At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 155 enrolled

Drug / intervention

Bemarituzumab +2 morebiological

Likely dose

Modified FOLFOX6 85 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03694522

NCT03694522Phase 2Completed

Compare CT.gov

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

Five Prime Therapeutics, Inc.·interventional·Posted Oct 3, 2018·Updated Feb 28, 2024

In Brief

A Phase 2 clinical trial evaluating Bemarituzumab, Placebo, and 1 other intervention for Gastric Cancer. Completed, enrolled 155 participants across 189 sites in 18 countries.

Detailed Summary

The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGastric Cancer

CountriesAustralia, Belgium, China, France, Germany, Hungary, Italy, Japan, Poland, Portugal, Romania, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States

CollaboratorsZai Lab (Shanghai) Co., Ltd.

Timeline

Phase 2CompletedFinished

20192020202120222023202420252026

Enrollment StartSep 2018

First PostedOct 2018

Primary CompletionSep 2020

Study CompletionMay 2022

TodayJul 2026

First PostedOct 3, 2018

Enrollment StartSep 14, 2018

Primary CompletionSep 23, 2020

Study CompletionMay 13, 2022

TodayJul 2, 2026

Enrollment to primary: 2.0 yearsPosted 7.7 years ago

Interventions

Bemarituzumabbiological

Administered by intravenous infusion over approximately 30 minutes

Placebodrug

Administered by intravenous infusion over approximately 30 minutes

Modified FOLFOX6drug

mFOLFOX6 regimen consists of the following: * Oxaliplatin 85 mg/m² IV infusion over 120 minutes * Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable * 5-fluorouracil (5-FU) 400 mg/m² bolus over approximately 5 minutes then 5-FU 2400 mg/m² as a continuous IV infusion over approximately 48 hours