A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma
This study has been completed.
Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00281541
First received: January 23, 2006
Last updated: June 6, 2012
Last verified: June 2012
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Purpose
A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
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: | A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Tumor response rate [ Time Frame: 6 cycles ]
Secondary Outcome Measures:
- Duration of response [ Time Frame: 6 cycles ]
| Estimated Enrollment: | 29 |
| Study Start Date: | November 2005 |
| Study Completion Date: | June 2007 |
A phase II, multicenter, open-label study in subjects with unresectable Stage III or metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed unresectable stage III or IV malignant melanoma
- Life expectancy >12 weeks
Exclusion Criteria:
- History of other malignancy in the last 5 years
- Major surgery within the past 21 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281541
Locations
| United States, Arizona | |
| Tuscon, Arizona, United States, 85724 | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30322 | |
| United States, New Jersey | |
| Montclair, New Jersey, United States, 07042 | |
| United States, North Carolina | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Pennsylvania | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84112 | |
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Investigators
| Study Director: | D. Buell, MD | Astellas Pharma US, Inc. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00281541 History of Changes |
| Other Study ID Numbers: | 155-CL-008 |
| Study First Received: | January 23, 2006 |
| Last Updated: | June 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
Treatment Efficacy Treatment Effectiveness Disease Management |
Treatment Safety Malignant Melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 23, 2013