Spots Global Cancer Trial Database for A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
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Trial Identification
Brief Title: A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
Official Title: A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
Study ID: NCT01009775
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of South Alabama, Mobile, Alabama, United States
University of South Alabama, Mobile, Alabama, United States
Arizona Clinical Research Center, Tuscon, Arizona, United States
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
St. Lukes Hospital Cancer Center, Bethlehem, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
London Regional Cancer Centre, London, Ontario, Canada
Contact Details
Name: Sr. Medical Director
Affiliation: Astellas Pharma Global Development
Role: STUDY_DIRECTOR
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