Overview

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

Status:
Completed

Trial end date:
2012-08-01

Target enrollment:
0

Participant gender:
All

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 eligible after completing the previous study.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Astellas Pharma Inc

Criteria

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