Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
NCT ID: NCT03773302
Last Updated: 2024-05-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
48 participants
INTERVENTIONAL
2019-12-27
2023-03-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Infigratinib (BGJ398) 125 mg
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
BGJ398
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
Gemcitabine + Cisplatin
Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib if certain criteria are met.
Gemcitabine
Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
Cisplatin
Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
Interventions
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BGJ398
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
Gemcitabine
Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
Cisplatin
Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have written documentation of local laboratory or central laboratory determination of a known or likely activating FGFR2 fusion/rearrangement from a sample collected before randomization
* Have an archival tumor tissue sample available with sufficient tumor content for FGFR2 fusion/rearrangement molecular testing by the central laboratory. However, if an archival tumor tissue sample is not available, or does not meet requirements for central testing a newly obtained (before randomization) tumor biopsy may be submitted instead. If a prestudy written documentation of FGFR2 fusion/rearrangement in tumor tissue is available from the central laboratory, an additional tumor sample does not need to be submitted.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Are able to swallow and retain oral medication
* Are willingness to avoid pregnancy or father children
Exclusion Criteria
1. Prior neoadjuvant or adjuvant therapy is permitted if completed \> 6 months after the last dose of neoadjuvant or adjuvant therapy.
2. One cycle of gemcitabine-based chemotherapy for locally advanced or metastatic cholangiocarcinoma is permitted before randomization
* History of a liver transplant
* Received previously or currently is receiving treatment with a mitogen activated protein kinase kinase (MEK) or selective FGFR inhibitor
* Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
* Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc.
* History and/or current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification
* Current evidence of corneal or retinal disorder/keratopathy
* Receiving and continued treatment or are planning to receive agents or consuming foods that are known moderate or strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration
* Clinically significant or uncontrolled cardiac disease
* Recent (≤ 3 months prior to first dose of study drug) transient ischemic attack or stroke
* Severe hearing loss
* Severe neuropathy
* History of another primary malignancy within 3 years except adequately treated in-situ carcinoma of the cervix or non-melanoma skin cancer or other curatively treated malignancy that is not expected to require treatment
* Pregnant or breastfeeding
* Have known microsatellite instability-high (MSI-H) disease and the decision is made by the treating investigator that an alternative, non-study therapy is warranted according to standard of care.
* Have any known hypersensitivity to gemcitabine, cisplatin, calcium-lowering agents, infigratinib, or their excipients
* Have any contraindication to cisplatin or gemcitabine treatment according to local labeling or standard institutional practice.
* Have taken any Chinese herbal medicine or Chinese patent medicine treatments with anticancer activity within 14 days of the first dose of study drug.
* Have received a live vaccine within 30 days before the first dose of study drug or are planning to receive a live vaccine during participation in this study
18 Years
ALL
No
Sponsors
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Helsinn Healthcare SA
INDUSTRY
QED Therapeutics, Inc., a Bridgebio company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_DIRECTOR
QED Therapeutics
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of Arizona
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
St. Joseph Heritage Healthcare
Fullerton, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Florida Hospital Medical Group
Orlando, Florida, United States
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University Medical Center - New Orleans
New Orleans, Louisiana, United States
Frederick Regional Healthcare Systems/James M. Stockman Cancer Institute
Frederick, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
NYU Langone Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute - Charlotte
Charlotte, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Charleston Oncology
Charleston, South Carolina, United States
Parkland Health and Hospital System
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Chris O'Brien Lifehouse Hospital
Camperdown, New South Wales, Australia
Blacktown Hospital
Darlinghurst, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Bentleigh East, Victoria, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
St John of God Hospital Subiaco
Subiaco, Western Australia, Australia
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
Grand Hopital de Charleroi
Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
St. Josephs Health Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Peking University People's Hospital
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Hunan Cancer Hospital
Changsha, , China
Guangzhou First People's Hospital
Guangzhou, , China
Hubei Cancer Hospital
Hubei, , China
Liaoning Cancer Hospital & Institute
Shenyang, , China
The First Affiliated Hospital, Sun Yat-sen University
Zhongshan, , China
Hopital Henri Mondor
Créteil, Val-de-Marne, France
CHRU Dijon
Dijon, , France
Centre Georges-Francois Leclerc
Dijon, , France
Hopital Claude Huriez Rue Michel Polonovski (CHRU) Lille
Lille, , France
Groupement Hospitalier Edouard Herriot
Lyon, , France
Hopital Nord Franche-Comte
Montbéliard, , France
Groupe Hospitalier Archet I Et II
Nice, , France
Hopital Cochin
Paris, , France
Hôpital Saint Antoine
Paris, , France
L'Institut Mutualiste Montsouris
Paris, , France
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Klinikum rechts der Isar der Technischen Universität München
München, Bavaria, Germany
Klinikum Dortmund gGmbH
Dortmund, , Germany
University Clinic Heidelberg
Heidelberg, , Germany
Azienda Socio Sanitaria Territoriale di Cremona (ASST)
Cremona, , Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST
Meldola, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Istituto Oncologico Veneto - I.R.C.C.S.
Padua, , Italy
Policlinico Universitario Campus Biomedico Di Roma
Roma, , Italy
Hospital Beatriz Angelo
Loures, Lisbon District, Portugal
Hospital Garcia de Orta
Almada, , Portugal
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, , Portugal
Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE
Coimbra, , Portugal
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, , Portugal
Hospital CUF Descobertas
Lisbon, , Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Porto, , Portugal
Centro Hospitalar de São João, E.P.E.
Porto, , Portugal
Hospital Oncologico, Puerto Rico Medical Center
Rio Piedras, , Puerto Rico
Pusan National University Hospital
Pusan, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
SMG - SNU Boramae Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain
Complejo Asistencial Universitario de Salamanca - Hospital Clinico
Salamanca, Castille and León, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Catalonia, Spain
Instituto Catalan de Oncologio ICO I'Hospitalet
Barcelona, Catalonia, Spain
Hospital Universitario Vall d'Hebrón - PPDS
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario HM Sanchinarro - CIOCC
Madrid, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
National Cheng Kung University Hospital
Tainan City, Tainan, Taiwan
National Taiwan University Hospital - YunLin Branch
Huwei, , Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Chi Mei Hospital, Liouying
Tainan City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, , Taiwan
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand
Chulalongkorn University
Bangkok, , Thailand
Ramathibodi Hospital Mahidol University
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Chiang Mai University
Chiang Mai, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
Naresuan University
Phitsanulok, , Thailand
Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral, United Kingdom
Guys Hospital
London, , United Kingdom
The Christie NHS Foundation Trust - PPDS
Manchester, , United Kingdom
Countries
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References
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Makawita S, K Abou-Alfa G, Roychowdhury S, Sadeghi S, Borbath I, Goyal L, Cohn A, Lamarca A, Oh DY, Macarulla T, T Shroff R, Howland M, Li A, Cho T, Pande A, Javle M. Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF 301 trial. Future Oncol. 2020 Oct;16(30):2375-2384. doi: 10.2217/fon-2020-0299. Epub 2020 Jun 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-004004-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
QBGJ398-301
Identifier Type: -
Identifier Source: org_study_id
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