Actively Recruiting
Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
Led by TransThera Sciences (Nanjing), Inc. · Updated on 2024-06-24
200
Participants Needed
87
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of signing informed consent.
- Histologically or cytologically confirmed cholangiocarcinoma or adenocarcinoma of biliary origin with unresectable or metastatic disease.
- Documentation of FGFR2 fusion or rearrangement gene status.
- Received at least one prior line of chemotherapy and exactly one FDA-approved FGFR inhibitor.
You will not qualify if you...
- Prior treatment with two or more FGFR inhibitors, approved or investigational.
- Known brain or central nervous system metastases that have progressed within 28 days before starting therapy.
- Having a known concurrent progressing malignancy requiring active treatment, except certain noninvasive or indolent cancers.
- Received prior systemic therapy or investigational drug within 5 half-lives or 14 days before starting study drug, or not recovered from prior therapy adverse events except tolerable alopecia, fatigue, or neuropathy.
- Concurrent anticancer therapy including chemotherapy, immunotherapy, or radiotherapy; hormone therapy allowed with sponsor approval.
- Received wide field radiotherapy within 4 weeks or limited field radiation for palliation within 2 weeks before starting study drug or not recovered from those adverse events.
- Uncontrolled hypertension (blood pressure ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite treatment).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 87 locations
1
UCLA Medical Center
Santa Monica, California, United States, 90401
Actively Recruiting
2
Stanford Cancer Center
Stanford, California, United States, 94305
Actively Recruiting
3
The University of Kansas Cancer Center
Westwood, Los Angeles, California, United States, 90024
Actively Recruiting
4
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
5
The University of Chicago Hospitals
Chicago, Illinois, United States, 60601
Actively Recruiting
6
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Not Yet Recruiting
7
University of Michigan
Ann Arbor, Michigan, United States, 48103
Not Yet Recruiting
8
Henry Ford
Detroit, Michigan, United States, 48201
Not Yet Recruiting
9
University of Minnesota- Masonic Cancer Center, M Health Fairview
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
10
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
11
Messino Cancer Centers
Asheville, North Carolina, United States, 28806
Actively Recruiting
12
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
13
Tennessee Oncology- Nashville
Nashville, Tennessee, United States, 37203
Actively Recruiting
14
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75201
Not Yet Recruiting
16
Texas Oncology-Sammons Cancer Center
Dallas, Texas, United States, 75246
Not Yet Recruiting
17
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77002
Actively Recruiting
18
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
19
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53202
Not Yet Recruiting
20
Ordensklinikum Linz GmbH
Linz, Austria
Actively Recruiting
21
Landesklinikum Wiener Neustadt
Wiener Neustadt, Austria
Not Yet Recruiting
22
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
Not Yet Recruiting
23
Universitair Ziekenhuis Gent
Ghent, Belgium
Not Yet Recruiting
24
Universitair Ziekenhuis Leuven
Leuven, Belgium
Not Yet Recruiting
25
Institut Sainte Catherine - Institut du Cancer Avignon Provence
Avignon, France
Not Yet Recruiting
26
Centre Hospitalier Régional Universitaire de Besançon
Besançon, France
Not Yet Recruiting
27
Hopital Beaujon
Clichy, France
Not Yet Recruiting
28
Hopital Franco-Britannique - Fondation Cognacq-Jay
Levallois-Perret, France
Not Yet Recruiting
29
Clinique de la Sauvegarde
Lyon, France
Not Yet Recruiting
30
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
Not Yet Recruiting
31
Hopital Saint Antoine
Paris, France
Not Yet Recruiting
32
Institut de Cancerologie Gustave Roussy
Villejuif, France
Not Yet Recruiting
33
Krebszentrum Reutlingen
Baden, Germany
Actively Recruiting
34
Krankenhaus Nordwest gGmbH
Frankfurt, Germany
Actively Recruiting
35
Asklepios Klinik Altona
Hamburg, Germany
Not Yet Recruiting
36
Medizinische Hochschule Hannover
Hanover, Germany
Not Yet Recruiting
37
Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT)
Heidelberg, Germany
Actively Recruiting
38
Ludwig-Maximilians-Universität München Kum
München, Germany
Not Yet Recruiting
39
Clinica Oncologica, Ospedali Riuniti Umberto 1
Ancona, Italy
Actively Recruiting
40
Candiolo Cancer Institute - FPO IRCCS
Candiolo, Italy, 10060
Not Yet Recruiting
41
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
Actively Recruiting
42
Istituto Europeo di Oncologia IRCCS
Milan, Italy
Not Yet Recruiting
43
ASST Grande Ospedale Metropolitano Niguard
Milan, Italy
Not Yet Recruiting
44
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Not Yet Recruiting
45
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, Italy
Not Yet Recruiting
46
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy
Actively Recruiting
47
Azienda Ospedaliera Universitaria di Parma
Parma, Italy
Not Yet Recruiting
48
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy
Not Yet Recruiting
49
Humanitas Research Hospital
Rozzano, Italy
Actively Recruiting
50
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, Italy
Not Yet Recruiting
51
AOUI Verona - Ospedale Borgo Roma
Verona, Italy
Actively Recruiting
52
Amsterdam UMC, location AMC
Amsterdam, Netherlands, 1105 AZ
Not Yet Recruiting
53
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
Warsaw, Poland
Not Yet Recruiting
54
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
Lisbon, Portugal
Not Yet Recruiting
55
Fundação Champalimaud
Lisbon, Portugal
Not Yet Recruiting
56
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 13496
Actively Recruiting
57
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea, 52727
Actively Recruiting
58
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea, 58128
Actively Recruiting
59
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
Actively Recruiting
60
Dong-A University Hospital
Busan, South Korea, 49201
Actively Recruiting
61
Kyungpook National University Hospital
Daegu, South Korea, 41944
Actively Recruiting
62
Gachon University Gil Medical Center
Incheon, South Korea, 21565
Actively Recruiting
63
Seoul National University Hospital
Seoul, South Korea, 03080
Not Yet Recruiting
64
Yonsei University Health System - Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
65
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
66
Korea University Guro Hospital
Seoul, South Korea, 08308
Actively Recruiting
67
Hospital Clínic de Barcelona
Barcelona, Spain
Actively Recruiting
68
Hospital Universitari Vall d´Hebron
Barcelona, Spain
Actively Recruiting
69
Hospital Universitario Reina Sofa
Córdoba, Spain
Actively Recruiting
70
Clinica Universidad de Navarra
Madrid, Spain
Actively Recruiting
71
HM Hospital Universitario Madrid Sanchinarro - CIOCC
Madrid, Spain
Actively Recruiting
72
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Actively Recruiting
73
Hospital Universitario 12 de octubre
Madrid, Spain
Actively Recruiting
74
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Actively Recruiting
75
Hospital Universitario Ramón y Cajal
Madrid, Spain
Actively Recruiting
76
Clinica Universidad de Navarra
Pamplona, Spain
Actively Recruiting
77
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Spain
Not Yet Recruiting
78
Hospital Universitario Miguel Servet
Zaragoza, Spain
Not Yet Recruiting
79
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
80
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
Kaohsiung City, Taiwan, 833401
Actively Recruiting
81
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Not Yet Recruiting
82
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
83
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
84
Royal Marsden Hospital NHS
London, United Kingdom
Not Yet Recruiting
85
UCG-1st floor central
London, United Kingdom
Not Yet Recruiting
86
The Christie NHS Foundation Trust - Christie Hospital
Manchester, United Kingdom
Not Yet Recruiting
87
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Not Yet Recruiting
Research Team
J
Jean Fan, MD
CONTACT
H
Hui Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here