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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Melanoma Non-Hodgkin's Lymphoma Drug: YM155 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1. YM155 Drug: YM155
continuous infusion


Outcome Measures
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Primary Outcome Measures :
  1. Assess Response Rate [ Time Frame: End of Study up to 77 months ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00818480


Locations
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United States, Texas
Institute for Drug Development
San Antonio, Texas, United States, 78229
South Texas Accelerated
San Antonio, Texas, United States, 78229
United States, Utah
Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Sr. Medical Director Astellas Pharma Global Development
More Information
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00818480    
Other Study ID Numbers: 155-CL-101
First Posted: January 7, 2009    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: August 2015
Keywords provided by Astellas Pharma Inc:
prostate cancer
melanoma
lymphoma
YM155
Additional relevant MeSH terms:
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Prostatic Neoplasms
Melanoma
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Prostatic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas