Clinical Trials /

A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)

NCT03694522

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)

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: FPA144-004 Phase 3
  • NCT ID: NCT03694522

Conditions

  • Gastric Cancer

Interventions

DrugSynonymsArms
bemarituzumab (FPA144)bemarituzumab (FPA144)+mFOLFOX6
PlaceboPlacebo+mFOLFOX6
mFOLFOX6bemarituzumab (FPA144)+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

NameTypeDescriptionInterventions
bemarituzumab (FPA144)+mFOLFOX6Active Comparator15mg/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+mFOLFOX6Placebo ComparatorPlacebo 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.
  • Placebo
  • mFOLFOX6

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:Overall Survival (OS)
Time Frame:up to approximately 46 months
Safety Issue:
Description:Time from enrollment until death from any cause

Secondary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:Up to approximately 46 months
Safety Issue:
Description:time from enrollment until the EARLIER OF a. progression or b. death from any cause.
Measure:Overall response rate (ORR)
Time Frame:Up to approximately 46 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 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Five Prime Therapeutics, Inc.

Last Updated