A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
6-month Progression-free survival
After the last non-progressing subject completes 6 months or discontinues the treatment
No
Sr. Medical Director
Study Director
Astellas Pharma Global Development
United States: Food and Drug Administration
155-CL-034
NCT01009775
November 2009
August 2012
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
University of Colorado | Denver, Colorado 80217 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
UCLA | Los Angeles, California 90095 |
Redwood Regional Medical Group | Santa Rosa, California 95403 |
St. Lukes Hospital Cancer Center | Bethlehem, Pennsylvania 18015 |
University of South Alabama | Mobile, Alabama 36693 |
The Angeles Clinic and Research | Los Angeles, California 90025 |
Univ. of Michigan Health System | Ann Arbor, Michigan 48109/48109 |