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NCT00281541 Clinical Trial

A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma

Melanoma Clinical Trial

Official title:
A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00281541
Other study ID # 155-CL-008
Secondary ID
Status Completed
Phase Phase 2
First received January 23, 2006
Last updated June 6, 2012
Start date November 2005
Est. completion date June 2007

Study information
Verified date June 2012
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.

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

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• YM155

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tumor response rate 6 cycles
Secondary Duration of response 6 cycles
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