CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0275 (clinicaltrials.gov NCT No: NCT00814073)
Title:A 24-week with possible extension, prospective, multicentre, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, Phase III study to compare efficacy and safety of masitinib at 6 mg/kg/day to placebo in treatment of patients with Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicap
Principal Investigator:Srdan Verstovsek
Treatment Agent:Masitinib
Study Status:Open
Study Description:The goal of this clinical research study is to compare the benefits of
treatment with masitinib to no treatment in patients with mastocytosis with
handicap.

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Disease Group:Hematologic Disorder
Phase of Study:Phase III
Treatment Agents:Masitinib
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:N/A
Supported By:AB Science
Return Visit:Eligible patients will be treated with masitinib or matching placebo for 24
weeks with possible extension. Patients will be seen every 4 Weeks during the
protocol period, and then every 12 weeks during the possible extension period.
Home Care:Self Medicated


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Physician Name:Srdan Verstovsek
Dept:Leukemia
For Clinical Trial Enrollment:713-745-3429
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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