Description:
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)
Title
- Brief Title: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)
- Official Title: FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1
Clinical Trial IDs
- ORG STUDY ID:
FPA144-004 Phase 2
- NCT ID:
NCT03694522
Conditions
Interventions
Drug | Synonyms | Arms |
---|
bemarituzumab (FPA144) | | bemarituzumab (FPA144)+mFOLFOX6 |
Placebo | | Placebo+mFOLFOX6 |
mFOLFOX6 | | Placebo+mFOLFOX6 |
Purpose
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)
Detailed Description
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.
Trial Arms
Name | Type | Description | Interventions |
---|
bemarituzumab (FPA144)+mFOLFOX6 | Active Comparator | 15mg/kg of bemarituzumab (FPA144) given intravenously and mFOLFOX6 administered after the end of the bemarituzumab (FPA144) infusion
*Cycle 1 will consist of a one-time dose of 7.5 mg/kg of bemarituzumab (FPA144) given intravenously on Day 8
Treatment is repeated every 2 weeks. | - bemarituzumab (FPA144)
- mFOLFOX6
|
Placebo+mFOLFOX6 | Placebo Comparator | Placebo given intravenously and mFOLFOX6 administered after the end of the placebo infusion
* Cycle 1 will consist of a one-time dose of placebo given intravenously on Day 8
Treatment is repeated every 2 weeks. | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-Free Survival (PFS) |
Time Frame: | up to approximately 30 months |
Safety Issue: | |
Description: | Time from enrollment until the EARLIER OF a. progression or b. death from any cause. |
Secondary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | Up to approximately 30 months |
Safety Issue: | |
Description: | Time from enrollment until death from any cause |
Measure: | Overall response rate (ORR) |
Time Frame: | Up to approximately 30 months |
Safety Issue: | |
Description: | Proportion of patients with partial or complete response based on assessment of tumor lesions per RECIST v1.1 |
Measure: | Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 |
Time Frame: | Through completion of study treatment, an average of 1 year |
Safety Issue: | |
Description: | Treatment-Emergent Adverse Events (TEAEs) classified by MedDRA preferred term and assessed by CTCAE. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Five Prime Therapeutics, Inc. |
Last Updated
May 3, 2021