The purpose of this study is to:
Phase I Objectives:
- Find the most tolerated dose to use for Phase II
- Collect information on how the body responds to this combination of study drug
Phase II Objectives:
- To determine the overall response of participants using this combination of study drug
The expression of proto-oncogene tyrosine-protein kinase (Src), a substance present in a
significant proportion of melanomas plays a role in the growth, multiplying, and dividing of
cancer cells. Melanoma cells appear to be sensitive to these agents that block the action of
Src in concentrations that can be achieved in patients. We suggest that Src inhibitors (such
as Dasatinib) may be a good choice for treatment of melanoma in combination with Dacarbazine
(a chemotherapy drug that can cause the shrinkage of melanomas). We wish to to evaluate the
Src inhibitor Dasatinib in combination with the chemotherapy drug Dacarbazine. The novel oral
Src inhibitor Dasatinib may be able to increase the effectiveness of chemotherapy for
melanoma compared to chemotherapy alone. Dacarbazine is a standard treatment for melanoma
currently. The effectiveness of this chemotherapy drug may be increased by combination with
Dasatinib. Dacarbazine has been approved by the US Food and Drug Administration (FDA) for
treating melanoma; Dasatinib has been approved by the FDA to treat leukemia, but it has not
been approved alone or in combination with Dacarbazine to treat melanoma.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute