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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.

Trial Profile

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.

Status: Completed
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
  • Most Recent Events

    • 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.
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