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
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University of Chicago One of the world's premier academic and research institutions, the University of...
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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...
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Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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Plainville, Connecticut 06062
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Rochester, New York 14642
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S. Salt Lake, Utah 84106
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