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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 14, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

September 14, 2018

Estimated Primary Completion Date

July 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall Survival (OS)[ Time Frame: up to approximately 46 months ]

Time from enrollment until death from any cause

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Progression-free survival (PFS)[ Time Frame: Up to approximately 46 months ]
time from enrollment until the EARLIER OF a. progression or b. death from any cause.
Overall response rate (ORR)[ Time Frame: Up to approximately 46 months ]
Proportion of patients with partial or complete response based on assessment of tumor lesions per RECIST v1.1
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03[ Time Frame: Through completion of study treatment, an average of 1 year ]
Treatment-Emergent Adverse Events (TEAEs) classified by MedDRA preferred term and assessed by CTCAE.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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)

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:Double blinded (participant, treating physician)
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: bemarituzumab (FPA144)
bemarituzumab (FPA144)
Drug: Placebo
Placebo
Drug: mFOLFOX6
mFOLFOX6

Study Arms

Active Comparator: bemarituzumab (FPA144)+mFOLFOX6
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.
Placebo Comparator: Placebo+mFOLFOX6
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.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

548

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 1, 2024

Estimated Primary Completion Date

July 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Five Prime Therapeutics, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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