Melanoma Clinical Trial
Official title:
A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
The purpose of the study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel in subjects with Stage III (unresectable) and Stage IV melanoma.
All subjects will receive YM155 and docetaxel given in a 21-day cycle. The docetaxel dose
will be established based on the findings of the lead-in portion of the study (Part 1). Once
the docetaxel dose is established, Part 2 enrollment will begin.
Part 1:
Part 1 is a lead-in stage that will confirm if YM155 can be safely administered in
combination with docetaxel at a specified dose.
Part 2:
Subjects enrolled in Part 2 will receive YM155 and docetaxel at the dose established during
Part 1.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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