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Completed

NCT Number: NCT00281541

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

A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tuscon, Arizona, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YM155

Drug

Primary outcomes

  1. Tumor response rate

    Time frame: 6 cycles

Secondary outcomes

  1. Duration of response

    Time frame: 6 cycles

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Official study title

A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma

Important dates

Study start
2005
Study completion
2007
First posted
Jan 25, 2006
Registry last updated
Jun 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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