Evaluation of Response of Dasatinib to Treat Mastocytosis
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|ClinicalTrials.gov Identifier: NCT00979160|
Recruitment Status : Unknown
Verified September 2009 by Federico II University.
Recruitment status was: Not yet recruiting
First Posted : September 17, 2009
Last Update Posted : September 18, 2009
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).
|Condition or disease||Intervention/treatment||Phase|
|Systemic Mastocytosis||Drug: Dasatinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open-Label, Single Arm Phase II Clinical Trial of Dasatinib in the Treatment of Systemic Mastocytosis|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2012|
Patient will be treat at a starting dose of 20mg once daily, that can be escalated up to 100mg once daily.
Starting dosage 20mg once daily, that can be escalated up to 100mg once daily. Patient will remain on treatment for 12 months.
Other Name: BMS-354825-03
- To assess the clinical response rate in terms of both B/C findings and mediator-related symptoms in subjects with SM who have been treated with dasatinib. [ Time Frame: December 2011 ]
- To assess of the Time to Response (TTR), Duration of Response (DOR) and Progression-Free survival (PFS). [ Time Frame: December 2012 ]
- To evaluate the changes in specific biological markers and molecular mutations. [ Time Frame: June 2012 ]
- To evaluate the safety and toxicity of dasatinib in this population. [ Time Frame: December 2011 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979160
|Contact: Massimo Triggiani, firstname.lastname@example.org|
|Istituto di ematologia "L e A Seragnoli" - Policlinico universitario Sant'Orsola-Malpighi||Not yet recruiting|
|Bologna, Italy, 40138|
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|Pavia, Italy, 27100|
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|Verona, Italy, 37134|
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|Principal Investigator:||Massimo Triggiani, MD||Università Federico II|