A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma

Completed · Phase 2

Conditions studied: Melanoma

In brief

The purpose of the study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel in subjects with Stage III (unresectable) and Stage IV melanoma.

Key facts

Study ID

NCT01009775

Run by

Astellas Pharma Inc

People needed

64

Starts

2009-11-01

Expected to finish

2012-08-01

Last updated by the study team

2015-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma
• No prior systemic treatment or Cytotoxic chemotherapy for advanced melanoma (Stage III or Stage IV)
• If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
• Eastern Cooperative Oncology Group (ECOG) performance status </= 1
• Life expectancy > 12 weeks
• At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors ({RECIST} version 1.1)
• Subjects with a previous history of non-melanoma malignancy must have undergone curative therapy for all prior malignancies and be considered disease free for at least 5 years

You may not qualify if…

• Major surgery within 21 days of the Baseline Visit
• Presence or history of brain metastases
• Primary ocular, choroidal or mucosal melanoma
• Known history of positive test for Hepatitis B surface Antigen (HsbAg) or Hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV)
• Hypersensitivity to docetaxel or polysorbate 80
• Neuropathy greater than or equal to Grade 2 at Baseline Visit
• The subject has been previously treated with YM155
• Inadequate marrow, hepatic, and/or renal functions

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• University of South Alabama — Mobile, Alabama, United States
• Arizona Clinical Research Center — Tuscon, Arizona, United States
• The Angeles Clinic and Research — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• Redwood Regional Medical Group — Sebastopol, California, United States
• University of Colorado — Aurora, Colorado, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Univ. of Michigan Health System — Ann Arbor, Michigan, United States
• Univ. of Michigan Health System — Ann Arbor, Michigan, United States
• St. Lukes Hospital Cancer Center — Bethlehem, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• London Regional Cancer Centre — London, Ontario, Canada

Full record on ClinicalTrials.gov

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