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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00818480
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE January 6, 2009
First Posted Date  ICMJE January 7, 2009
Last Update Posted Date September 4, 2015
Study Start Date  ICMJE February 2006
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
  • Assess Response Rate [ Time Frame: End of Study ]
  • Evaluation of safety parameters [ Time Frame: End of Study ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Melanoma
  • Non-Hodgkin's Lymphoma
Intervention  ICMJE Drug: YM155
continuous infusion
Study Arms  ICMJE Experimental: 1. YM155
Intervention: Drug: YM155
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2010)		 10
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2009)		 100
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00818480
Other Study ID Numbers  ICMJE 155-CL-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Astellas Pharma Inc
Original Responsible Party Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc
Current Study Sponsor  ICMJE Astellas Pharma Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sr. Medical Director Astellas Pharma Global Development
PRS Account Astellas Pharma Inc
Verification Date August 2015

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