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

Primary Purpose

Advanced or Inoperable Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pamiparib
Placebo
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced or Inoperable Gastric Cancer focused on measuring BGB-290, PARP inhibitor, Phase 2, maintenance therapy, gastric cancer, oral treatment, PARALLEL 303, PARALLEL, BGB290303, BGB-290-303

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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) or active bleeding disorder.
  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.

Sites / Locations

  • St Joseph Heritage Healthcare
  • Sylvester Comprehensive Cancer Center
  • Baptist Health Medical Group Oncology, LLC - Research Center
  • Florida Cancer Specialists - Hematology/Oncology
  • Goshen Center for Cancer Care
  • Cancer Center of Kansas
  • Norton Cancer Institute
  • Novant Health & Presbyterian Healthcare - Presbyterian Hospi
  • Stephenson Cancer Center - Oncology
  • Oregon Health and Science University Knight Cancer Institute - Hematology Medical Oncology - Hematology Medical Oncology
  • The Sarah Cannon Research Institute
  • Vanderbilt University Medical Center (VUMC)
  • Renovatio Clincal
  • Central Coast Local Health District
  • The Townsville Hospital and Health Service
  • Monash Health
  • Northern Hospital
  • Ballarat Oncology and Haematology Services
  • UZ Antwerpen
  • AZ Maria Middelares - Campus Maria Middelares
  • UZ Gent
  • University Hospitals Leuven
  • AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
  • CHU de Liège - Domaine Universitaire du Sart Tilman
  • The First Affiliated Hospital of Anhui Medical University
  • Anhui Medical University - The Second Hospital
  • Beijing Cancer Hospital - Digestive Tumor Medical
  • The First Affiliated Hospital of Xiamen University
  • Guangdong General Hospital
  • Nanfang Hospital
  • The Sixth Affiliated Hospital of Sun Yat-sen University
  • Cancer Hospital of Shantou University Medical College - Oncology
  • Harbin Medical University Cancer Hospital - Oncology
  • The First Affiliated Hospital of Xinxiang Medical University
  • The first affiliated hospital of Zhengzhou University - Oncology - Oncology
  • Hunan Cancer Hospital
  • 1st Affiliated Hospital of Nanjing Medical U
  • The Second Affiliated Hospital of Soochow University
  • The Affiliated Hospital of Xuzhou Medical University
  • Northern Jiangsu people's hospital - Oncology
  • Liaoning Cancer Hospital & Institute - Medical Oncology
  • The Affiliated Hospital Of Qingdao University
  • Zhongshan Hospital Fudan University
  • Tianjin Cancer Hospital
  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  • Zhejiang Cancer Hospital
  • The Second Affiliated Hospital of Zhejiang University
  • Sun Yat-sen University - Cancer Center (SYSUCC)
  • Nanjing Drum Tower Hospital
  • Fakultni nemocnice Olomouc
  • Thomayerova nemocnice
  • CHU Nice - Hôpital de l'Archet 2
  • Hôpital Morvan - CHRU de Brest
  • Hôpital Privé des Côtes d'Armor - Service oncologie
  • University Hospital of Besançon
  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital
  • Centre Eugène Marquis
  • ICM Val d'Aurelle
  • Hopital Privé Jean Mermoz
  • Hospital of Poitiers
  • Institut de Cancérologie de l'Ouest
  • ICO
  • Pitié Salpetriere - Gastroenterology
  • Institut Gustave Roussy
  • LTD Acad.F.Todua Medical Center -Research Institute of Clinical Medicine
  • Multiprofile Clinic Consilium Medulla LTD
  • Scientific Research Center of Oncology LTD
  • Queen Mary Hospital
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
  • Semmelweis Egyetem
  • Országos Onkológiai Intézet
  • Semmelweis Egyetem
  • Debreceni Egyetem Klinikai Központ
  • Pécsi Tudományegyetem Klinikai Központ
  • Aichi Cancer Center Hospital - Clinical Oncology
  • Kindai University Hospital
  • Japan Community Health Care Organization (JCHO) Kyushu Hospital - Hospital
  • St. Marianna University School of Medicine Hospital
  • Osaka University Hospital - Medical Oncology
  • National Cancer Center Hospital
  • National Hospital Organization Kyushu Cancer Center
  • Kansai Medical University Hospital
  • Hyogo College of Medicine College Hospital
  • Kumamoto University Hospital
  • Osaka International Cancer Institute - Medical Oncology
  • National Hospital Organization - Osaka National Hospital
  • Osaki Citizen Hospital
  • Saitama Cancer Center
  • Hokkaido University Hospital
  • Osaka Medical College Hospital
  • Tochigi Cancer Center
  • Salve Medica
  • Mazowiecki Szpital Onkologiczny
  • Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi
  • Szpitale Pomorskie Sp. z o.o.
  • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
  • Clinical Research Center Sp. z o.o., Medic-R Sp. K.
  • Med Life
  • Gral Medical
  • Medisprof
  • Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta
  • Oncolab
  • Guz Clinical Oncology Dispensary #1
  • Guz Clinical Oncology Dispensary #1
  • Main Military Hospital n.a. Burdenko
  • GUZ Perm Regional Oncology Dispensary
  • N.N. Petrov Research Institute of Oncology
  • GBOU VPO NorthWestern State Medical University n.a. I.I. Mec
  • Samara Regional Clinical Oncology Dispensary :
  • GBUZ "Regional clinical oncologic dispensary of Volgograd"
  • National Cancer Centre
  • Raffles Hospital
  • Tan Tock Seng Hospital - Oncology
  • National Cancer Centre Singapore
  • Institut Catalá d´Oncología (I.C.O.)
  • Hospital Universitario Fundación Jiménez Díaz
  • Clínica Universidad de Navarra
  • Hospital Universitario Fundacion Alcorcon
  • Hospital de La Santa Creu i Sant Pau
  • Hospital Universitario Vall d'Hebrón
  • Hospital del Mar
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario Gregorio Marañon
  • Hospital Universitario Ramón Y Cajal
  • Hospital Madrid Norte Sanchinarro
  • Hospital Universitario Virgen Macarena.
  • Hospital Clínico de Valencia
  • Hospital Universtiario Miguel Servet.
  • Chi Mei Medical Center
  • Tri-Service General Hospital - Neihu Branch - Hematology
  • Tri-Service General Hospital
  • NHS - Guy's & St Thomas' Hospital - Medical Oncology
  • Sarah Cannon Research Institute UK
  • Nottingham University Hospitals NHS Trust
  • Royal Berkshire Hospital
  • Guy's and St Thomas NHS Foundation Trust
  • East and North Hertfordshire NHS Trust
  • Mount Vernon Hospital
  • Peterborough And Stamford Hospitals - Haematology & Oncology
  • Peterborough And Stamford Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pamiparib

Placebo

Arm Description

Participants received pamiparib orally.

Participants received placebo orally.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
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
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
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
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
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Full Information

First Posted
February 5, 2018
Last Updated
August 24, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03427814
Brief Title
Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
June 18, 2020 (Actual)
Study Completion Date
January 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Inoperable Gastric Cancer
Keywords
BGB-290, PARP inhibitor, Phase 2, maintenance therapy, gastric cancer, oral treatment, PARALLEL 303, PARALLEL, BGB290303, BGB-290-303

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pamiparib
Arm Type
Experimental
Arm Description
Participants received pamiparib orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo orally.
Intervention Type
Drug
Intervention Name(s)
Pamiparib
Other Intervention Name(s)
BGB-290
Intervention Description
60 mg orally twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
60 mg orally twice daily
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) by Investigator Assessment
Description
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.
Time Frame
Approximately 23 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Approximately 23 months
Title
Time To Second Subsequent Treatment (TSST)
Description
TSST is defined as the time from randomization until the second subsequent anticancer therapy or death after next-line therapy
Time Frame
Approximately 23 months
Title
Objective Response Rate (ORR)
Description
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
Time Frame
Approximately 23 months
Title
Duration of Response (DOR)
Description
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 Frame
Approximately 23 months
Title
Time To Response
Description
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
Time Frame
Approximately 23 months
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
BeiGene
Official's Role
Study Director
Facility Information:
Facility Name
St Joseph Heritage Healthcare
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Baptist Health Medical Group Oncology, LLC - Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Cancer Specialists - Hematology/Oncology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Goshen Center for Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Novant Health & Presbyterian Healthcare - Presbyterian Hospi
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204-3193
Country
United States
Facility Name
Stephenson Cancer Center - Oncology
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health and Science University Knight Cancer Institute - Hematology Medical Oncology - Hematology Medical Oncology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center (VUMC)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Renovatio Clincal
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Central Coast Local Health District
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
The Townsville Hospital and Health Service
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Northern Hospital
City
Epping
State/Province
Victoria
ZIP/Postal Code
3076
Country
Australia
Facility Name
Ballarat Oncology and Haematology Services
City
Wendouree
State/Province
Victoria
ZIP/Postal Code
3355
Country
Australia
Facility Name
UZ Antwerpen
City
Wilrijk
State/Province
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
Facility Name
AZ Maria Middelares - Campus Maria Middelares
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
CHU de Liège - Domaine Universitaire du Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Anhui Medical University - The Second Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
Beijing Cancer Hospital - Digestive Tumor Medical
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The Sixth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College - Oncology
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515031
Country
China
Facility Name
Harbin Medical University Cancer Hospital - Oncology
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453100
Country
China
Facility Name
The first affiliated hospital of Zhengzhou University - Oncology - Oncology
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
1st Affiliated Hospital of Nanjing Medical U
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Northern Jiangsu people's hospital - Oncology
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
Liaoning Cancer Hospital & Institute - Medical Oncology
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
The Affiliated Hospital Of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Sun Yat-sen University - Cancer Center (SYSUCC)
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
Country
China
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Praha
ZIP/Postal Code
4 140 59
Country
Czechia
Facility Name
CHU Nice - Hôpital de l'Archet 2
City
Nice Cedex 3
State/Province
Alpes Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
Hôpital Morvan - CHRU de Brest
City
Brest Cedex
State/Province
Bretagne
ZIP/Postal Code
29609
Country
France
Facility Name
Hôpital Privé des Côtes d'Armor - Service oncologie
City
Plérin
State/Province
Bretagne
ZIP/Postal Code
22190
Country
France
Facility Name
University Hospital of Besançon
City
Besançon cedex
State/Province
Franche-Comté
ZIP/Postal Code
25033
Country
France
Facility Name
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital
City
Toulouse cedex 9
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35042
Country
France
Facility Name
ICM Val d'Aurelle
City
Montpellier Cedex 5
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Privé Jean Mermoz
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69008
Country
France
Facility Name
Hospital of Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Facility Name
Institut de Cancérologie de l'Ouest
City
Angers Cedex 02
ZIP/Postal Code
49055
Country
France
Facility Name
ICO
City
Angers Cedex 2
ZIP/Postal Code
49055
Country
France
Facility Name
Pitié Salpetriere - Gastroenterology
City
Paris cedex 13
State/Province
Île-de-France
ZIP/Postal Code
75651
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Île-de-France
ZIP/Postal Code
94805
Country
France
Facility Name
LTD Acad.F.Todua Medical Center -Research Institute of Clinical Medicine
City
Melkadze
State/Province
Tamar
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Multiprofile Clinic Consilium Medulla LTD
City
Tbilisi
ZIP/Postal Code
186
Country
Georgia
Facility Name
Scientific Research Center of Oncology LTD
City
Tbilisi
ZIP/Postal Code
186
Country
Georgia
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
City
Szolnok
State/Province
Jász-Nagykun-Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
City
Nyíregyháza
State/Province
Szabolcs-Szatmár-Bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pécsi Tudományegyetem Klinikai Központ
City
Pécs
ZIP/Postal Code
H-7624
Country
Hungary
Facility Name
Aichi Cancer Center Hospital - Clinical Oncology
City
Nagoya
State/Province
Aiti [Aichi]
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Kindai University Hospital
City
Kawakami
State/Province
Histao
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Japan Community Health Care Organization (JCHO) Kyushu Hospital - Hospital
City
Kitakyushu-shi
State/Province
Hukuoka [Fukuoka]
ZIP/Postal Code
806-8501
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Osaka University Hospital - Medical Oncology
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo Ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kansai Medical University Hospital
City
Hirakata
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Hyogo College of Medicine College Hospital
City
Hyōgo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Osaka International Cancer Institute - Medical Oncology
City
Osaka-shi
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
National Hospital Organization - Osaka National Hospital
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaki Citizen Hospital
City
Osaka
ZIP/Postal Code
989-6183
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Takatsuki
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya
ZIP/Postal Code
3200-834
Country
Japan
Facility Name
Salve Medica
City
Łódź
State/Province
Lódzkie
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Mazowiecki Szpital Onkologiczny
City
Wieliszew
State/Province
Mazowieckie
ZIP/Postal Code
05-135
Country
Poland
Facility Name
Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi
City
Brzozow
State/Province
Podkarpackie
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o.
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Med Life
City
Bucuresti
ZIP/Postal Code
03748
Country
Romania
Facility Name
Gral Medical
City
Bucuresti
ZIP/Postal Code
31422
Country
Romania
Facility Name
Medisprof
City
Cluj-Napoca
ZIP/Postal Code
400641
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta
City
Constanţa
ZIP/Postal Code
900591
Country
Romania
Facility Name
Oncolab
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Facility Name
Guz Clinical Oncology Dispensary #1
City
Krasnodar
State/Province
Krasnodarskiy Kray
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Guz Clinical Oncology Dispensary #1
City
Krasnodar
ZIP/Postal Code
35004
Country
Russian Federation
Facility Name
Main Military Hospital n.a. Burdenko
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
GUZ Perm Regional Oncology Dispensary
City
Perm
ZIP/Postal Code
614066
Country
Russian Federation
Facility Name
N.N. Petrov Research Institute of Oncology
City
Saint Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
GBOU VPO NorthWestern State Medical University n.a. I.I. Mec
City
Saint Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Samara Regional Clinical Oncology Dispensary :
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
GBUZ "Regional clinical oncologic dispensary of Volgograd"
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
National Cancer Centre
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Raffles Hospital
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
188770
Country
Singapore
Facility Name
Tan Tock Seng Hospital - Oncology
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169210
Country
Singapore
Facility Name
Institut Catalá d´Oncología (I.C.O.)
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Alcorcón
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramón Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Madrid Norte Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena.
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Clínico de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universtiario Miguel Servet.
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Chi Mei Medical Center
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
Tri-Service General Hospital - Neihu Branch - Hematology
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
NHS - Guy's & St Thomas' Hospital - Medical Oncology
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute UK
City
London
State/Province
Greater London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Berkshire Hospital
City
London
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Guy's and St Thomas NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
East and North Hertfordshire NHS Trust
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Mount Vernon Hospital
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Peterborough And Stamford Hospitals - Haematology & Oncology
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
Peterborough And Stamford Hospitals
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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