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
Trial ID: NCT03834220
Status: TERMINATED
Study type: INTERVENTIONAL
Phase: PHASE2
Start date: 2019-03-22
Completion date: 2022-01-04
Sponsor: Debiopharm International SA
Collaborators: Caris Life Sciences; Optimal Research (Just In Time sites)
Conditions: Solid Tumor
Interventions: Debio 1347
Locations: Ironwood Cancer & Research Centers - Scottsdale; University of Arizona Cancer Center; Moores UCSD Cancer Center; University of California San Francisco; Sarcoma Oncology Center; H. Lee Moffitt Cancer Center and Research Institute, Inc; James Graham Brown Cancer Center; Tulane University Cancer Center; The John Hopkins Hospital; Massachusetts General Hospital; Dana-Farber Cancer Institute; University of Michigan; Memorial Sloan Kettering Cancer Center; Rutgers Cancer Institute of New Jersey; Memorial Sloan Kettering Cancer Center; Memorial Sloan-Kettering Hospital; University of North Carolina at Chapel Hill; UC Health, LLC.; The Ohio State University Wexner Medical Center - James Cancer Hospital; CTCA Cancer Treatment Centers; West Penn - Allegheny Oncology Network; MD Anderson Cancer Center; University of Utah Hospitals & Clinics; Fred Hutchinson/Seattle Care Alliance; University of Wisconsin; Southern Highlands Private Hospital; Peninsula and Southeast Oncology (PASO); Linear Clinical Research, B Block Sir Charles Gairdner Hospital; John Flynn Private Hospital; LKH - Universitätsklinikum der PMU Salzburg; Landesklinikum Wiener Neustadt; Hospital de Caridade de Ijuí, Avenida David J Martins; Hospital de Clínicas de Porto Alegre; CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia; ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, Avenida Doutor Arnaldo; MHAT - Dobrich; Complex Oncological Center - Plovdiv, EOOD; MHAT "Serdika", EOOD; General Hospital Varazdin; University Hospital Centre, Sestre Milosrdnice; Fakultni nemocnice u sv. Anny v Brne; Fakultni nemocnice Hradec Kralove; Fakultni nemocnice Olomouc; Fakultni nemocnice Kralovske Vinohrady; Thomayerova nemocnice; Ålborg Universitets Hospital; Herlev Hospital; Odense Universitetshospital; Docrates Syöpäsairaala; Helsinki University Hospital; ICO - Site Paul Papin; CHU Bordeaux - Hôpital Saint André, Groupe Hospitalier Sud - Hôpital Haut-Lévêque; Centre Oscar Lambret; Groupe Hospitalier Sud - Hôpital Haut Lévêque; ICO - Site René Gauducheau; Institut Gustave Roussy; General Hospital of Athens Laiko; General Hospital of Athens of Chest Diseases "SOTIRIA"; General Hospital of Athens "Alexandra"; University General Hospital of Ioannina; VU Medisch Centrum; Haga Ziekenhuis; Akershus University Hospital; Radiumhospitalet, Montebello; Cebu Doctors' University Hospital (CDUH), Research Office; Philippine General Hospital, Clinical Trial Unit Room 5, Medical Research Laboratory; St. Luke's Medical Center, Human Cancer Biobank Research Center; Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu; MTZ Clinical Research; Centrum Onkologii-Instytut im.M.Sklodowskiej Curie; S.C Delta Health Care S.R.L; S.C Medisprof S.R.L.; S.C Centrul de Oncologie Sf. Nectarie S.R.L.; S.C Oncocenter Oncologie Clinica S.R.L.; SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"; TSBHI "Altai Territorial oncological dispensary"; LLC Evimed; FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; BHI of Omsk region "Clinical Oncology Dispensary"; Tomsk Research Instutite of Oncology; Singapore National Cancer Center (SNCC); Tan Tock Seng Hospital, Communicable Disease Centre; Seoul National University Bundang Hospital, Department of Oncology Medical office; The Catholic University of Korea, St. Vincent's Hospital, CRC Room, 3F; Gachon University Gil Medical Center, CRC Room, 18F, Artificial intelligence hospital; Korea University Anam Hospital; Seoul National University Hospital (SNUH); Ajou University Hospital, CRC room, Clinical Trial Center; Hospital Universitari Vall d'Hebron; Centro Integral Oncologico Clara Campal; Hospital Clinico Universitario de Valencia; Shuang Ho Hospital; Taichung Veterans General Hospital, The Radiation Oncology Department; National Cheng Kung University Hospital; National Taiwan University Hospital; Taipei Medical University Hospital (TMUH); Taipei Veterans General Hospital, Medical Science & Technology Building; Linkou Chang-Gung Memorial Hospital; CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU; SI V.T. Zaycev Institute of general & urgent surgery of National academy medical sciences of Ukraine, Department of purulent surgery; Communal Non-profit Enterprise Regional Center of Oncology; Ninewells Hospital; Guy's Hospital; Hammersmith Hospital; The Christie
Countries: United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; Australia; Australia; Australia; Australia; Austria; Austria; Brazil; Brazil; Brazil; Brazil; Bulgaria; Bulgaria; Bulgaria; Croatia; Croatia; Czechia; Czechia; Czechia; Czechia; Czechia; Denmark; Denmark; Denmark; Finland; Finland; France; France; France; France; France; France; Greece; Greece; Greece; Greece; Netherlands; Netherlands; Norway; Norway; Philippines; Philippines; Philippines; Poland; Poland; Poland; Romania; Romania; Romania; Romania; Russia; Russia; Russia; Russia; Russia; Russia; Singapore; Singapore; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; Spain; Spain; Spain; Taiwan; Taiwan; Taiwan; Taiwan; Taiwan; Taiwan; Taiwan; Ukraine; Ukraine; Ukraine; United Kingdom; United Kingdom; United Kingdom; United Kingdom
Enrollment: 63
Age range: 18 Years - None
Sex: ALL

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)

Outcomes:
Objective Response Rate (ORR) as Centrally Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria