Study to Compare the Efficacy and Safety of Masitinib in Combination With FOLFIRI to Placebo in Combination With FOLFIRI in Second Line Treatment of Patients With Metastatic Colorectal Cancer

Official Title

A Prospective, Multicentre, Randomized, Double Blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With FOLFIRI (Irinotecan, 5-fluorouracil and Folinic Acid) to Placebo in Combination With FOLFIRI in Second Line Treatment of Patients With Metastatic Colorectal Cancer

Summary:

The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI ( irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients.

Trial Description

Primary Outcome Measures:

  • Overall survival
Secondary Outcome Measures:
  • Survival rate
  • Tumour assessment (PFS)
  • Tumour assessment (TTP)
  • Tumour assessment (Best Response)
  • Quality of life (ECOG)
  • Quality of life (analgesic intake)
  • Pharmacogenomic assessment (Gene typing)
  • Safety profile (all adverse effects)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society