Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis

Part of paid clinical trials in Sacramento, California.

Sponsor
AB Science
Study ID
NCT00814073
Phase
PHASE3
Status
Completed

Conditions

  • Indolent Systemic Mastocytosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Masitinib — DRUG
    Masitinib 6 mg/kg/day
  • Placebo — DRUG
    Matching placebo
  • Best Supportive Care — OTHER
    Optimal concomitant symptomatic treatments. Includes: H1- and H2-antihistamines, proton pump inhibitors (PPI), sodium cromoglicate, antidepressants, leukotriene antagonists, interferon-alpha, 2-CdA, and corticosteroids.

Study Details

The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.

Key Dates

Start date
Dec 31, 2008
Status verified
Nov 2019
Primary completion
Nov 30, 2015
Completion
Nov 30, 2015

Study Design

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

Arms

  • Experimental: Masitinib & BSC
    Masitinib (6 mg/kg/day) administered as an add-on to optimal concomitant symptomatic treatment (i.e. best supportive care, BSC)
  • Placebo Comparator: Placebo & BSC
    Matching placebo administered as an add-on to optimal concomitant symptomatic treatment (i.e. best supportive care, BSC)

Primary Outcome Measure

Cumulative response (4R75%) [ Time Frame: 24 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
UC Davis Health System , Department of DermatologySacramentoCalifornia95816-
MD Anderson Cancer CentreHoustonTexas77030-

Find similar trials in Sacramento, CA

By research site
UC Davis Health System , Department of Dermatology· Sacramento, CAMD Anderson Cancer Centre· Houston, TX

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