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

Use our guide to learn which trials are right for you!

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
sites
Arlington, Texas 76012
?
mi
from
Arlington, TX
Click here to add this to my saved trials
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
119-143 Missenden Road
Camperdown, 2050
?
mi
from
Camperdown,
Click here to add this to my saved trials
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...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Greenbrae, CA
Click here to add this to my saved trials
Knoxville, Tennessee 37920
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Morristown, New Jersey 07960
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
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...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
Plainville, CT
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
S. Salt Lake, UT
Click here to add this to my saved trials
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Tucson, Arizona 85724
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tucson, Arizona 85745
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Warrenville, IL
Click here to add this to my saved trials
Westwood, Kansas 66205
?
mi
from
Westwood, KS
Click here to add this to my saved trials
?
mi
from
White Plains, NY
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials