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

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ClinicalTrials.gov Identifier: NCT00818480
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : September 4, 2015
Information provided by (Responsible Party):
Astellas Pharma Inc

January 6, 2009
January 7, 2009
September 4, 2015
February 2006
March 2011   (Final data collection date for primary outcome measure)
  • Assess Response Rate [ Time Frame: End of Study up to 77 months ]
  • Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) [ Time Frame: End of Study up to 77 months ]
  • Assess Response Rate [ Time Frame: End of Study ]
  • Evaluation of safety parameters [ Time Frame: End of Study ]
Complete list of historical versions of study NCT00818480 on ClinicalTrials.gov Archive Site
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An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155
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.

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Prostate Cancer
  • Melanoma
  • Non-Hodgkin's Lymphoma
Drug: YM155
continuous infusion
Experimental: 1. YM155
Intervention: Drug: YM155
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2012
March 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Sr. Medical Director Astellas Pharma Global Development
Astellas Pharma Inc
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP