Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)
NCT ID: NCT03834220
Last Updated: 2024-02-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
63 participants
INTERVENTIONAL
2019-03-22
2022-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Debio 1347 (Biliary Tract Cancer)
Participants with biliary tract cancer were included in this cohort to receive Debio 1347 80 milligrams (mg) tablets, orally, once daily (QD), from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 20 weeks).
Debio 1347
Debio 1347 oral tablets.
Cohort 2: Debio 1347 (Urothelial Cancer)
Participants with urothelial cancer were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 5.86 weeks).
Debio 1347
Debio 1347 oral tablets.
Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)
Participants with all other solid tumor histologies were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 8.14 weeks).
Debio 1347
Debio 1347 oral tablets.
Interventions
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Debio 1347
Debio 1347 oral tablets.
Eligibility Criteria
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Inclusion Criteria
* Radiographic progression on prior systemic therapy; prior localized therapy (i.e., radiation, ablation, embolization) is allowed provided radiographic progression out-of-field or in the treatment, field is shown
* Locally-advanced (unresectable) or metastatic disease harboring an FGFR1-3 gene fusion/rearrangement potentially leading to a functional FGFR aberrant protein, identified through local and/or central molecular assay
Exclusion Criteria
* History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes, lung nodules and asymptomatic vascular or cartilage/tendon calcifications
* Administration of any investigational agent within 2 weeks prior to initial dosing with Debio 1347 (3 weeks for immune checkpoint inhibitors)
18 Years
ALL
No
Sponsors
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Caris Life Sciences
INDUSTRY
Optimal Research (Just In Time sites)
UNKNOWN
Debiopharm International SA
INDUSTRY
Responsible Party
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Locations
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Ironwood Cancer & Research Centers - Scottsdale
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Moores UCSD Cancer Center
La Jolla, California, United States
University of California San Francisco
San Francisco, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Tulane University Cancer Center
New Orleans, Louisiana, United States
The John Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center
Middletown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center
Harrison, New York, United States
Memorial Sloan-Kettering Hospital
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
UC Health, LLC.
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, United States
CTCA Cancer Treatment Centers
Tulsa, Oklahoma, United States
West Penn - Allegheny Oncology Network
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Utah Hospitals & Clinics
Salt Lake City, Utah, United States
Fred Hutchinson/Seattle Care Alliance
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Southern Highlands Private Hospital
Bowral, , Australia
Peninsula and Southeast Oncology (PASO)
Frankston, , Australia
Linear Clinical Research, B Block Sir Charles Gairdner Hospital
Nedlands, , Australia
John Flynn Private Hospital
Tugun, , Australia
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, , Austria
Landesklinikum Wiener Neustadt
Wiener Neustadt, , Austria
Hospital de Caridade de Ijuí, Avenida David J Martins
Ijuí, , Brazil
Hospital de Clínicas de Porto Alegre
Rio Grande, , Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, , Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, Avenida Doutor Arnaldo
São Paulo, , Brazil
MHAT - Dobrich
Dobrich, , Bulgaria
Complex Oncological Center - Plovdiv, EOOD
Plovdiv, , Bulgaria
MHAT "Serdika", EOOD
Sofia, , Bulgaria
General Hospital Varazdin
Varaždin, , Croatia
University Hospital Centre, Sestre Milosrdnice
Zagreb, , Croatia
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Thomayerova nemocnice
Prague, , Czechia
Ålborg Universitets Hospital
Aalborg, , Denmark
Herlev Hospital
Herlev, , Denmark
Odense Universitetshospital
Odense, , Denmark
Docrates Syöpäsairaala
Helsinki, , Finland
Helsinki University Hospital
Helsinki, , Finland
ICO - Site Paul Papin
Angers, , France
CHU Bordeaux - Hôpital Saint André, Groupe Hospitalier Sud - Hôpital Haut-Lévêque
Bordeaux, , France
Centre Oscar Lambret
Lille, , France
Groupe Hospitalier Sud - Hôpital Haut Lévêque
Pessac, , France
ICO - Site René Gauducheau
Saint-Herblain, , France
Institut Gustave Roussy
Villejuif, , France
General Hospital of Athens Laiko
Athens, , Greece
General Hospital of Athens of Chest Diseases "SOTIRIA"
Athens, , Greece
General Hospital of Athens "Alexandra"
Athens, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
VU Medisch Centrum
Amsterdam, , Netherlands
Haga Ziekenhuis
The Hague, , Netherlands
Akershus University Hospital
Lørenskog, , Norway
Radiumhospitalet, Montebello
Oslo, , Norway
Cebu Doctors' University Hospital (CDUH), Research Office
Cebu City, , Philippines
Philippine General Hospital, Clinical Trial Unit Room 5, Medical Research Laboratory
Ermita, , Philippines
St. Luke's Medical Center, Human Cancer Biobank Research Center
Quezon City, , Philippines
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu
Poznan, , Poland
MTZ Clinical Research
Warsaw, , Poland
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
Warsaw, , Poland
S.C Delta Health Care S.R.L
Bucharest, , Romania
S.C Medisprof S.R.L.
Cluj-Napoca, , Romania
S.C Centrul de Oncologie Sf. Nectarie S.R.L.
Craiova, , Romania
S.C Oncocenter Oncologie Clinica S.R.L.
Timișoara, , Romania
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
Arkhangelsk, , Russia
TSBHI "Altai Territorial oncological dispensary"
Barnaul, , Russia
LLC Evimed
Chelyabinsk, , Russia
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow, , Russia
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk, , Russia
Tomsk Research Instutite of Oncology
Tomsk, , Russia
Singapore National Cancer Center (SNCC)
Singapore, , Singapore
Tan Tock Seng Hospital, Communicable Disease Centre
Singapore, , Singapore
Seoul National University Bundang Hospital, Department of Oncology Medical office
Gyeonggi-do, , South Korea
The Catholic University of Korea, St. Vincent's Hospital, CRC Room, 3F
Gyeonggi-do, , South Korea
Gachon University Gil Medical Center, CRC Room, 18F, Artificial intelligence hospital
Incheon, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital (SNUH)
Seoul, , South Korea
Ajou University Hospital, CRC room, Clinical Trial Center
Suwon, , South Korea
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Shuang Ho Hospital
New Taipei City, , Taiwan
Taichung Veterans General Hospital, The Radiation Oncology Department
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Medical University Hospital (TMUH)
Taipei, , Taiwan
Taipei Veterans General Hospital, Medical Science & Technology Building
Taipei, , Taiwan
Linkou Chang-Gung Memorial Hospital
Taoyuan District, , Taiwan
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
Dnipro, , Ukraine
SI V.T. Zaycev Institute of general & urgent surgery of National academy medical sciences of Ukraine, Department of purulent surgery
Kharkiv, , Ukraine
Communal Non-profit Enterprise Regional Center of Oncology
Kharkiv, , Ukraine
Ninewells Hospital
Dundee, , United Kingdom
Guy's Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
The Christie
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003584-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Debio 1347-201
Identifier Type: -
Identifier Source: org_study_id
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