FIGHT: FPA144-004 Advanced Gastric and Gastroesophageal Cancer
Research type
Research Study
Full title
FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 3 Preceded by Dose-Finding in Phase 1
IRAS ID
248710
Contact name
Russell Petty
Contact email
Sponsor organisation
Five Prime Therapeutics, Inc.
Eudract number
2017-003507-22
Duration of Study in the UK
5 years, 4 months, 2 days
Research summary
This is a multi-center, randomised, double-blinded, placebo-controlled Phase 3 study evaluating the benefit of the addition of FPA144/bemarituzumab to the chemotherapy combination of mFOLFOX6 (a combination of 5-fluorouracil, oxaliplatin, and leucovorin) for patients with FGFR2b-positive advanced gastric or gastroesophageal cancer. Prior treatment for advanced disease with chemotherapy (does not include adjuvant or neoadjuvant therapy – ie treatment at or following the time of surgery with the goal of disease cure) or FGF-FGFR pathway inhibitors is not allowed.
Eligible patients will be randomised to receive mFOLFOX6 + placebo or mFOLFOX6+FPA144 and will not know which combination they are receiving until the study results are analysed. All patients will receive study treatment until disease progression, unacceptable toxicity or the patient withdraws from the study; patients will be followed after completion of treatment for survival.
The primary endpoint is overall survival and secondary endpoints include but are not limited to progression-free survival, overall response rate, and incidence of adverse events. It is estimated that a total of 548 patients will participate in Phase 3 of this research study at approximately 250 study centers around the world.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0001
Date of REC Opinion
26 Feb 2019
REC opinion
Further Information Favourable Opinion