Masitinib in Combination With FOLFIRI for Second-line Treatment of Patients With Metastatic Colorectal Cancer

Sponsor
AB Science
Study ID
NCT02605044
Phase
PHASE3
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 31, 2014
Status verified
Feb 2019
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
123 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Masitinib + FOLFIRI
    masitinib + FOLFIRI
  • Placebo Comparator: Placebo + FOLFIRI
    Placebo + FOLFIRI

Primary Outcome Measure

Overall survival [ Time Frame: From day of randomization to death, assessed for a maximum of 60 months ]

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