Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)
Status: | Recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/31/2019 |
Start Date: | March 1, 2019 |
End Date: | August 31, 2022 |
Contact: | Debiopharm International S.A |
Email: | clinicaltrials@debiopharm.com |
Phone: | +41 21 321 01 11 |
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
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.
objective response rate (ORR) in participants with solid tumors harboring fibroblast growth
factor receptor (FGFR)1-3 gene fusion/rearrangement.
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)
We found this trial at
15
sites
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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