Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib

Sponsor
AB Science
Study ID
NCT01506336
Phase
PHASE2
Status
Completed

Conditions

  • Gastro Intestinal Stromal Tumor

Eligibility Criteria

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

Interventions

  • masitinib — DRUG
    masitinib 12 mg/kg/day
  • sunitinib — DRUG
    sunitinib 50 mg/day

Study Details

The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.

Key Dates

Start date
Oct 31, 2008
Status verified
Dec 2018
Primary completion
Sep 30, 2011
Completion
Apr 30, 2012

Study Design

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

Arms

  • Experimental: masitinib
    masitinib 12 mg/kg/day
  • Active Comparator: sunitinib
    sunitinib 50 mg/day

Primary Outcome Measure

overall progression free survival [ Time Frame: up to 36 weeks ]