CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Bemarituzumab +1 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/NCT03343301
NCT03343301Phase 1Completed
CompareCT.gov

FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 2 Preceded by Dose Finding in Phase 1

Five Prime Therapeutics, Inc.·interventional·Posted Nov 17, 2017·Updated Feb 28, 2024

In Brief

A Phase 1 clinical trial evaluating Bemarituzumab and Modified FOLFOX6 for Gastrointestinal Cancer and 2 related conditions. Completed, enrolled 12 participants across 7 sites.

Detailed Summary

The primary objective of the phase 1 portion of this study is to determine the recommended dose of bemarituzumab in combination with 5-fluorouracil, leucovorin and oxaliplatin (modified FOLFOX6) to use in the phase 2 portion of the trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Cancer, Gastrointestinal Cancer Metastatic, Gastric Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartNov 30, 2017
Primary CompletionJan 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.6 years ago

Interventions

Bemarituzumabbiological

Administered by intravenous infusion over approximately 30 minutes

Modified FOLFOX6drug

Modified FOLFOX6 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.