomization to progressive disease (PD) per Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.
Approximately 23 months
Secondary Outcomes (6)
Overall Survival (OS)
Approximately 23 months
Time To Second Subsequent Treatment (TSST)
Approximately 23 months
Objective Response Rate (ORR)
Approximately 23 months
Duration of Response (DOR)
Approximately 23 months
Time To Response
Approximately 23 months
- +1 more secondary outcomes
Study Arms (2)
Pamiparib
EXPERIMENTALParticipants received pamiparib orally.
Placebo
PLACEBO COMPARATORParticipants received placebo orally.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years.
- Signed informed consent.
- Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
- Received platinum based first line chemotherapy for ≤ 28 weeks.
- Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).
- Able to be randomized to study ≤ 8 weeks after last platinum dose.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Adequate hematologic, renal and hepatic function.
- Must be able to provide archival tumor tissue for central biomarker assessment.
- 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.
You may not qualify if:
- Unresolved acute effects of prior therapy ≥ Grade 2.
- Prior treatment with PARP inhibitor.
- Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days prior to randomization.
- Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.
- Diagnosis of myelodysplastic syndrome (MDS)
- Other diagnoses of significant malignancy
- Leptomeningeal disease or brain metastasis
- Inability to swallow capsules or disease affecting gastrointestinal function.
- Active infections requiring systemic treatment.
- Clinically significant cardiovascular disease
- Pregnant or nursing females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (65)
Miami Cancer Institute
Miami, Florida, 33176, United States
Scri Florida Cancer Specialist East
West Palm Beach, Florida, 33401, United States
Goshen Center For Cancer Care
Goshen, Indiana, 46526, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Norton Cancer Institute
Louisville, Kentucky, 40217, United States
Novant Health Hematology Charlotte
Charlotte, North Carolina, 28204, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Gosford Hospital
Gosford, New South Wales, 2250, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Ballarat Oncology and Haematology Services
Wendouree, Victoria, 3355, Australia
St John of God Health Care
Subiaco, Western Australia, 6008, Australia
Az Sint Jan Brugge
Bruges, 8000, Belgium
University Hospitals Leuven
Leuven, 3000, Belgium
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong, 266000, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
Fakultni Nemocnice Bulovka
Prague, 18081, Czechia
Chru de Brest Hospital Morvan
Brest, 29200, France
Chu Besancon Hopital Jean Minjoz
Doubs, 25030, France
Hopital Prive Jean Mermoz
Lyon, 69008, France
Icm Val Daurelle Oncologie Medicale
Montpellier, 24298, France
Hopital Prive Des Cotes Darmor Service Oncologie
Plérin, 22190, France
Centre Eugene Marquis
Rennes, 35043, France
Ico Site Rene Gauducheau
SaintHerblain, 44805, France
Iuc Toulouse Oncopole
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
Tbilisi, 0112, Georgia
Queen Mary Hospital
Hong Kong, Hong Kong
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, H-7624, Hungary
Nho Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Kindai University Nara Hospital
Ikoma, Nara, 630-0293, Japan
Oita University Hospital
Yufushi, Oita Prefecture, 879-5593, Japan
Kindai University Hospital
Sayama, Osaka, 589-8511, Japan
Osaka University Hospital
Suitashi, Osaka, 565-0871, Japan
Saitama Medical University International Medical Center
Hidakashi, Saitama, 350-1298, Japan
Showa University Koto Toyosu Hospital Oncology
Koto, Tokyo, 135-8577, Japan
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
Gdynia, 81-519, Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin, 20-090, Poland
Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
Warsaw, 02-034, Poland
Mazowiecki Szpital Onkologiczny
Wieliszew, 05-135, Poland
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk, Arkhangelskaya oblast, 163045, Russia
Regional Buz Kurskiy Regional Clinical Oncologic Dispensary
Kursk, Kursk Oblast, 305035, Russia
Bih of Omsk Region Clinical Oncology Dispensary
Omsk, Omsk Oblast, 644013, Russia
Pavlov First Saint Petersburg State Medical University
SaintPetersburg, Sankt-Peterburg, 197022, Russia
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
Volgograd, Volgograd Oblast, 400138, Russia
Tan Tock Seng Hospital Oncology
Singapore, 308433, Singapore
Hospital de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital Universitario Vall Dhebron
Barcelona, 08035, Spain
Institut Catala Doncologia
Barcelona, 08908, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario Hm Madrid Sanchinarro
Madrid, 28050, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Clinica Universidad de Navarra Pamplona
Pamplona, 31008, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Chi Mei Medical Center
Tainan, 710, Taiwan
Sarah Cannon Research Institute Uk
London, W1G 6AD, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2018
First Posted
February 9, 2018
Study Start
July 3, 2018
Primary Completion
June 18, 2020
Study Completion
January 3, 2023
Last Updated
October 26, 2024
Results First Posted
September 21, 2023
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share