Evaluation of Response of Dasatinib to Treat Mastocytosis
Recruitment status was: Not yet recruiting
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).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Open-Label, Single Arm Phase II Clinical Trial of Dasatinib in the Treatment of Systemic Mastocytosis|
- 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 ] [ Designated as safety issue: No ]
- To assess of the Time to Response (TTR), Duration of Response (DOR) and Progression-Free survival (PFS). [ Time Frame: December 2012 ] [ Designated as safety issue: No ]
- To evaluate the changes in specific biological markers and molecular mutations. [ Time Frame: June 2012 ] [ Designated as safety issue: No ]
- To evaluate the safety and toxicity of dasatinib in this population. [ Time Frame: December 2011 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979160
|Istituto di ematologia "L e A Seragnoli" - Policlinico universitario Sant'Orsola-Malpighi|
|Bologna, Italy, 40138|
|Dipartimento di Ematologia - S.O.D. di Ematologia Università degli Studi di Firenze - Azienda Ospedaliera Careggi|
|Firenze, Italy, 50134|
|Divisione di Ematologia Ospedale Niguarda Ca' Grande|
|Milano, Italy, 20162|
|Divisione di Allergologia e Immunologia Clinica, Università Federico II|
|Napoli, Italy, 80131|
|Divisione di Ematologia Università di Torino Ospedale San Luigi Gonzaga|
|Orbassano (TO), Italy, 10043|
|Istituto di Ematologia Università degli Studi di Pavia - Policlinico S. Matteo IRCCS|
|Pavia, Italy, 27100|
|Unità di Ematologia e Trapianto Osseo CROB, Centro di Riferimento Oncologico di Basilicata +39 0972 726729 Fax +30 0972 726217 e-mail: firstname.lastname@example.org|
|Rionero in Vulture (Pz), Italy|
|Ematologia Tor Vergata University Hospital|
|Roma, Italy, 00133|
|Divisione di Ematologia Policlinico Universitario "Agostino Gemelli"|
|Roma, Italy, 00168|
|Ematologia e Trapianti Università degli Studi di Siena - Policlinico S. Maria alle Scotte|
|Siena, Italy, 53100|
|Divisione di Ematologia e Trapianto Midollo Osseo Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"|
|Udine, Italy, 33100|
|Sezione di Ematologia - Dipartimento di Medicina Clinica e Sperimentale Policlinico G.B.Rossi - Università degli Studi di Verona|
|Verona, Italy, 37134|
|Principal Investigator:||Massimo Triggiani, MD||Università Federico II|