Melanoma
Conditions
Keywords
Melanoma, Stage III, Melanoma, Stage IV, YM 155, Metastatic Melanoma
Brief summary
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.
Detailed description
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.
Interventions
DRUGYM155
intravenous infusion
DRUGDocetaxel
intravenous infusion
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month Progression-free survival | After the last non-progressing subject completes 6 months or discontinues the treatment |
Secondary
| Measure | Time frame |
|---|---|
| 1 year survival | After the last non-progressing subject completes 6 months or discontinues the treatment |
| Overall survival | 2 years after the last subject discontinues treatment |
| Duration of response | After the last non-progressing subject completes 6 months or discontinues the treatment |
| Objective response rate (proportion of subjects with complete response or partial response) | After the last non-progressing subject completes 6 months or discontinues the treatment |
| Time to response | After the last non-progressing subject completes 6 months or discontinues the treatment |
| Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) | Monthly |
| Clinical benefit rate | After the last non-progressing subject completes 6 months or discontinues the treatment |
Countries
Canada, United States
Outcome results
None listed