Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
- Conditions
- Advanced or Inoperable Gastric Cancer
- Interventions
- Drug: PlaceboDrug: Pamiparib
- Registration Number
- NCT03427814
- Lead Sponsor
- BeiGene
- 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.
- Detailed Description
This is a double-blind, placebo controlled, randomized multicenter global phase 2 study comparing the efficacy and safety of single agent poly (ADP-ribose) polymerase (PARP) inhibitor BGB-290 to placebo as maintenance therapy in participants with advanced gastric cancer who have responded to first line platinum based chemotherapy. Participants are randomized 1:1 to BGB-290 (Arm A) or placebo (Arm B). Randomization will be stratified by geography, biomarker status, and ECOG performance status.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- 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.
Key
- 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.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received placebo orally. Pamiparib Pamiparib Participants received pamiparib orally.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) by Investigator Assessment Approximately 23 months 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.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Approximately 23 months DOR is defined as the time from the first documented confirmed response of Complete Response or Partial Response to progressive disease (PD) per RECIST Version 1.1 by investigator assessment or death due to any cause, whichever occurs first
Time To Response Approximately 23 months Time to response is defined as the time from randomization to the first documented response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months) Overall Survival (OS) Approximately 23 months OS is defined as the time from randomization to death due to any cause.
Time To Second Subsequent Treatment (TSST) Approximately 23 months TSST is defined as the time from randomization until the second subsequent anticancer therapy or death after next-line therapy
Objective Response Rate (ORR) Approximately 23 months ORR is defined as the percentage of participants with a best overall response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment
Trial Locations
- Locations (65)
Scri Florida Cancer Specialist East
🇺🇸West Palm Beach, Florida, United States
Goshen Center For Cancer Care
🇺🇸Goshen, Indiana, 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
St John of God Health Care
🇦🇺Subiaco, Western Australia, Australia
Az Sint Jan Brugge
🇧🇪Brugge, Belgium
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, 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
The Affiliated Hospital of Qingdao University Branch South
🇨🇳Qingdao, Shandong, China
Liaoning Cancer Hospital and Institute
🇨🇳Shenyang, Liaoning, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Affiliated Zhongshan Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Fakultni Nemocnice Bulovka
🇨🇿Praha, 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
🇫🇷Plerin, France
Centre Eugene Marquis
🇫🇷Rennes, France
Pecsi Tudomanyegyetem Klinikai Kozpont
🇭🇺Pecs, Hungary
Ico Site Rene Gauducheau
🇫🇷SaintHerblain, France
Iuc Toulouse Oncopole
🇫🇷Toulouse, France
Nho Kyushu Cancer Center
🇯🇵Fukuokashi, Fukuoka, Japan
Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
🇬🇪Tbilisi, Georgia
Orszagos Onkologiai Intezet
🇭🇺Budapest, Hungary
Kindai University Nara Hospital
🇯🇵Ikoma, Nara, Japan
Oita University Hospital
🇯🇵Yufushi, Oita, 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
🇵🇱Warszawa, Poland
Arkhangelsk Regional Clinical Oncological Dispensary
🇷🇺Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation
Regional Buz Kurskiy Regional Clinical Oncologic Dispensary
🇷🇺Kursk, Kurskaya Oblast', Russian Federation
Bih of Omsk Region Clinical Oncology Dispensary
🇷🇺Omsk, Omskaya Oblast', Russian Federation
Institut Gustave Roussy
🇫🇷Villejuif, France
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Kindai University Hospital
🇯🇵Osakasayama, Osaka, Japan
Chi Mei Medical Center
🇨🇳Tainan, Taiwan
Miami Cancer Institute
🇺🇸Miami, Florida, United States
Mazowiecki Szpital Onkologiczny
🇵🇱Wieliszew, Poland
Pavlov First Saint Petersburg State Medical University
🇷🇺SaintPetersburg, Sankt-Peterburg, Russian Federation
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
🇷🇺Volgograd, Volgogradskaya Oblast', Russian Federation
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
Sarah Cannon Research Institute Uk
🇬🇧London, United Kingdom
Clatterbridge Cancer Centre
🇬🇧Wirral, United Kingdom
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Monash Health
🇦🇺Clayton, Victoria, Australia
Ballarat Oncology and Haematology Services
🇦🇺Wendouree, Victoria, Australia
University Hospitals Leuven
🇧🇪Leuven, Belgium