Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)

Stopped early · Phase 2

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT03834220

Run by

Debiopharm International SA

People needed

63

Starts

2019-03-22

Expected to finish

2022-01-04

Last updated by the study team

2024-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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
• Ironwood Cancer & Research Centers - Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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