Masitinib in Patients With Mastocytosis With Handicap and Bearing the D816V Mutation

Sponsor
AB Science
Study ID
NCT01266369
Phase
PHASE2
Status
Completed

Conditions

  • Mastocytosis

Eligibility Criteria

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

Interventions

Study Details

The objective is to compare efficacy and safety of AB1010 at 3 or 6 mg/kg/day in treatment of patients with mastocytosis with handicap and bearing activating point mutations in the phosphotransferase domain of c-Kit such as the main mutation Asp-816-Val (D816V).

Key Dates

Start date
Feb 28, 2007
Status verified
Dec 2018
Primary completion
Nov 30, 2007
Completion
May 31, 2010

Study Design

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

Arms

  • Experimental: masitinib 3 mg/kg/day
    masitinib 3 mg/kg/day
  • Experimental: masitinib 6 mg/kg/day
    masitinib 6 mg/kg/day

Primary Outcome Measure

efficacy on handicaps [ Time Frame: week 12 ]

Related Studies