Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer

August 24, 2023 updated by: BeiGene

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Central Coast Local Health District
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • The Townsville Hospital and Health Service
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health
      • Epping, Victoria, Australia, 3076
        • Northern Hospital
      • Wendouree, Victoria, Australia, 3355
        • Ballarat Oncology and Haematology Services
  • Belgium
      • Liège, Belgium, 4000
        • CHU de Liège - Domaine Universitaire du Sart Tilman
    • Antwerpen
      • Wilrijk, Antwerpen, Belgium, 2610
        • UZ Antwerpen
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Az Maria Middelares - Campus Maria Middelares
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • University Hospitals Leuven
    • West-Vlaanderen
      • Brugge, West-Vlaanderen, Belgium, 8000
        • AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
  • China
      • Guangzhou, China, 510060
        • Sun Yat-sen University - Cancer Center (SYSUCC)
      • Nanjing, China
        • Nanjing Drum Tower Hospital
    • Anhui
      • Hefei, Anhui, China, 230022
        • The First affiliated Hospital of Anhui Medical University
      • Hefei, Anhui, China, 230601
        • Anhui Medical University - The Second Hospital
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital - Digestive Tumor Medical
    • Fujian
      • Xiamen, Fujian, China
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital
      • Guangzhou, Guangdong, China
        • The Sixth Affiliated Hospital of Sun Yat-sen University
      • Shantou, Guangdong, China, 515031
        • Cancer Hospital of Shantou University Medical College - Oncology
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital - Oncology
    • Henan
      • Xinxiang, Henan, China, 453100
        • The First Affiliated Hospital of Xinxiang Medical University
      • Zhengzhou, Henan, China, 450052
        • The first affiliated hospital of Zhengzhou University - Oncology - Oncology
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • 1st Affiliated Hospital of Nanjing Medical U
      • Suzhou, Jiangsu, China, 215000
        • The Second Affiliated Hospital of Soochow University
      • Xuzhou, Jiangsu, China
        • The Affiliated Hospital of Xuzhou Medical University
      • Yangzhou, Jiangsu, China, 225001
        • Northern Jiangsu people's hospital - Oncology
    • Liaoning
      • Shenyang, Liaoning, China
        • Liaoning Cancer Hospital & Institute - Medical Oncology
    • Shandong
      • Qingdao, Shandong, China
        • The Affiliated Hospital of Qingdao University
    • Shanghai
      • Shanghai, Shanghai, China
        • Zhongshan Hospital Fudan University
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital of Zhejiang University
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  • Czechia
      • Olomouc, Czechia, 779 00
        • Fakultní nemocnice Olomouc
      • Praha, Czechia, 4 140 59
        • Thomayerova nemocnice
  • France
      • Angers Cedex 02, France, 49055
        • Institut de Cancérologie de l'Ouest
      • Angers Cedex 2, France, 49055
        • ICO
    • Alpes Maritimes
      • Nice Cedex 3, Alpes Maritimes, France, 06200
        • CHU Nice - Hôpital de l'Archet 2
    • Bretagne
      • Brest Cedex, Bretagne, France, 29609
        • Hôpital Morvan - CHRU de Brest
      • Plérin, Bretagne, France, 22190
        • Hôpital Privé des Côtes d'Armor - Service oncologie
    • Franche-Comté
      • Besançon cedex, Franche-Comté, France, 25033
        • University Hospital of Besancon
    • Haute-Garonne
      • Toulouse cedex 9, Haute-Garonne, France, 31059
        • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35042
        • Centre Eugène Marquis
    • Languedoc-Roussillon
      • Montpellier Cedex 5, Languedoc-Roussillon, France, 34298
        • ICM Val D'Aurelle
    • Rhône
      • Lyon, Rhône, France, 69008
        • Hopital Prive Jean Mermoz
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Hospital of Poitiers
    • Île-de-France
      • Paris cedex 13, Île-de-France, France, 75651
        • Pitié Salpetriere - Gastroenterology
      • Villejuif, Île-de-France, France, 94805
        • Institut Gustave Roussy
  • Georgia
      • Tbilisi, Georgia, 186
        • Multiprofile Clinic Consilium Medulla LTD
      • Tbilisi, Georgia, 186
        • Scientific Research Center of Oncology LTD
    • Tamar
      • Melkadze, Tamar, Georgia, 0112
        • LTD Acad.F.Todua Medical Center -Research Institute of Clinical Medicine
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • Hungary
      • Budapest, Hungary, 1122
        • Országos Onkológiai Intézet
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Pécs, Hungary, H-7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5004
        • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
  • Japan
      • Chuo Ku, Japan, 104-0045
        • National Cancer Center Hospital
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Hirakata, Japan, 573-1191
        • Kansai Medical University Hospital
      • Hyōgo, Japan, 663-8501
        • Hyogo College of Medicine College Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Osaka, Japan, 540-0006
        • National Hospital Organization - Osaka National Hospital
      • Osaka, Japan, 989-6183
        • Osaki Citizen Hospital
      • Osaka-shi, Japan, 537-8511
        • Osaka International Cancer Institute - Medical Oncology
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Sapporo, Japan, 060-8648
        • Hokkaido University Hospital
      • Takatsuki, Japan, 569-8686
        • Osaka Medical College Hospital
      • Utsunomiya, Japan, 3200-834
        • Tochigi Cancer Center
    • Aiti [Aichi]
      • Nagoya, Aiti [Aichi], Japan, 464-8681
        • Aichi Cancer Center Hospital - Clinical Oncology
    • Histao
      • Kawakami, Histao, Japan, 589-8511
        • Kindai University Hospital
    • Hukuoka [Fukuoka]
      • Kitakyushu-shi, Hukuoka [Fukuoka], Japan, 806-8501
        • Japan Community Health Care Organization (JCHO) Kyushu Hospital - Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna University School of Medicine Hospital
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Hospital - Medical Oncology
  • Poland
      • Gdynia, Poland, 81-519
        • Szpitale Pomorskie Sp. z o.o.
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
      • Poznan, Poland, 60-569
        • Clinical Research Center Sp. z o.o., Medic-R Sp. K.
    • Lódzkie
      • Łódź, Lódzkie, Poland, 93-513
        • Salve Medica
    • Mazowieckie
      • Wieliszew, Mazowieckie, Poland, 05-135
        • Mazowiecki Szpital Onkologiczny
    • Podkarpackie
      • Brzozow, Podkarpackie, Poland, 36-200
        • Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi
  • Romania
      • Bucuresti, Romania, 03748
        • Med Life
      • Bucuresti, Romania, 31422
        • Gral Medical
      • Cluj-Napoca, Romania, 400641
        • Medisprof
      • Constanţa, Romania, 900591
        • Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta
      • Craiova, Romania, 200385
        • Oncolab
  • Russian Federation
      • Krasnodar, Russian Federation, 35004
        • Guz Clinical Oncology Dispensary #1
      • Moscow, Russian Federation, 105229
        • Main Military Hospital n.a. Burdenko
      • Perm, Russian Federation, 614066
        • GUZ Perm Regional Oncology Dispensary
      • Saint Petersburg, Russian Federation, 191104
        • N.N. Petrov Research Institute of Oncology
      • Saint Petersburg, Russian Federation, 195067
        • GBOU VPO NorthWestern State Medical University n.a. I.I. Mec
      • Samara, Russian Federation, 443031
        • Samara Regional Clinical Oncology Dispensary :
      • Volgograd, Russian Federation, 400138
        • GBUZ "Regional clinical oncologic dispensary of Volgograd"
    • Krasnodarskiy Kray
      • Krasnodar, Krasnodarskiy Kray, Russian Federation, 350040
        • Guz Clinical Oncology Dispensary #1
  • Singapore
      • Singapore, Singapore, 169210
        • National Cancer Centre Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 169610
        • National Cancer Centre
      • Singapore, Central Singapore, Singapore, 188770
        • Raffles Hospital
      • Singapore, Central Singapore, Singapore, 308433
        • Tan Tock Seng Hospital - Oncology
  • Spain
      • Alcorcón, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 8003
        • Hospital Del Mar
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañon
      • Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena.
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Universtiario Miguel Servet.
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Institut Catalá d´Oncología (I.C.O.)
    • Madrid
      • Alcorcon, Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra
  • Taiwan
      • Tainan, Taiwan, 710
        • Chi Mei Medical Center
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital - Neihu Branch - Hematology
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas NHS Foundation Trust
      • London, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
      • Northwood, United Kingdom, HA6 2RN
        • East and North Hertfordshire NHS Trust
      • Peterborough, United Kingdom, PE3 9GZ
        • Peterborough And Stamford Hospitals - Haematology & Oncology
      • Peterborough, United Kingdom, PE3 9GZ
        • Peterborough And Stamford Hospitals
    • Greater London
      • London, Greater London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute UK
      • London, Greater London, United Kingdom, SE1 9RT
        • NHS - Guy's & St Thomas' Hospital - Medical Oncology
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust
  • United States
    • California
      • Santa Rosa, California, United States, 95403
        • St Joseph Heritage Healthcare
    • Florida
      • Miami, Florida, United States, 33136
        • Sylvester Comprehensive Cancer Center
      • Miami, Florida, United States, 33176
        • Baptist Health Medical Group Oncology, LLC - Research Center
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists - Hematology/Oncology
    • 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, 28204-3193
        • Novant Health & Presbyterian Healthcare - Presbyterian Hospi
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center - Oncology
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University Knight Cancer Institute - Hematology Medical Oncology - Hematology Medical Oncology
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center (VUMC)
    • Texas
      • The Woodlands, Texas, United States, 77090
        • Renovatio Clincal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
Approximately 23 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Approximately 23 months
OS is defined as the time from randomization to death due to any cause.
Approximately 23 months
Time To Second Subsequent Treatment (TSST)
Time Frame: Approximately 23 months
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)
Time Frame: 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
Approximately 23 months
Duration of Response (DOR)
Time Frame: 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
Approximately 23 months
Time To Response
Time Frame: 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
Approximately 23 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: 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)
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

This is where you will find people and organizations involved with this study.

Sponsor

BeiGene

Investigators

  • Study Director: Study Director, BeiGene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

September 21, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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