Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
NCT ID: NCT05948475
Last Updated: 2024-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2023-12-20
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tinengotinib 8 mg QD
Tinengotinib will be administered in 28-day cycles.
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 QD
Tinengotinib will be administered 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
Physician's Choice treatments include FOLFOX or FOLFIRI
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease.
3. Documentation of FGFR2 fusion/rearrangement gene status
4. Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor.
Exclusion Criteria
2. Subjects with known brain or central nervous system (CNS) metastases that have radiologically or clinically progressed in the 28 days prior to initiation of therapy. Subjects with asymptomatic brain/CNS metastases or treated brain/CNS metastases that have been clinically stable for 14 days on steroids without escalation of steroids are eligible for enrollment.
3. Subjects with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, including those that have previously undergone potentially curative therapy.
4. Subjects who have received prior systemic therapy or investigational study drug ≤ 5 half-lives or 14 days, whichever is shorter, prior to starting the study drug or who have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue/asthenia, and neuropathy due to trauma) from adverse events (AEs) of prior therapy.
5. Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval.
6. Subjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not recovered from AEs of prior therapy.
7. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening)
18 Years
ALL
No
Sponsors
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TransThera Sciences (Nanjing), Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Milind Javle, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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UCLA Medical Center
Santa Monica, California, United States
Stanford Cancer Center
Stanford, California, United States
The University of Kansas Cancer Center
Westwood, Los Angeles, California, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
The University of Chicago Hospitals
Chicago, Illinois, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford
Detroit, Michigan, United States
University of Minnesota- Masonic Cancer Center, M Health Fairview
Minneapolis, Minnesota, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Messino Cancer Centers
Asheville, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Tennessee Oncology- Nashville
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Oncology-Sammons Cancer Center
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
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
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
Istituto Europeo di Oncologia IRCCS
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguard
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Napoli, , Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, , Italy
Azienda Ospedaliera Universitaria di Parma
Parma, , Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, , Italy
Humanitas Research Hospital
Rozzano, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, , Italy
AOUI Verona - Ospedale Borgo Roma
Verona, , Italy
Amsterdam UMC, location AMC
Amsterdam, , Netherlands
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
Warsaw, , Poland
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
Lisbon, , Portugal
Fundação Champalimaud
Lisbon, , Portugal
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Dong-A University Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Health System - Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Universitari Vall d´Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofa
Córdoba, , Spain
Clinica Universidad de Navarra
Madrid, , Spain
HM Hospital Universitario Madrid Sanchinarro - CIOCC
Madrid, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario 12 de octubre
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Royal Marsden Hospital NHS
London, , United Kingdom
UCG-1st floor central
London, , United Kingdom
The Christie NHS Foundation Trust - Christie Hospital
Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Minseong Seon
Role: primary
Other Identifiers
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TT420C2308
Identifier Type: -
Identifier Source: org_study_id
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