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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Prostate Cancer, Melanoma, Non-Hodgkin's Lymphoma

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess Response Rate

Outcome Time Frame:

End of Study

Safety Issue:

No

Principal Investigator

Sr. Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

155-CL-101

NCT ID:

NCT00818480

Start Date:

February 2006

Completion Date:

August 2012

Related Keywords:

  • Prostate Cancer
  • Melanoma
  • Non-Hodgkin's Lymphoma
  • prostate cancer
  • melanoma
  • lymphoma
  • YM155
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Melanoma
  • Prostatic Neoplasms

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