Catalyst
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Five Prime Therapeutics Receives FDA Orphan Drug Designation for FPA144 for the Treatment of Gastric Cancer
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Additional Information
The Phase 1 clinical trial of FPA144 has two parts. The first part of the trial will enroll unselected patients with solid tumors to explore the safety of the drug and identify a dose for expansion to test in patients with gastric cancer. During the second part of the trial, Five Prime will enroll gastric cancer patients with FGFR2b protein overexpression or FGFR2 gene amplification in their tumors as identified through proprietary molecular diagnostic assays. Important endpoints of the trial include safety and overall response rate.
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Catalyst Date
Occurred on:
Jul 05, 2016
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Related Keywords
Orphan Drug Designation, Fgfr2b Protein Overexpression, Gastric Cancer, Fpa144