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

Gastric Cancer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

Phase 1 is an open-label dose-escalation of bemarituzumab in combination with modified FOLFOX6 (mFOLFOX6). Eligible patients will have unresectable locally advanced or metastatic GI cancer of any type and be candidates to receive at least 2 doses of mFOLFOX6 chemotherapy. Phase 1 consists of 2 dosing cohorts of bemarituzumab in combination with mFOLFOX6 to determine the recommended dose of bemarituzumab in combination with mFOLFOX6 for the phase 2 portion of the study (see study record NCT03694522). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03343301
Study type Interventional
Source Five Prime Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date November 30, 2017
Completion date January 31, 2019
View Details
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