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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
University of South Alabama
Mobile, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
Arizona Clinical Research Center
Tuscon, Arizona, United States
6-month Progression-free survival
Time frame: After the last non-progressing subject completes 6 months or discontinues the treatment
Objective response rate (proportion of subjects with complete response or partial response)
Time frame: After the last non-progressing subject completes 6 months or discontinues the treatment
1 year survival
Time frame: After the last non-progressing subject completes 6 months or discontinues the treatment
Overall survival
Time frame: 2 years after the last subject discontinues treatment
Duration of response
Time frame: After the last non-progressing subject completes 6 months or discontinues the treatment
Clinical benefit rate
Time frame: After the last non-progressing subject completes 6 months or discontinues the treatment
Time to response
Time frame: After the last non-progressing subject completes 6 months or discontinues the treatment
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Time frame: Monthly
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The Angeles Clinic and Research
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Redwood Regional Medical Group
Sebastopol, California, United States
University of Colorado
Aurora, Colorado, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Univ. of Michigan Health System
Ann Arbor, Michigan, United States
Univ. of Michigan Health System
Ann Arbor, Michigan, United States
...and 3 more locations