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Brief Title: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer
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
Study ID: NCT03343301
Brief 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.
Detailed 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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The University of Arizona Cancer Center, Tucson, Arizona, United States
Marin Cancer Care, Greenbrae, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Wilmont Cancer Institute, Rochester, New York, United States
Tennessee Cancer Specialists, Knoxville, Tennessee, United States
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR