A prospective, multicentre, open-label, randomised, phase 2 study to evaluate the efficacy and safety of masitinib in combination with 5-fluorouracil (5-FU), or masitinib in combination with irinotecan, or masitinib in combination with irinotecan, 5-fluorouracil (5-FU) and folinic acid (FOLFIRI protocol), as second line therapy in patients with gastric or gastro-oesophageal junction metastatic adenocarcinoma
Phase of Trial: Phase I/II
Latest Information Update: 16 Sep 2015
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.