An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155

Status:	Completed
Conditions:	Prostate Cancer, Skin Cancer, Cancer, Lymphoma
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	February 2006
End Date:	August 2012

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

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 eligible after completing the previous study.

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.

Inclusion Criteria:

- 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 Criteria:

- 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

We found this trial at

sites

The Institute for Drug Development

San Antonio, Texas 78245

from

San Antonio, TX