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Trial record 1 of 1 for:    BGB-290-303
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Study of BGB-290 or Placebo in Patients With Advanced or Inoperable Gastric Cancer

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ClinicalTrials.gov Identifier: NCT03427814
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
This study will enroll subjects with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A subjects will receive BGB-290; in Arm B subjects will receive placebo. The purpose of this study is to show that BGB-290 (versus placebo) will improve progression-free survival (PFS) in subjects with advanced or inoperable gastric cancer.

Condition or disease Intervention/treatment Phase
Advanced or Inoperable Gastric Cancer Drug: BGB-290 Drug: Placebo Phase 3

Detailed Description:

This is a double-blind, placebo controlled, randomized multicenter global phase 3 study comparing the efficacy and safety of single agent poly (ADP-ribose) polymerase (PARP) inhibitor BGB-290 to placebo as maintenance therapy in subjects with advanced gastric cancer who have responded to first line platinum based chemotherapy. Subjects 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.

Patients 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 patients without disease progression, survival status, and new anticancer therapy.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: PARALLEL 303: A Phase 3, 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
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Arm A
Approximately 270 subjects to receive BGB-290 orally.
Drug: BGB-290
60 mg PO BID
Other Name: pamiparib

Placebo Comparator: Arm B
Approximately 270 subjects to receive placebo orally.
Drug: Placebo
60 mg PO BID




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: From randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first up to 5 years ]
    The primary objective of this study is to compare progression free survival between treatment groups (BGB-290 versus placebo) as determined by blinded independent central review.


Secondary Outcome Measures :
  1. Overall survival between treatment groups (BGB-290 versus placebo) [ Time Frame: From time of randomization until date of death due to any cause assessed, up to 5 years ]
  2. Progression free survival between treatment groups determined by investigator assessment [ Time Frame: From randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first, up to 5 years ]
  3. Progression free survival on subsequent treatment (PFS2) [ Time Frame: From the time of randomization to second disease progression, or death from any cause, whichever is first, up to 5 years ]
  4. Time to second subsequent treatment [ Time Frame: From the time from randomization until the second subsequent anti-cancer therapy or death after next-line therapy, up to 5 years ]
  5. Objective response rate by investigator assessment [ Time Frame: From randomization to first documentation of disease progression assessed up to 5 years ]
  6. Duration of response by investigator assessment [ Time Frame: The time from the first documented confirmed response of CR or PR to PD or death due to any cause, whichever occurs first, up to 5 years ]
  7. Time to response by investigator assessment [ Time Frame: Defined as the time from randomization to the first documented confirmed response of CR or PR assessed up to 5 years ]
  8. Incidence, nature and severity of adverse events between treatment groups [ Time Frame: From time of randomization to approximately 30 days after end of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427814


Contacts
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Contact: Jeannie Hou, Senior Director 1 (877) 828-5568 clinicaltrials@beigene.com

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Locations
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United States, California
St Joseph Heritage Healthcare Recruiting
Santa Rosa, California, United States, 95403
United States, Florida
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Baptist Health Medical Group Oncology, LLC - Research Center Recruiting
Miami, Florida, United States, 33176
Florida Cancer Specialists - Hematology/Oncology Recruiting
West Palm Beach, Florida, United States, 33401
United States, Indiana
Goshen Center for Cancer Care Recruiting
Goshen, Indiana, United States, 46526
United States, Kansas
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40217
United States, North Carolina
Novant Health & Presbyterian Healthcare - Presbyterian Hospi Recruiting
Charlotte, North Carolina, United States, 28204-3193
United States, Oklahoma
Stephenson Cancer Center - Oncology Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health and Science University Knight Cancer Institute - Hematology Medical Oncology - Hematology Medical Oncology Recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
The Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center (VUMC) Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Renovatio Clincal Recruiting
The Woodlands, Texas, United States, 77090
Australia, New South Wales
Central Coast Local Health District Recruiting
Gosford, New South Wales, Australia, 2250
Australia, Victoria
Monash Health Recruiting
Clayton, Victoria, Australia, 3168
Northern Hospital Recruiting
Epping, Victoria, Australia, 3076
Ballarat Oncology and Haematology Services Recruiting
Wendouree, Victoria, Australia, 3355
Belgium
UZ Antwerpen Recruiting
Wilrijk, Antwerpen, Belgium, 2610
AZ Maria Middelares - Campus Maria Middelares Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
UZ Gent Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
University Hospitals Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology Recruiting
Brugge, West-Vlaanderen, Belgium, 8000
CHU de Liège - Domaine Universitaire du Sart Tilman Recruiting
Liège, Belgium, 4000
China, Anhui
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China, 230022
Anhui Medical University - The Second Hospital Recruiting
Hefei, Anhui, China, 230601
China, Beijing
Beijing Cancer Hospital - Digestive Tumor Medical Recruiting
Beijing, Beijing, China, 100142
China, Fujian
The First Affiliated Hospital of Xiamen University Recruiting
Xiamen, Fujian, China
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Nanfang Hospital Recruiting
Guangzhou, Guangdong, China, 510515
The Sixth Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College - Oncology Recruiting
Shantou, Guangdong, China, 515031
China, Heilongjiang
Harbin Medical University Cancer Hospital - Oncology Recruiting
Haerbin, Heilongjiang, China, 150081
China, Henan
The First Affiliated Hospital of Xinxiang Medical University Recruiting
Xinxiang, Henan, China, 453100
The first affiliated hospital of Zhengzhou University - Oncology - Oncology Recruiting
Zhengzhou, Henan, China, 450052
China, Jiangsu
The Second Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215000
The Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, Jiangsu, China
Northern Jiangsu people's hospital - Oncology Recruiting
Yangzhou, Jiangsu, China, 225001
China, Liaoning
Liaoning Cancer Hospital & Institute - Medical Oncology Recruiting
Shenyang, Liaoning, China
China, Shandong
The Affiliated Hospital Of Qingdao University Recruiting
Qingdao, Shandong, China
China, Shanghai
Zhongshan Hospital Fudan University Recruiting
Shanghai, Shanghai, China
China, Tianjin
Tianjin Cancer Hospital Recruiting
Tianjin, Tianjin, China
China, Zhejiang
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310016
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
The Second Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China
China
Sun Yat-sen University - Cancer Center (SYSUCC) Recruiting
Guangzhou, China, 510060
Nanjing Drum Tower Hospital Recruiting
Nanjing, China
France
CHU Nice - Hôpital de l'Archet 2 Recruiting
Nice Cedex 3, Alpes Maritimes, France, 06200
Contact    +33492035943      
Hôpital Morvan - CHRU de Brest Recruiting
Brest Cedex, Bretagne, France, 29609
Hôpital Privé des Côtes d'Armor - Service oncologie Recruiting
Plérin, Bretagne, France, 22190
University Hospital of Besançon Recruiting
Besançon cedex, Franche-Comté, France, 25033
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Recruiting
Toulouse cedex 9, Haute-Garonne, France, 31059
Centre Eugène Marquis Recruiting
Rennes, Ille-et-Vilaine, France, 35042
ICM Val d'Aurelle Recruiting
Montpellier Cedex 5, Languedoc-Roussillon, France, 34298
Hopital Privé Jean Mermoz Recruiting
Lyon, Rhône, France, 69008
Hospital of Poitiers Recruiting
Poitiers, Vienne, France, 86021
Institut de Cancérologie de l'Ouest Recruiting
Angers Cedex 02, France, 49055
ICO Recruiting
Angers Cedex 2, France, 49055
Pitié Salpetriere - Gastroenterology Recruiting
Paris cedex 13, Île-de-France, France, 75651
Institut Gustave Roussy Recruiting
Villejuif, Île-de-France, France, 94805
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint Recruiting
Szolnok, Jász-Nagykun-Szolnok, Hungary, 5004
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór Recruiting
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1083
Országos Onkológiai Intézet Recruiting
Budapest, Hungary, 1122
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1125
Debreceni Egyetem Klinikai Központ Recruiting
Debrecen, Hungary, 4032
Pécsi Tudományegyetem Klinikai Központ Recruiting
Pécs, Hungary, H-7624
Japan
Aichi Cancer Center Hospital - Clinical Oncology Recruiting
Nagoya, Aiti [Aichi], Japan, 464-8681
Japan Community Health Care Organization (JCHO) Kyushu Hospital - Hospital Recruiting
Kitakyushu-shi, Hukuoka [Fukuoka], Japan, 806-8501
St. Marianna University School of Medicine Hospital Recruiting
Kawasaki, Kanagawa, Japan, 216-8511
Osaka University Hospital - Medical Oncology Recruiting
Suita, Osaka, Japan, 565-0871
Osaka International Cancer Institute - Medical Oncology Recruiting
Osaka-shi, Japan, 537-8511
Poland
Salve Medica Recruiting
Łódź, Lódzkie, Poland, 93-513
Mazowiecki Szpital Onkologiczny Recruiting
Wieliszew, Mazowieckie, Poland, 05-135
Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi Recruiting
Brzozow, Podkarpackie, Poland, 36-200
Szpitale Pomorskie Sp. z o.o. Recruiting
Gdynia, Poland, 81-519
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli Recruiting
Lublin, Poland, 20-090
Clinical Research Center Sp. z o.o., Medic-R Sp. K. Recruiting
Poznan, Poland, 60-569
Russian Federation
Guz Clinical Oncology Dispensary #1 Recruiting
Krasnodar, Krasnodarskiy Kray, Russian Federation, 350040
GBUZ "Regional clinical oncologic dispensary of Volgograd" Recruiting
Volgograd, Russian Federation, 400138
Singapore
National Cancer Centre Recruiting
Singapore, Central Singapore, Singapore, 169610
Raffles Hospital Recruiting
Singapore, Central Singapore, Singapore, 188770
Tan Tock Seng Hospital - Oncology Recruiting
Singapore, Central Singapore, Singapore, 308433
Spain
Institut Catalá d´Oncología (I.C.O.) Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Universitario Fundación Jiménez Díaz Recruiting
Alcorcon, Madrid, Spain, 28040
Clínica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Hospital de La Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Hospital Universitario Vall d'Hebrón Recruiting
Barcelona, Spain, 08035
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: Montserrat Blanco Codesido         
Hospital Universitario Ramón Y Cajal Recruiting
Madrid, Spain, 28034
Hospital Madrid Norte Sanchinarro Recruiting
Madrid, Spain, 28050
Hospital Clínico de Valencia Recruiting
Valencia, Spain, 46010
Taiwan
Chi Mei Medical Center Recruiting
Tainan, Taiwan, 710
Tri-Service General Hospital - Neihu Branch - Hematology Recruiting
Taipei, Taiwan, 11490
United Kingdom
NHS - Guy's & St Thomas' Hospital - Medical Oncology Recruiting
London, Greater London, United Kingdom, SE1 9RT
Sarah Cannon Research Institute UK Recruiting
London, Greater London, United Kingdom, W1G 6AD
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Contact: Mark Bishton, MD         
Mount Vernon Hospital Recruiting
Northwood, United Kingdom, HA6 2RN
Peterborough And Stamford Hospitals - Haematology & Oncology Recruiting
Peterborough, United Kingdom, PE3 9GZ
Sponsors and Collaborators
BeiGene

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03427814     History of Changes
Other Study ID Numbers: BGB-290-303
2017-003493-13 ( EudraCT Number )
CTR20171664 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by BeiGene:
BGB-290-303
BGB-290
PARP inhibitor
Phase 3
maintenance therapy
gastric cancer
oral treatment
PARALLEL303
PARALLEL 303
PARALLEL
BGB290303
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases