Phase 1 Exploratory Study of FPA144 Plus mFOLFOX6 for Gastric Malignancies
Researchers are evaluating the safety/tolerability, pharmacokinetics, and pharmacodynamics of FPA144 plus 5-fluorouracil, leucovorin, and oxaliplatin among patients with gastrointestinal cancers.
Title: A Study of FPA144 Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer (FIGHT)1
Principal Investigator: Medical Lead, Five Prime Therapeutics, Inc
Description: For this open-label, multi-center phase 1 study (ClinicalTrials.gov Identifier: NCT03343301), researchers are evaluating the safety/tolerability, pharmacokinetics, and pharmacodynamics of FPA144 plus 5-fluorouracil (5-FU), leucovorin, and oxaliplatin (mFOLFOX6) among patients with gastrointestinal cancers.
Cohorts of 3 to 6 patients will receive intravenous (IV) FPA144 over 30 minutes and then mFOLFOX6 (IV oxaliplatin 85 mg/m2 plus IV leucovorin 400 mg/m2 over 2 hours, then 5-FU 400 mg/m2 over 5 minutes and 5-FU 2400 mg/m2 as continuous IV infusion over 46 hours) 30 minutes upon completion of the FPA144 infusion every 2 weeks.
The primary outcomes of the study are the incidence of grade 3 to 4 adverse events, corneal thinning and/or corneal ulcers, and the recommended dose of FPA144 in combination with mFOLFOX6.
Estimated study enrollment is 21 patients.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03343301.
Status: Open and recruiting patients as of January 16, 2018.
This study is sponsored by Five Prime Therapeutics, Inc.
- ClinicalTrials.gov. A study of FPA144 combined with modified FOLFOX6 in gastric/gastroesophageal cancer (FIGHT). NCT03343301. https://clinicaltrials.gov/ct2/show/NCT03343301. Accessed January 16, 2017.