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

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.

Study Overview

• Status: Completed
• Conditions: Advanced or Inoperable Gastric Cancer
• Intervention / Treatment: Drug: Pamiparib; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Gosford, New South Wales, Australia, 2250
      • Gosford Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health
    • Wendouree, Victoria, Australia, 3355
      • Ballarat Oncology And Haematology Services
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • St John of God Health Care
• Belgium
  • Brugge, Belgium, 8000
    • Az Sint Jan Brugge
  • Leuven, Belgium, 3000
    • University Hospitals Leuven
• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Anhui Provincial Hospital
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat Sen University Cancer Center
    • Shantou, Guangdong, China, 515031
      • Cancer Hospital of Shantou University Medical College
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital and Institute
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
    • Qingdao, Shandong, China, 266000
      • The Affiliated Hospital of Qingdao University Branch South
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Affiliated Zhongshan Hospital of Fudan University
• Czechia
  • Praha, Czechia, 18081
    • Fakultni Nemocnice Bulovka
• France
  • Brest, France, 29200
    • Chru de Brest Hospital Morvan
  • Doubs, France, 25030
    • CHU Besançon Hopital Jean Minjoz
  • Lyon, France, 69008
    • Hopital Prive Jean Mermoz
  • Montpellier, France, 24298
    • Icm Val Daurelle Oncologie Medicale
  • Plerin, France, 22190
    • Hopital Prive Des Cotes Darmor Service Oncologie
  • Rennes, France, 35043
    • Centre Eugène Marquis
  • SaintHerblain, France, 44805
    • Ico Site Rene Gauducheau
  • Toulouse, France, 31059
    • Iuc Toulouse Oncopole
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Georgia
  • Tbilisi, Georgia, 0112
    • Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
• Hungary
  • Budapest, Hungary, 1122
    • Országos Onkológiai Intézet
  • Pecs, Hungary, H-7624
    • Pécsi Tudományegyetem Klinikai Központ
• Japan
  • Fukuoka
    • Fukuokashi, Fukuoka, Japan, 811-1395
      • Nho Kyushu Cancer Center
  • Nara
    • Ikoma, Nara, Japan, 630-0293
      • Kindai University Nara Hospital
  • Oita
    • Yufushi, Oita, Japan, 879-5593
      • Oita University Hospital
  • Osaka
    • Osakasayama, Osaka, Japan, 589-8511
      • Kindai University Hospital
    • Suitashi, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Saitama
    • Hidakashi, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center
  • Tokyo
    • Koto, Tokyo, Japan, 135-8577
      • Showa University Koto Toyosu Hospital Oncology
• Poland
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie spolka z ograniczona odpowiedzialnoscia
  • Lublin, Poland, 20-090
    • Centrum Onkologii Ziemi Lubelskiej
  • Warszawa, Poland, 02-034
    • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
  • Wieliszew, Poland, 05-135
    • Mazowiecki Szpital Onkologiczny
• Russian Federation
  • Arkhangel'skaya Oblast'
    • Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation, 163045
      • Arkhangelsk Regional Clinical Oncological Dispensary
  • Kurskaya Oblast'
    • Kursk, Kurskaya Oblast', Russian Federation, 305035
      • Regional Buz Kurskiy Regional Clinical Oncologic Dispensary
  • Omskaya Oblast'
    • Omsk, Omskaya Oblast', Russian Federation, 644013
      • Bih of Omsk Region Clinical Oncology Dispensary
  • Sankt-Peterburg
    • SaintPetersburg, Sankt-Peterburg, Russian Federation, 197022
      • Pavlov First Saint Petersburg State Medical University
  • Volgogradskaya Oblast'
    • Volgograd, Volgogradskaya Oblast', Russian Federation, 400138
      • State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital Oncology
• Spain
  • Barcelona, Spain, 08025
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall Dhebron
  • Barcelona, Spain, 08908
    • Institut Catala Doncologia
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28050
    • Hospital Universitario HM Madrid Sanchinarro
  • Majadahonda, Spain, 28222
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra Pamplona
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
• Taiwan
  • Tainan, Taiwan, 710
    • Chi Mei Medical Center
• United Kingdom
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute UK
  • Wirral, United Kingdom, CH63 4JY
    • Clatterbridge Cancer Centre
• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Miami Cancer Institute
    • West Palm Beach, Florida, United States, 33401
      • Scri Florida Cancer Specialist East
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Goshen Center for Cancer Care
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Norton Cancer Institute
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Hematology Charlotte
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Age ≥ 18 years.
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.

Key Exclusion Criteria:

1. Unresolved acute effects of prior therapy ≥ Grade 2.
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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pamiparib; Participants received pamiparib orally.	Drug: Pamiparib; 60 mg orally twice daily; Other Names: BGB-290
Placebo Comparator: Placebo; Participants received placebo orally.	Drug: Placebo; 60 mg orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Approximately 23 months
Time To Second Subsequent Treatment (TSST)	TSST is defined as the time from randomization until the second subsequent anticancer therapy or death after next-line therapy	Approximately 23 months
Objective Response Rate (ORR)	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	Approximately 23 months
Duration of Response (DOR)	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	Approximately 23 months
Time To Response	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	Approximately 23 months
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)

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Study Director, BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2018
• Primary Completion (Actual): June 18, 2020
• Study Completion (Actual): January 3, 2023

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: PARP inhibitor; gastric cancer; Phase 2; maintenance therapy; BGB-290; oral treatment; PARALLEL 303; PARALLEL; BGB290303; BGB-290-303
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Poly(ADP-ribose) Polymerase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Pamiparib
• Other Study ID Numbers: BGB-290-303; 2017-003493-13 (EudraCT Number); CTR20171664 (Registry Identifier: Center for drug evaluation NMPA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No