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

Phase 2

Completed

• Conditions: Melanoma

• Registration Number: NCT00281541
• Lead Sponsor: Astellas Pharma Inc

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 Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-01-23
• Study First Submitted QC: 2006-01-23
• Study First Posted: 2006-01-25
• Study Completion: 2007-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tumor response rate	6 cycles

Secondary Outcome Measures

Name	Time	Method
Duration of response	6 cycles