Status:
COMPLETED
An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Prostate Cancer
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This protocol is open to subjects previously enrolled in and who had completed a Phase I or Phase II study administering YM155. Subjects who are receiving benefit from treatment with YM155 are eligibl...
Detailed Description
The main objective of the study is to continue to evaluate the safety and efficacy of YM155. Each subject will be treated at the dose he/she was receiving at the completion of his/her previous phase ...
Eligibility Criteria
Inclusion
- Completed a Phase I or II YM155 study with at least stable disease and continues to meet the criteria as stated in the previous YM155 study that allows for additional treatment with YM155
- Lack of progression based on the most recent radiological imaging, biochemical assessments and/or physical examination
- Negative pregnancy test result (females of child-bearing potential)
Exclusion
- More than 21 days (or 14 days depending on the study of origin) between the time the last infusion of YM155 was stopped in the previous study and the proposed start of the first infusion in this study
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00818480
Start Date
February 1 2006
End Date
August 1 2012
Last Update
September 4 2015
Active Locations (3)
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1
Institute for Drug Development
San Antonio, Texas, United States, 78229
2
South Texas Accelerated
San Antonio, Texas, United States, 78229
3
Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84112