Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 20, 2023

Primary Completion Date

May 31, 2026

Study Completion Date

August 31, 2026

Conditions
Cholangiocarcinoma
Interventions
DRUG

Tinengotinib 8 mg

Subjects randomized to receive tinengotinib will receive a starting dose of either 8 mg QD., self-administered orally QD in 28-day cycles.

DRUG

Tinengotinib 10 mg

Subjects randomized to receive tinengotinib will receive a starting dose of either10 mg QD., self-administered orally QD in 28-day cycles.

DRUG

Physician's Choice

For subjects receiving FOLFOX or FOLFIRI, the subject will receive treatment every two weeks, with two administrations per each 28-day cycle.

Trial Locations (87)

10002

RECRUITING

National Taiwan University Hospital, Taipei

10060

NOT_YET_RECRUITING

Candiolo Cancer Institute - FPO IRCCS, Candiolo

11217

RECRUITING

Taipei Veterans General Hospital, Taipei

13496

RECRUITING

CHA Bundang Medical Center, Seongnam-si

14263

RECRUITING

Roswell Park Comprehensive Cancer Center, Buffalo

21565

RECRUITING

Gachon University Gil Medical Center, Incheon

22908

RECRUITING

University of Virginia Cancer Center, Charlottesville

28806

RECRUITING

Messino Cancer Centers, Asheville

33140

RECRUITING

Mount Sinai Comprehensive Cancer Center, Miami Beach

37203

RECRUITING

Tennessee Oncology- Nashville, Nashville

RECRUITING

Vanderbilt-Ingram Cancer Center, Nashville

40705

NOT_YET_RECRUITING

Taichung Veterans General Hospital, Taichung

41944

RECRUITING

Kyungpook National University Hospital, Daegu

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

48103

NOT_YET_RECRUITING

University of Michigan, Ann Arbor

48108

RECRUITING

Inje University Haeundae Paik Hospital, Busan

48201

NOT_YET_RECRUITING

Henry Ford, Detroit

49201

RECRUITING

Dong-A University Hospital, Busan

52727

RECRUITING

Gyeongsang National University Hospital, Jinju

53202

NOT_YET_RECRUITING

Medical College of Wisconsin, Milwaukee

55455

NOT_YET_RECRUITING

University of Minnesota- Masonic Cancer Center, M Health Fairview, Minneapolis

58128

RECRUITING

Chonnam National University Hwasun Hospital, Hwasun

60601

RECRUITING

The University of Chicago Hospitals, Chicago

75201

NOT_YET_RECRUITING

University of Texas Southwestern Medical Center, Dallas

75246

NOT_YET_RECRUITING

Texas Oncology-Sammons Cancer Center, Dallas

77002

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

80756

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

90024

RECRUITING

The University of Kansas Cancer Center, Westwood, Los Angeles

90401

RECRUITING

UCLA Medical Center, Santa Monica

94305

RECRUITING

Stanford Cancer Center, Stanford

833401

RECRUITING

Chang Gung Memorial Hospital CGMH - Kaohsiung Branch, Kaohsiung City

01655

NOT_YET_RECRUITING

UMass Memorial Medical Center, Worcester

Unknown

RECRUITING

Ordensklinikum Linz GmbH, Linz

NOT_YET_RECRUITING

Landesklinikum Wiener Neustadt, Wiener Neustadt

NOT_YET_RECRUITING

Universitair Ziekenhuis Antwerpen, Antwerp

NOT_YET_RECRUITING

Universitair Ziekenhuis Gent, Ghent

NOT_YET_RECRUITING

Universitair Ziekenhuis Leuven, Leuven

NOT_YET_RECRUITING

Institut Sainte Catherine - Institut du Cancer Avignon Provence, Avignon

NOT_YET_RECRUITING

Centre Hospitalier Régional Universitaire de Besançon, Besançon

NOT_YET_RECRUITING

Hopital Beaujon, Clichy

NOT_YET_RECRUITING

Hopital Franco-Britannique - Fondation Cognacq-Jay, Levallois-Perret

NOT_YET_RECRUITING

Clinique de la Sauvegarde, Lyon

NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Montpellier, Montpellier

NOT_YET_RECRUITING

Hopital Saint Antoine, Paris

NOT_YET_RECRUITING

Institut de Cancerologie Gustave Roussy, Villejuif

RECRUITING

Krebszentrum Reutlingen, Baden

RECRUITING

Krankenhaus Nordwest gGmbH, Frankfurt

NOT_YET_RECRUITING

Asklepios Klinik Altona, Hamburg

NOT_YET_RECRUITING

Medizinische Hochschule Hannover, Hanover

RECRUITING

Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT), Heidelberg

NOT_YET_RECRUITING

Ludwig-Maximilians-Universität München Kum, München

RECRUITING

Clinica Oncologica, Ospedali Riuniti Umberto 1, Ancona

RECRUITING

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

NOT_YET_RECRUITING

Istituto Europeo di Oncologia IRCCS, Milan

NOT_YET_RECRUITING

ASST Grande Ospedale Metropolitano Niguard, Milan

NOT_YET_RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli, Napoli

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli

NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria di Parma, Parma

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Pisana, Pisa

RECRUITING

Humanitas Research Hospital, Rozzano

NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte, Siena

RECRUITING

AOUI Verona - Ospedale Borgo Roma, Verona

NOT_YET_RECRUITING

Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Warsaw

NOT_YET_RECRUITING

Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria, Lisbon

NOT_YET_RECRUITING

Fundação Champalimaud, Lisbon

RECRUITING

Hospital Clínic de Barcelona, Barcelona

RECRUITING

Hospital Universitari Vall d´Hebron, Barcelona

RECRUITING

Hospital Universitario Reina Sofa, Córdoba

RECRUITING

Clinica Universidad de Navarra, Madrid

RECRUITING

HM Hospital Universitario Madrid Sanchinarro - CIOCC, Madrid

RECRUITING

Hospital General Universitario Gregorio Maranon, Madrid

RECRUITING

Hospital Universitario 12 de octubre, Madrid

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz, Madrid

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

RECRUITING

Clinica Universidad de Navarra, Pamplona

NOT_YET_RECRUITING

Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela

NOT_YET_RECRUITING

Hospital Universitario Miguel Servet, Zaragoza

NOT_YET_RECRUITING

Royal Marsden Hospital NHS, London

NOT_YET_RECRUITING

UCG-1st floor central, London

NOT_YET_RECRUITING

The Christie NHS Foundation Trust - Christie Hospital, Manchester

NOT_YET_RECRUITING

Nottingham University Hospitals NHS Trust, Nottingham

1105 AZ

NOT_YET_RECRUITING

Amsterdam UMC, location AMC, Amsterdam

03080

NOT_YET_RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Yonsei University Health System - Severance Hospital, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

08308

RECRUITING

Korea University Guro Hospital, Seoul

All Listed Sponsors
lead

TransThera Sciences (Nanjing), Inc.

INDUSTRY