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Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

Primary Purpose

Advanced Cholangiocarcinoma, FGFR2 Gene Mutation

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BGJ398
Gemcitabine
Cisplatin
Sponsored by
QED Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cholangiocarcinoma focused on measuring cholangiocarcinoma, unresectable cholangiocarcinoma, metastatic cholangiocarcinoma, fibroblast growth factor receptor inhibitor, FGFR2, FGFR2 gene fusions/translocations, BGJ398

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically or cytologically confirmed unresectable locally advanced or metastatic cholangiocarcinoma. Participants with gallbladder cancer or ampulla of Vater carcinoma are not eligible
  • 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:

  • Received treatment with any systemic anti-cancer therapy for unresectable locally advanced or metastatic cholangiocarcinoma, with following exceptions

    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

Sites / Locations

  • Banner MD Anderson Cancer Center
  • University of Arizona
  • University of Arkansas for Medical Sciences
  • St. Joseph Heritage Healthcare
  • USC Norris Cancer Center
  • University of California Los Angeles
  • Florida Hospital Medical Group
  • UF Health Cancer Center at Orlando Health
  • Northwestern Memorial Hospital
  • University Medical Center - New Orleans
  • Frederick Regional Healthcare Systems/James M. Stockman Cancer Institute
  • Massachusetts General Hospital
  • Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center
  • Cancer and Hematology Centers of Western Michigan
  • William Beaumont Hospital
  • NYU Langone Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Levine Cancer Institute - Charlotte
  • University of Cincinnati Medical Center
  • Ohio State University Comprehensive Cancer Center
  • Charleston Oncology
  • Parkland Health and Hospital System
  • University of Texas Southwestern Medical Center
  • University of Texas MD Anderson Cancer Center
  • Baylor College of Medicine
  • Chris O'Brien Lifehouse Hospital
  • Blacktown Hospital
  • Royal Adelaide Hospital
  • Monash Medical Centre
  • Peninsula & South Eastern Haematology and Oncology Group
  • St John of God Hospital Subiaco
  • Cliniques Universitaires Saint-Luc
  • Grand Hopital de Charleroi
  • Universitair Ziekenhuis Antwerpen
  • Cross Cancer Institute
  • Ottawa Hospital
  • St. Josephs Health Centre
  • Jewish General Hospital
  • Peking University People's Hospital
  • Beijing Cancer Hospital
  • Peking University Third Hospital
  • Hunan Cancer Hospital
  • Guangzhou First People's Hospital
  • Hubei Cancer Hospital
  • Liaoning Cancer Hospital & Institute
  • The First Affiliated Hospital, Sun Yat-sen University
  • Hopital Henri Mondor
  • CHRU Dijon
  • Centre Georges-Francois Leclerc
  • Hopital Claude Huriez Rue Michel Polonovski (CHRU) Lille
  • Groupement Hospitalier Edouard Herriot
  • Hopital Nord Franche-Comte
  • Groupe Hospitalier Archet I Et II
  • Hopital Cochin
  • Hôpital Saint Antoine
  • L'Institut Mutualiste Montsouris
  • Universitätsklinikum Tübingen
  • Klinikum rechts der Isar der Technischen Universität München
  • Klinikum Dortmund gGmbH
  • University Clinic Heidelberg
  • Azienda Socio Sanitaria Territoriale di Cremona (ASST)
  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • ASST Grande Ospedale Metropolitano Niguarda
  • Istituto Oncologico Veneto - I.R.C.C.S.
  • Policlinico Universitario Campus Biomedico Di Roma
  • Pusan National University Hospital
  • Seoul National University Bundang Hospital
  • SMG - SNU Boramae Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • Severance Hospital Yonsei University Health System
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Ajou University Hospital
  • Hospital Beatriz Angelo
  • Hospital Garcia de Orta
  • Centro Hospitalar E Universitário de Coimbra EPE
  • Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE
  • Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
  • Hospital CUF Descobertas
  • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
  • Centro Hospitalar do Porto - Hospital de Santo António
  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
  • Centro Hospitalar de São João, E.P.E.
  • Hospital Oncologico, Puerto Rico Medical Center
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Miguel Servet
  • Complejo Asistencial Universitario de Salamanca - Hospital Clinico
  • Hospital Universitario Germans Trias i Pujol
  • Instituto Catalan de Oncologio ICO I'Hospitalet
  • Hospital Universitario Vall d'Hebrón - PPDS
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitario HM Sanchinarro - CIOCC
  • Hospital Universitari i Politecnic La Fe de Valencia
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital - YunLin Branch
  • Chang Gung Memorial Hospital - Kaohsiung
  • China Medical University Hospital
  • Chi Mei Hospital, Liouying
  • Taipei Veterans General Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital, Linkou
  • Songklanagarind Hospital, Prince of Songkla University
  • Chulalongkorn University
  • Ramathibodi Hospital Mahidol University
  • Maharaj Nakorn Chiang Mai Chiang Mai University
  • Srinagarind Hospital
  • Naresuan University
  • Nottingham City Hospital
  • Royal Marsden Hospital
  • The Clatterbridge Cancer Centre NHS Foundation Trust
  • Guys Hospital
  • The Christie NHS Foundation Trust - PPDS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Infigratinib (BGJ398) 125 mg

Gemcitabine + Cisplatin

Arm Description

Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.

Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib if certain criteria are met.

Outcomes

Primary Outcome Measures

Progression-free survival (central imaging assessment)
Defined as the time from randomization until date of disease progression by blinded independent central imaging assessment (Response Evaluation Criteria in Solid Tumors [RECIST] v. 1.1) or death, whichever occurs first.

Secondary Outcome Measures

Overall survival in participants treated with infigratinib versus gemcitabine with cisplatin
Defined as time from date of randomization until death due to any cause
Investigator assessed progression free survival in participants treated with infigratinib compared to gemcitabine and cisplatin
Defined as the time from randomization until date of disease progression by site investigator (RECIST v1.1) or death, whichever occurs first.
Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by overall response rate (ORR) determined by blinded independent central assessment and the investigator.
Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by best overall response (BOR) determined by blinded independent central assessment and the investigator.
Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by duration of response (DOR) determined by blinded independent central assessment and the investigator.
Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by disease control rate (PR+CR+SD) determined by blinded independent central assessment and the investigator.
Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability of infigratinib.

Full Information

First Posted
December 10, 2018
Last Updated
March 29, 2023
Sponsor
QED Therapeutics, Inc.
Collaborators
Helsinn Healthcare SA
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1. Study Identification

Unique Protocol Identification Number
NCT03773302
Brief Title
Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
Official Title
A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
The sponsor has decided to close the study due to the discontinuation of infigratinib development in oncology within the sponsor's territory. The discontinuation of the study was not due to safety issues.
Study Start Date
December 27, 2019 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
QED Therapeutics, Inc.
Collaborators
Helsinn Healthcare SA

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
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
Keywords
cholangiocarcinoma, unresectable cholangiocarcinoma, metastatic cholangiocarcinoma, fibroblast growth factor receptor inhibitor, FGFR2, FGFR2 gene fusions/translocations, BGJ398

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, Open Label, 2:1 Randomized, Controlled Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infigratinib (BGJ398) 125 mg
Arm Type
Experimental
Arm Description
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
Arm Title
Gemcitabine + Cisplatin
Arm Type
Active Comparator
Arm Description
Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib if certain criteria are met.
Intervention Type
Drug
Intervention Name(s)
BGJ398
Other Intervention Name(s)
Infigratinib
Intervention Description
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival (central imaging assessment)
Description
Defined as the time from randomization until date of disease progression by blinded independent central imaging assessment (Response Evaluation Criteria in Solid Tumors [RECIST] v. 1.1) or death, whichever occurs first.
Time Frame
Approximately 11 months on average
Secondary Outcome Measure Information:
Title
Overall survival in participants treated with infigratinib versus gemcitabine with cisplatin
Description
Defined as time from date of randomization until death due to any cause
Time Frame
Approximately 15 months on average
Title
Investigator assessed progression free survival in participants treated with infigratinib compared to gemcitabine and cisplatin
Description
Defined as the time from randomization until date of disease progression by site investigator (RECIST v1.1) or death, whichever occurs first.
Time Frame
Approximately 10 months on average
Title
Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by overall response rate (ORR) determined by blinded independent central assessment and the investigator.
Time Frame
Approximately 10 months on average
Title
Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by best overall response (BOR) determined by blinded independent central assessment and the investigator.
Time Frame
Approximately 10 months on average
Title
Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by duration of response (DOR) determined by blinded independent central assessment and the investigator.
Time Frame
Approximately 10 months on average
Title
Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by disease control rate (PR+CR+SD) determined by blinded independent central assessment and the investigator.
Time Frame
Approximately 10 months on average
Title
Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability of infigratinib.
Time Frame
Approximately from baseline to last dose date of study treatment + 30 days, approximately 12 months on average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed unresectable locally advanced or metastatic cholangiocarcinoma. Participants with gallbladder cancer or ampulla of Vater carcinoma are not eligible 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: Received treatment with any systemic anti-cancer therapy for unresectable locally advanced or metastatic cholangiocarcinoma, with following exceptions Prior neoadjuvant or adjuvant therapy is permitted if completed > 6 months after the last dose of neoadjuvant or adjuvant therapy. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development
Organizational Affiliation
QED Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
USC Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Florida Hospital Medical Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
UF Health Cancer Center at Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University Medical Center - New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Frederick Regional Healthcare Systems/James M. Stockman Cancer Institute
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Cancer and Hematology Centers of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Levine Cancer Institute - Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Facility Name
Charleston Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Parkland Health and Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75343
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77096
Country
United States
Facility Name
Chris O'Brien Lifehouse Hospital
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
Blacktown Hospital
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Monash Medical Centre
City
Bentleigh East
State/Province
Victoria
Country
Australia
Facility Name
Peninsula & South Eastern Haematology and Oncology Group
City
Frankston
State/Province
Victoria
Country
Australia
Facility Name
St John of God Hospital Subiaco
City
Subiaco
State/Province
Western Australia
Country
Australia
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
State/Province
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hopital de Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
St. Josephs Health Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100033
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
ZIP/Postal Code
410006
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Hubei Cancer Hospital
City
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
ZIP/Postal Code
110042
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Zhongshan
ZIP/Postal Code
510060
Country
China
Facility Name
Hopital Henri Mondor
City
Créteil
State/Province
Val-de-Marne
ZIP/Postal Code
94000
Country
France
Facility Name
CHRU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Centre Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital Claude Huriez Rue Michel Polonovski (CHRU) Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Groupement Hospitalier Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hopital Nord Franche-Comte
City
Montbéliard
ZIP/Postal Code
25200
Country
France
Facility Name
Groupe Hospitalier Archet I Et II
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
L'Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität München
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum Dortmund gGmbH
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
University Clinic Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Azienda Socio Sanitaria Territoriale di Cremona (ASST)
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Istituto Oncologico Veneto - I.R.C.C.S.
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico Di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Facility Name
SMG - SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon-si
Country
Korea, Republic of
Facility Name
Hospital Beatriz Angelo
City
Loures
State/Province
Lisboa
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Hospital Garcia de Orta
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Centro Hospitalar E Universitário de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital CUF Descobertas
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Facility Name
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
City
Lisbon
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Centro Hospitalar do Porto - Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Centro Hospitalar de São João, E.P.E.
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Hospital Oncologico, Puerto Rico Medical Center
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
State/Province
Aragon
ZIP/Postal Code
50009
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca - Hospital Clinico
City
Salamanca
State/Province
Castilla Y Leon
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Cataluna
ZIP/Postal Code
08916
Country
Spain
Facility Name
Instituto Catalan de Oncologio ICO I'Hospitalet
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebrón - PPDS
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro - CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
National Cheng Kung University Hospital
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital - YunLin Branch
City
Huwei
ZIP/Postal Code
632
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Kaohsiung
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Chi Mei Hospital, Liouying
City
Tainan
ZIP/Postal Code
73657
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Songklanagarind Hospital, Prince of Songkla University
City
Hat Yai
State/Province
Songkla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital Mahidol University
City
Bangkok
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
Country
Thailand
Facility Name
Naresuan University
City
Phitsanulok
Country
Thailand
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Bebington
State/Province
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust - PPDS
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32580579
Citation
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.
Results Reference
derived

Learn more about this trial

Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

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