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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate

Outcome Time Frame:

6 cycles

Principal Investigator

D. Buell, MD

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma US, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

155-CL-008

NCT ID:

NCT00281541

Start Date:

November 2005

Completion Date:

June 2007

Related Keywords:

  • Melanoma
  • Treatment Efficacy
  • Treatment Effectiveness
  • Disease Management
  • Treatment
  • Safety
  • Malignant Melanoma
  • Melanoma

Name

Location
Albany, Georgia  31701
Phoenix, Arizona  85012
Philadelphia, Pennsylvania  19104
Little Rock, Arkansas  72205-7199
Hackensack, New Jersey  07601
Denver, Colorado  
Charlotte, North Carolina  
Washington, District of Columbia  
Salt Lake City, Utah  84112