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 |
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)
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.
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
University of Chicago One of the world's premier academic and research institutions, the University of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
Click here to add this to my saved trials
Click here to add this to my saved trials
Plainville, Connecticut 06062
Click here to add this to my saved trials
Rochester, New York 14642
Click here to add this to my saved trials
S. Salt Lake, Utah 84106
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials