A prospective, multicentre, open-label, randomised, uncontrolled, phase 1/2 study to evaluate the efficacy and safety of masitinib in combination with 5-fluorouracil (5-FU) or capecitabine, or masitinib in combination with irinotecan, or masitinib in combination with irinotecan, 5-fluorouracil (5-FU) and folinic acid (FOLFIRI protocol), as second line chemotherapy in patients with gastric or gastro-oesophageal junction metastatic adenocarcinoma.
Phase of Trial: Phase I/II
Latest Information Update: 19 Jun 2019
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At a glance
- Drugs Masitinib (Primary) ; Capecitabine; Fluorouracil; Folinic acid; Irinotecan
- Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
- Focus Proof of concept; Therapeutic Use
- 16 Sep 2015 Results published in an AB Sciences media release.
- 16 Sep 2015 According to an AB Sciences media release, the U.S. Food and Drug Administration (FDA) has granted the Orphan Drug designation for masitinib in the treatment of esophagogastric adenocarcinoma.
- 25 Jun 2015 Status changed from recruiting to completed, according to an AB Science media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History