Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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.
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.
Study 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
Primary outcome measure(s)
- Part A: Incidence, duration, and severity of adverse events (AEs) — Up to 30 days from study discontinuation
As assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (or the most current version). - Part B: PFS by BICR — From first study drug administration until the date of first documented progression assessed by BICR or date of death from any cause, whichever came first, assessed up to 24 months
Progression-free survival (PFS) by BICR: PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or date of death due to any cause, whichever is earlier.
Trial sites (87)
| Facility | City | Region | Status |
|---|---|---|---|
| UCLA Medical Center | Santa Monica | California | |
| Stanford Cancer Center | Stanford | California | |
| The University of Kansas Cancer Center | Westwood, Los Angeles | California | |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | |
| The University of Chicago Hospitals | Chicago | Illinois | |
| UMass Memorial Medical Center | Worcester | Massachusetts | |
| University of Michigan | Ann Arbor | Michigan | |
| Henry Ford | Detroit | Michigan | |
| University of Minnesota- Masonic Cancer Center, M Health Fairview | Minneapolis | Minnesota | |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | |
| Messino Cancer Centers | Asheville | North Carolina | |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | |
| Tennessee Oncology- Nashville | Nashville | Tennessee | |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | |
| University of Texas Southwestern Medical Center | Dallas | Texas | |
| Texas Oncology-Sammons Cancer Center | Dallas | Texas | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | |
| University of Virginia Cancer Center | Charlottesville | Virginia | |
| Medical College of Wisconsin | Milwaukee | Wisconsin | |
| Ordensklinikum Linz GmbH | Linz | Austria | |
| Landesklinikum Wiener Neustadt | Wiener Neustadt | Austria | |
| Universitair Ziekenhuis Antwerpen | Antwerp | Belgium | |
| Universitair Ziekenhuis Gent | Ghent | Belgium | |
| Universitair Ziekenhuis Leuven | Leuven | Belgium | |
| Institut Sainte Catherine - Institut du Cancer Avignon Provence | Avignon | France | |
| Centre Hospitalier Régional Universitaire de Besançon | Besançon | France | |
| Hopital Beaujon | Clichy | France | |
| Hopital Franco-Britannique - Fondation Cognacq-Jay | Levallois-Perret | France | |
| Clinique de la Sauvegarde | Lyon | France | |
| Centre Hospitalier Universitaire de Montpellier | Montpellier | France | |
| Hopital Saint Antoine | Paris | France | |
| Institut de Cancerologie Gustave Roussy | Villejuif | France | |
| Krebszentrum Reutlingen | Baden | Germany | |
| Krankenhaus Nordwest gGmbH | Frankfurt | Germany | |
| Asklepios Klinik Altona | Hamburg | Germany | |
| Medizinische Hochschule Hannover | Hanover | Germany | |
| Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT) | Heidelberg | Germany | |
| Ludwig-Maximilians-Universität München Kum | München | Germany | |
| Clinica Oncologica, Ospedali Riuniti Umberto 1 | Ancona | Italy | |
| Candiolo Cancer Institute - FPO IRCCS | Candiolo | Italy |
+ 47 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05948475 on ClinicalTrials.gov ↗ ← All trials in Italy