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

This study has been completed.
Sponsor:
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
  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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014