Back to resultsAn Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155
Primary Purpose
Prostate Cancer, Melanoma, Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
YM155
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, melanoma, lymphoma, YM155
Eligibility 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
Sites / Locations
- Institute for Drug Development
- South Texas Accelerated
- Huntsman Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1. YM155
Arm Description
Outcomes
Primary Outcome Measures
Assess Response Rate
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00818480
Brief Title
An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Melanoma, Non-Hodgkin's Lymphoma
Keywords
prostate cancer, melanoma, lymphoma, YM155
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. YM155
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
YM155
Intervention Description
continuous infusion
Primary Outcome Measure Information:
Title
Assess Response Rate
Time Frame
End of Study up to 77 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
Institute for Drug Development
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
South Texas Accelerated
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
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An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155
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