Masitinib in Combination With FOLFIRI in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer

Sponsor
AB Science
Study ID
NCT03556956
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

Study Details

A prospective, multicentre, open-label, randomized, phase 2-3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care, in third or fourth line treatment of patients with metastatic colorectal cancer

Key Dates

Start date
Jul 31, 2015
Status verified
Apr 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

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

Arms

  • Experimental: Masitinib plus FOLFIRI
    Masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid). Masitinib will be prescribed until disease progression (or treatment switch to next line of treatment), death, limiting toxicity or patient consent withdrawal.
  • No Intervention: Best Supportive Care
    Best Supportive Care (BSC) includes any concomitant medications or treatments: antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy necessary to provide BSC, except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.

Primary Outcome Measure

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

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