This is a combination Phase I/II design that explores the toxicity and activity of Sunitinib
and Dacarbazine (DTIC) for metastatic melanoma. The initial Phase I part of this trial will
consist of a dose escalation of sunitinib while keeping the DTIC dose constant. If no DLT is
seen, this dose will be the suggested Phase II trial dose. If less than 2 disease responses
are seen, patients will not be enrolled any further, and the study will be considered
negative for activity. If a clinical response is seen, patients will continue to be enrolled.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute