Clinical trial NCT03834220: Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)
Official title: A Phase II Basket Study of the Oral Selective Pan-FGFR Inhibitor Debio 1347 in Subjects With Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Solid Tumor
Lead sponsor: Debiopharm International SA
Sponsor class: INDUSTRY
Collaborators: name: Caris Life Sciences
name: Optimal Research (Just In Time sites)
First posted: 2019-02-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the efficacy of Debio 1347 in terms of objective response rate (ORR) in participants with solid tumors harboring fibroblast growth factor receptor (FGFR)1-3 gene fusion/rearrangement.


Eligibility criteria: Inclusion Criteria:

* Cytologically or histologically confirmed advanced solid tumor
* 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 of hypersensitivity to any of the excipients in the Debio 1347 formulation
* 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)

Primary outcomes:
measure: Objective Response Rate (ORR) as Centrally Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria
timeFrame: Up to disease progression or end of study (up to 1 year and 9 months)
Secondary outcomes:
measure: Duration of Response (DOR) as Centrally Measured by Independent Review Committee (IRC)
timeFrame: Up to disease progression or end of study (up to 2 years and 9 months)
measure: Disease Control Rate (DCR) as Centrally Measured by Independent Review Committee (IRC)
timeFrame: Up to disease progression or end of study (up to 2 years and 9 months)
measure: Progression-Free Survival (PFS) as Centrally Measured by Independent Review Committee (IRC)
timeFrame: From the start of the study up to disease progression or death (up to 2 years and 9 months)
measure: Overall Survival (OS)
timeFrame: Until death or loss to follow-up or end of study (up to 2 years and 9 months)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Assessed by National Cancer Institute Common Terminology Criteria (NCI CTCAE) v5.0 and Serious Adverse Events (SAEs)
timeFrame: From first dose of study drug up to 30 days post last dose (Up to 2 years and 9 months)
measure: Trough Concentration at Steady State (Ctrough,ss) of Debio 1347 in Plasma
timeFrame: Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days)
measure: Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of Debio 1347 in Plasma
timeFrame: Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days)
measure: Correlation of Debio 1347 Plasma Concentration (C) and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
timeFrame: Pre-dose on Days 14 and 28, and 1, 3, 7 hours post-dose on Day 28 of Cycle 1; pre-dose on Days 14 and 28, and 3 hours post-dose on Day 28 of Cycle 2 (each cycle length = 28 days)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Ironwood Cancer & Research Centers - Scottsdale
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute, Inc
state: Florida
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Cancer Center
state: Louisiana
city: Baltimore
country: United States
facility: The John Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Middletown
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: UC Health, LLC.
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center - James Cancer Hospital
state: Ohio
city: Tulsa
country: United States
facility: CTCA Cancer Treatment Centers
state: Oklahoma
city: Pittsburgh
country: United States
facility: West Penn - Allegheny Oncology Network
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospitals & Clinics
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson/Seattle Care Alliance
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Bowral
country: Australia
facility: Southern Highlands Private Hospital
city: Frankston
country: Australia
facility: Peninsula and Southeast Oncology (PASO)
city: Nedlands
country: Australia
facility: Linear Clinical Research, B Block Sir Charles Gairdner Hospital
city: Tugun
country: Australia
facility: John Flynn Private Hospital
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wiener Neustadt
city: Ijuí
country: Brazil
facility: Hospital de Caridade de Ijuí, Avenida David J Martins
city: Rio Grande
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
city: Santo André
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
city: São Paulo
country: Brazil
facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, Avenida Doutor Arnaldo
city: Dobrich
country: Bulgaria
facility: MHAT - Dobrich
city: Plovdiv
country: Bulgaria
facility: Complex Oncological Center - Plovdiv, EOOD
city: Sofia
country: Bulgaria
facility: MHAT "Serdika", EOOD
city: Varaždin
country: Croatia
facility: General Hospital Varazdin
city: Zagreb
country: Croatia
facility: University Hospital Centre, Sestre Milosrdnice
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Prague
country: Czechia
facility: Thomayerova nemocnice
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Aalborg
country: Denmark
facility: Ålborg Universitets Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Helsinki
country: Finland
facility: Docrates Syöpäsairaala
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Angers
country: France
facility: ICO - Site Paul Papin
city: Bordeaux
country: France
facility: CHU Bordeaux - Hôpital Saint André, Groupe Hospitalier Sud - Hôpital Haut-Lévêque
city: Lille
country: France
facility: Centre Oscar Lambret
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque
city: Saint-Herblain
country: France
facility: ICO - Site René Gauducheau
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Athens
country: Greece
facility: General Hospital of Athens Laiko
city: Athens
country: Greece
facility: General Hospital of Athens of Chest Diseases "SOTIRIA"
city: Athens
country: Greece
facility: General Hospital of Athens "Alexandra"
city: Ioánnina
country: Greece
facility: University General Hospital of Ioannina
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital, Department of Oncology Medical office
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital, CRC Room, 3F
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center, CRC Room, 18F, Artificial intelligence hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital (SNUH)
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital, CRC room, Clinical Trial Center
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Radiumhospitalet, Montebello
city: Cebu City
country: Philippines
facility: Cebu Doctors' University Hospital (CDUH), Research Office
city: Ermita
country: Philippines
facility: Philippine General Hospital, Clinical Trial Unit Room 5, Medical Research Laboratory
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center, Human Cancer Biobank Research Center
city: Poznań
country: Poland
facility: Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu
city: Warszawa
country: Poland
facility: MTZ Clinical Research
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
city: Bucuresti
country: Romania
facility: S.C Delta Health Care S.R.L
city: Cluj-Napoca
country: Romania
facility: S.C Medisprof S.R.L.
city: Craiova
country: Romania
facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L.
city: Timişoara
country: Romania
facility: S.C Oncocenter Oncologie Clinica S.R.L.
city: Arkhangel'sk
country: Russian Federation
facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
city: Barnaul
country: Russian Federation
facility: TSBHI "Altai Territorial oncological dispensary"
city: Chelyabinsk
country: Russian Federation
facility: LLC Evimed
city: Moscow
country: Russian Federation
facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
city: Omsk
country: Russian Federation
facility: BHI of Omsk region "Clinical Oncology Dispensary"
city: Tomsk
country: Russian Federation
facility: Tomsk Research Instutite of Oncology
city: Singapore
country: Singapore
facility: Singapore National Cancer Center (SNCC)
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital, Communicable Disease Centre
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: New Taipei City
country: Taiwan
facility: Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital, The Radiation Oncology Department
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital (TMUH)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital, Medical Science & Technology Building
city: Taoyuan
country: Taiwan
facility: Linkou Chang-Gung Memorial Hospital
city: Dnipro
country: Ukraine
facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
city: Kharkiv
country: Ukraine
facility: SI V.T. Zaycev Institute of general & urgent surgery of National academy medical sciences of Ukraine, Department of purulent surgery
city: Kharkiv
country: Ukraine
facility: Communal Non-profit Enterprise Regional Center of Oncology
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: The Christie
Study officials:
References: