NCT00281541
Completed
Phase 2
A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 29
- Primary Endpoint
- Tumor response rate
Overview
Brief Summary
A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Tumor response rate
Time Frame: 6 cycles
Secondary Outcomes
- Duration of response(6 cycles)
Investigators
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