A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:September 14, 2018
End Date:July 1, 2024
Contact:Medical Lead
Email:FPA144004@fiveprime.com
Phone:(844) 333-5349

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FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 3 Preceded by Dose-Finding in Phase 1

This is a global, randomized, double-blind, controlled study to evaluate the efficacy of
bemarituzumab (FPA144) + mFOLFOX6 versus placebo + mFOLFOX6 in patients with FGFR2 selected
Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA blood
assay demonstrating FGFR2 gene amplification)

The main purpose of this study is to evaluate the efficacy of bemarituzumab (FPA144), which
is a targeted antibody, in combination with modified FOLFOX6 compared to placebo in
combination with modified FOLFOX6 in participants with Gastric Cancer as measured by overall
survival.

Key Inclusion Criteria:

- Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not
amenable to curative therapy)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- Adequate hematological, liver and kidney function. Measurable or non-measurable, but
evaluable disease using RECIST v1.1

- FGFR2b overexpression as determined by a centrally performed IHC tissue test and/or
FGFR2 gene amplification as determined by a centrally performed ctDNA blood based
assay

- Candidate for mFOLFOX6 chemotherapy

Key Exclusion Criteria:

- Untreated or symptomatic central nervous system (CNS) metastases

- Clinically significant cardiac disease,

- Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events
(CTCAE) Grade 2

- Active infection requiring systemic treatment

- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness, or known active or chronic hepatitis B or C infection

- Prior treatment with any selective inhibitor of the fibroblast growth factor
(FGF)-FGFR pathway

- Known abnormalities of the cornea that may pose an increased risk of developing a
corneal ulcer

- Known positivity for HER2

- Women who are pregnant or breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
23
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Whittier, CA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Arlington, Texas 76012
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Bethlehem, PA
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119-143 Missenden Road
Camperdown, 2050
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Camperdown,
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Detroit, Michigan 48201
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Knoxville, Tennessee 37920
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Morristown, New Jersey 07960
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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New Orleans, Louisiana 70121
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Tucson, Arizona 85724
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Tucson, Arizona 85745
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Westwood, Kansas 66205
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