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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00281541

Collaborator

Astellas Pharma US, Inc. (Industry)

Enrollment

Locations

Duration (Months)

3.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: YM155	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

29 participants

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

Study Start Date :

Nov 1, 2005

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Tumor response rate [6 cycles]

Secondary Outcome Measures

Duration of response [6 cycles]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Tuscon	Arizona	United States	85724
2	Little Rock	Arkansas	United States	72205
3	Aurora	Colorado	United States	80045
4	Washington	District of Columbia	United States	20010
5	Atlanta	Georgia	United States	30322
6	Montclair	New Jersey	United States	07042
7	Winston-Salem	North Carolina	United States	27157
8	Pittsburgh	Pennsylvania	United States	15213
9	Salt Lake City	Utah	United States	84112