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A Prospective, Multicenter, Double-randomized, Double-blind, 2-parallel Groups, Phase 3 Study to Compare as First Line Therapy Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Gemcitabine in Combination With Placebo, in the Treatment of Patients With Non Resectable Locally Advanced or Metastatic Pancreatic Cancer

Trial Profile

A Prospective, Multicenter, Double-randomized, Double-blind, 2-parallel Groups, Phase 3 Study to Compare as First Line Therapy Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Gemcitabine in Combination With Placebo, in the Treatment of Patients With Non Resectable Locally Advanced or Metastatic Pancreatic Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2019

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At a glance

  • Drugs Masitinib (Primary) ; Fluorouracil; Folinic acid; Gemcitabine; Irinotecan
  • Indications Adenocarcinoma; Pancreatic cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors AB Science
  • Most Recent Events

    • 12 Jun 2019 The Independent Data Monitoring Committee (IDMC) recommended continuation of the trial, based on pre-planned interim analysis making interim analysis decisive for study continuation. The interim analysis was performed once 50% of the events had been reached in the pre specified sub-group of patients with unresectable locally advanced tumours.The IDMC did not recommend to discontinue any patient.
    • 05 Jun 2019 According to an AB science media release, the final read-out for the study is expected in 2020.
    • 30 May 2019 According to an AB science media release, data from this trial with the upcoming interim analysis will be reviewed in the company webcast on 5 June 2019
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