A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib VS Physician's Choice in Subjects With FGFR-altered, Chemotherapy- and FGFR Inhibitor-Cholangiocarcinoma
Status: Recruiting
Location: See all (87) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease.
• Documentation of FGFR2 fusion/rearrangement gene status
• Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor.
Locations
United States
California
UCLA Medical Center
RECRUITING
Santa Monica
Stanford Cancer Center
RECRUITING
Stanford
The University of Kansas Cancer Center
RECRUITING
Westwood, Los Angeles
Florida
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Illinois
The University of Chicago Hospitals
RECRUITING
Chicago
Massachusetts
UMass Memorial Medical Center
NOT_YET_RECRUITING
Worcester
Michigan
University of Michigan
NOT_YET_RECRUITING
Ann Arbor
Henry Ford
NOT_YET_RECRUITING
Detroit
Minnesota
University of Minnesota- Masonic Cancer Center, M Health Fairview
NOT_YET_RECRUITING
Minneapolis
North Carolina
Messino Cancer Centers
RECRUITING
Asheville
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Tennessee
Tennessee Oncology- Nashville
RECRUITING
Nashville
Vanderbilt-Ingram Cancer Center
RECRUITING
Nashville
Texas
Texas Oncology-Sammons Cancer Center
NOT_YET_RECRUITING
Dallas
University of Texas Southwestern Medical Center
NOT_YET_RECRUITING
Dallas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Virginia
University of Virginia Cancer Center
RECRUITING
Charlottesville
Wisconsin
Medical College of Wisconsin
NOT_YET_RECRUITING
Milwaukee
Other Locations
Austria
Ordensklinikum Linz GmbH
RECRUITING
Linz
Landesklinikum Wiener Neustadt
NOT_YET_RECRUITING
Wiener Neustadt
Belgium
Universitair Ziekenhuis Antwerpen
NOT_YET_RECRUITING
Antwerp
Universitair Ziekenhuis Gent
NOT_YET_RECRUITING
Ghent
Universitair Ziekenhuis Leuven
NOT_YET_RECRUITING
Leuven
France
Institut Sainte Catherine - Institut du Cancer Avignon Provence
NOT_YET_RECRUITING
Avignon
Centre Hospitalier Régional Universitaire de Besançon
NOT_YET_RECRUITING
Besançon
Hopital Beaujon
NOT_YET_RECRUITING
Clichy
Hopital Franco-Britannique - Fondation Cognacq-Jay
NOT_YET_RECRUITING
Levallois-perret
Clinique de la Sauvegarde
NOT_YET_RECRUITING
Lyon
Centre Hospitalier Universitaire de Montpellier
NOT_YET_RECRUITING
Montpellier
Hopital Saint Antoine
NOT_YET_RECRUITING
Paris
Institut de Cancerologie Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Germany
Krebszentrum Reutlingen
RECRUITING
Baden
Krankenhaus Nordwest gGmbH
RECRUITING
Frankfurt
Asklepios Klinik Altona
NOT_YET_RECRUITING
Hamburg
Medizinische Hochschule Hannover
NOT_YET_RECRUITING
Hanover
Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT)
RECRUITING
Heidelberg
Ludwig-Maximilians-Universität München Kum
NOT_YET_RECRUITING
München
Italy
Clinica Oncologica, Ospedali Riuniti Umberto 1
RECRUITING
Ancona
Candiolo Cancer Institute - FPO IRCCS
NOT_YET_RECRUITING
Candiolo
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
RECRUITING
Meldola
ASST Grande Ospedale Metropolitano Niguard
NOT_YET_RECRUITING
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
NOT_YET_RECRUITING
Milan
Istituto Europeo di Oncologia IRCCS
NOT_YET_RECRUITING
Milan
Azienda Ospedaliera Universitaria Luigi Vanvitelli
NOT_YET_RECRUITING
Naples
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
RECRUITING
Naples
Azienda Ospedaliera Universitaria di Parma
NOT_YET_RECRUITING
Parma
Azienda Ospedaliero-Universitaria Pisana
NOT_YET_RECRUITING
Pisa
Humanitas Research Hospital
RECRUITING
Rozzano
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
NOT_YET_RECRUITING
Siena
AOUI Verona - Ospedale Borgo Roma
RECRUITING
Verona
Netherlands
Amsterdam UMC, location AMC
NOT_YET_RECRUITING
Amsterdam
Poland
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
NOT_YET_RECRUITING
Warsaw
Portugal
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
NOT_YET_RECRUITING
Lisbon
Fundação Champalimaud
NOT_YET_RECRUITING
Lisbon
Republic of Korea
Dong-A University Hospital
RECRUITING
Busan
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Kyungpook National University Hospital
RECRUITING
Daegu
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun
Gachon University Gil Medical Center
RECRUITING
Incheon
Gyeongsang National University Hospital
RECRUITING
Jinju
CHA Bundang Medical Center
RECRUITING
Seongnam-si
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Yonsei University Health System - Severance Hospital
RECRUITING
Seoul
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d´Hebron
RECRUITING
Barcelona
Hospital Universitario Reina Sofa
RECRUITING
Córdoba
Clinica Universidad de Navarra
RECRUITING
Madrid
HM Hospital Universitario Madrid Sanchinarro - CIOCC
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario 12 de octubre
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Clinica Universidad de Navarra
RECRUITING
Pamplona
Hospital Clinico Universitario de Santiago de Compostela
NOT_YET_RECRUITING
Santiago De Compostela
Hospital Universitario Miguel Servet
NOT_YET_RECRUITING
Zaragoza
Taiwan
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
NOT_YET_RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
Royal Marsden Hospital NHS
NOT_YET_RECRUITING
London
UCG-1st floor central
NOT_YET_RECRUITING
London
The Christie NHS Foundation Trust - Christie Hospital
NOT_YET_RECRUITING
Manchester
Nottingham University Hospitals NHS Trust
NOT_YET_RECRUITING
Nottingham
Contact Information
Primary
Jean Fan, MD
fan_jean@transtherabio.com
86-25-86901107
Backup
Hui Wang
wang_hui@transtherabio.com
86-25-86901159
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2026-08
Participants
Target number of participants: 200
Treatments
Experimental: Tinengotinib 8 mg QD
Tinengotinib will be administered in 28-day cycles.
Experimental: Tinengotinib 10 mg QD
Tinengotinib will be administered in 28-day cycles.
Active_comparator: Physician's Choice
Physician's Choice treatments include FOLFOX or FOLFIRI
Related Therapeutic Areas
Sponsors
Leads: TransThera Sciences (Nanjing), Inc.