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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Starting dosage 20mg once daily, that can be escalated up to 100mg once daily. Patient will remain on treatment for 12 months.
Istituto di ematologia "L e A Seragnoli" - Policlinico universitario Sant'Orsola-Malpighi
Bologna, Italy
Dipartimento di Ematologia - S.O.D. di Ematologia Università degli Studi di Firenze - Azienda Ospedaliera Careggi
Florence, Italy
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Divisione di Ematologia Ospedale Niguarda Ca' Grande
Milan, Italy
Divisione di Allergologia e Immunologia Clinica, Università Federico II
Napoli, Italy
Divisione di Ematologia Università di Torino Ospedale San Luigi Gonzaga
Orbassano (TO), Italy
Istituto di Ematologia Università degli Studi di Pavia - Policlinico S. Matteo IRCCS
Pavia, Italy
Unità di Ematologia e Trapianto Osseo CROB, Centro di Riferimento Oncologico di Basilicata +39 0972 726729 Fax +30 0972 726217 e-mail: p.musto@crob.it
Rionero in Vulture (Pz), Italy
Ematologia Tor Vergata University Hospital
Roma, Italy
Divisione di Ematologia Policlinico Universitario "Agostino Gemelli"
Roma, Italy
Ematologia e Trapianti Università degli Studi di Siena - Policlinico S. Maria alle Scotte
Siena, Italy
...and 2 more locations