An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00818480
First received: January 6, 2009
Last updated: September 26, 2012
Last verified: September 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Melanoma Non-Hodgkin's Lymphoma |
Drug: YM155 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Assess Response Rate [ Time Frame: End of Study ] [ Designated as safety issue: No ]
- Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) [ Time Frame: End of Study ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | February 2006 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1. YM155 |
Drug: YM155
continuous infusion
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818480
Locations
| 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
| Study Director: | Sr. Medical Director | Astellas Pharma Global Development |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00818480 History of Changes |
| Other Study ID Numbers: | 155-CL-101 |
| Study First Received: | January 6, 2009 |
| Last Updated: | September 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
prostate cancer melanoma lymphoma YM155 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Melanoma Prostatic Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013