Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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)

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

Details

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.

Keywords

Gastric Cancer Stomach Neoplasms bemarituzumab (FPA144) mFOLFOX6 bemarituzumab (FPA144)+mFOLFOX6

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Medical Centre - Santa Monica Hematology and Oncology
    Santa Monica California 90404 United States
  • Marin Cancer Care, Inc-California Cancer Care A Medical Group, Inc
    Greenbrae California 94904 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Five Prime Therapeutics, Inc.
ID
NCT03694522
Phase
Phase 2
Study Type
Interventional
Last Updated