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A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00281541
First Posted: January 25, 2006
Last Update Posted: June 7, 2012
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.
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
  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
Intervention Model: Single Group Assignment
Masking: None (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
Detailed Description:
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

ClinicalTrials.gov Identifier: NCT00281541     History of Changes
Other Study ID Numbers: 155-CL-008
First Submitted: January 23, 2006
First Posted: January 25, 2006
Last Update Posted: June 7, 2012
Last Verified: June 2012

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