Melanoma, Non-Hodgkin's Lymphoma, Prostate Cancer
Conditions
Keywords
prostate cancer, melanoma, lymphoma, YM155
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 eligible after completing the previous study.
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 I or phase II YM155 study.
Interventions
DRUGYM155
continuous infusion
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess Response Rate | End of Study up to 77 months |
| Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) | End of Study up to 77 months |
Countries
United States
Outcome results
None listed