A Phase 2 Study of Dasatinib in Advanced Melanoma
I. Determine the objective response rate in patients with stage III unresectable or stage IV
melanoma treated with dasatinib.
II. Determine the progression-free survival of patients treated with this drug.
I. To assess the expression of targets of Dasatinib prior to treatment by obtaining
pre-treatment biopsies or examining paraffin-embedded tissues from previous tumor
II. In selected patients (approximately 5-10) where tumor tissue is available pre-treatment
and can be obtained post-treatment with Dasatinib (21 days after initiation of therapy), to
determine if Dasatinib induces changes in expression of selected targets and downstream
mediators, including MEK, ERK and RSK-1.
III. To assess toxicity.
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (partial response and complete response) as measured by RECIST criteria
Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon's optimum two-stage design will be used.
After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment
United States: Food and Drug Administration
|Yale University||New Haven, Connecticut 06520|
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|