Status:
TERMINATED
Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)
Lead Sponsor:
Debiopharm International SA
Collaborating Sponsors:
Caris Life Sciences
Optimal Research (Just In Time sites)
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (FGF...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2022
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03834220
Start Date
March 22 2019
End Date
January 4 2022
Last Update
February 7 2024
Active Locations (105)
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1
Ironwood Cancer & Research Centers - Scottsdale
Scottsdale, Arizona, United States, 85260
2
University of Arizona Cancer Center
Tucson, Arizona, United States, 85721
3
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
4
University of California San Francisco
San Francisco, California, United States, 94115