Systemic Mastocytosis Clinical Trial
Official title:
Multicenter, Open-Label, Single Arm Phase II Clinical Trial of Dasatinib in the Treatment of Systemic Mastocytosis
This is a multicenter, open-label, single arm phase II non-randomized study of dasatinib in
which subjects with systemic mastocytosis (SM) will be treated with a continuous regimen of
dasatinib.
Upon completion of a treatment induction period, subjects will be treated with dasatinib at
a dose of 100 mg per os (OS) once daily (QD).
Dasatinib may have clinical efficacy and is safe in subjects with SM. This Multicenter,
open-label, single arm Phase II study will investigate the clinical response rate in terms
of both B/C findings and mediator-related symptoms.
30 adult patients will be treated with a continuous regimen of dasatinib at a starting dose
of 20 mg administered orally (PO) once daily (QD), that can be escalated up to 100 mg QD at
the end of Week 3. Upon completion of a treatment induction period, subjects will be treated
with dasatinib at a daily dose of 100 mg PO QD. Patients will remain on dasatinib treatment
for 12 months unless disease progression, unacceptable toxicity or other reasons determine
treatment discontinuation. Subjects may continue receiving protocol therapy as long as they
are deriving a clinical benefit.
Additionally, all subjects will be followed until disease progression, death, or 12 months
beyond discontinuation from study treatment.
The total duration of the study is estimated to 36 months.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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