Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
All subjects will receive YM155 and docetaxel given in a 21-day cycle. The docetaxel dose will be established based on the findings of the lead-in portion of the study (Part 1). Once the docetaxel dose is established, Part 2 enrollment will begin.
Part 1:
Part 1 is a lead-in stage that will confirm if YM155 can be safely administered in combination with docetaxel at a specified dose.
Part 2:
Subjects enrolled in Part 2 will receive YM155 and docetaxel at the dose established during Part 1.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
