Phase II: An Open-Label Extension Study of 168-Hour Continuous Infusion of YM155 in Subjects Previously Enrolled in a Phase I or Phase II Protocol Administering YM155
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 I or phase II YM155 study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess Response Rate
End of Study
No
Sr. Medical Director
Study Director
Astellas Pharma Global Development
United States: Food and Drug Administration
155-CL-101
NCT00818480
February 2006
August 2012
Name | Location |
---|---|
Institute for Drug Development | San Antonio, Texas 78245-3217 |
South Texas Accelerated | San Antonio, Texas 78229 |
Huntsman Cancer Hospital | Salt Lake City, Utah 84112 |