Back to resultsA Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
YM155
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety, Malignant Melanoma
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Tumor response rate
Secondary Outcome Measures
Duration of response
Full Information
NCT ID
NCT00281541
First Posted
January 23, 2006
Last Updated
June 6, 2012
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00281541
Brief Title
A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma
Official Title
A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety, Malignant Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
YM155
Primary Outcome Measure Information:
Title
Tumor response rate
Time Frame
6 cycles
Secondary Outcome Measure Information:
Title
Duration of response
Time Frame
6 cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. Buell, MD
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma
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