A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Melanoma
Both
Melanoma
Trial Information
A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma
A phase II, multicenter, open-label study in subjects with unresectable Stage III or
metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155
Inclusion Criteria:
- Histologically or cytologically confirmed unresectable stage III or IV malignant
melanoma
- Life expectancy >12 weeks
Exclusion Criteria:
- History of other malignancy in the last 5 years
- Major surgery within the past 21 days
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor response rate
Outcome Time Frame:
6 cycles
Principal Investigator
D. Buell, MD
Investigator Role:
Study Director
Investigator Affiliation:
Astellas Pharma US, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
155-CL-008
NCT ID:
NCT00281541
Start Date:
November 2005
Completion Date:
June 2007
Related Keywords:
- Melanoma
- Treatment Efficacy
- Treatment Effectiveness
- Disease Management
- Treatment
- Safety
- Malignant Melanoma
- Melanoma
Name | Location |
|---|---|
| Albany, Georgia 31701 | |
| Phoenix, Arizona 85012 | |
| Philadelphia, Pennsylvania 19104 | |
| Little Rock, Arkansas 72205-7199 | |
| Hackensack, New Jersey 07601 | |
| Denver, Colorado | |
| Charlotte, North Carolina | |
| Washington, District of Columbia | |
| Salt Lake City, Utah 84112 |
