Stage III (Unresectable) or Stage IV Melanoma. MedDRA version: 12.0 Level: LLT Classification code 10025670 Term: Malignant melanoma stage III MedDRA version: 12.0 Level: LLT Classification code 10025671 Term: Malignant melanoma stage IV
Conditions
Sponsors
Astellas Pharma Global Development, Inc. (APGD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject is eligible for the study if all of the following apply: 1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). 2. Male or female subjects aged 18 years or older at the Baseline Visit. 3. Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the Baseline Visit. 5. No prior systemic treatment for advanced melanoma (Stage III or Stage IV). Treatment with a kinase inhibitor, biologic therapy, vaccine or investigational treatment for unknown primary melanoma is allowed if administered in the adjuvant setting > 4 weeks prior to the Baseline Visit. Treatment with an immunotherapy is allowed if administered > 6 weeks prior to the Baseline Visit. 6. Completion of palliative radiation treatment if administered > 4 weeks prior to the Baseline Visit. 7. At least one measurable target lesion according to RECIST (Version 1.1). o If the lesion received prior radiation, there must be evidence of disease progression since last radiated. 8. Subjects with a previous history of non-melanoma malignancy are eligible for this study only if the subject meets the following criteria for a cancer survivor: o The subject has undergone potentially curative therapy for all prior malignancies including basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix. o The subject has been considered disease free for at least 5 years. 9. Life expectancy > 12 weeks at the Baseline Visit. 10. If the subject is female, she must be non-pregnant and non-lactating. Each site will administer a pregnancy test to any female of childbearing potential during the Screening Period and at the Baseline Visit. Only females with negative pregnancy test results will be eligible. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will be excluded from participation if any of the following apply: 1. Major surgery within 21 days of the Baseline Visit. 2. Presence of brain metastases. 3. Previously treated with YM155. 4. Primary ocular, choroidal or mucosal melanoma. 5. Neuropathy > Grade 2 at Baseline Visit. 6. Inadequate marrow, hepatic and/or renal function at the Baseline Visit defined as: o Serum creatinine > 1.5 x upper limit of normal (ULN) or calculated serum creatinine clearance 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN. o Bilirubin > ULN. 7. The subject has significant and/or uncontrolled cardiac, renal, hepatic or other systemic disorders, deep tissue infections or significant psychological conditions at Baseline Visit that in the Investigator’s judgment would jeopardize subject enrollment or compliance with the study procedures. 8. Hypersensitivity to docetaxel or polysorbate 80. 9. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate 6-month Progression Free Survival (PFS).;Secondary Objective: To evaluate the following: • Objective Response Rate (ORR). • 1-year Survival. • Overall Survival (OS). • Duration of Response (DOR). • Clinical Benefit Rate (CBR). • Time to Response (TTR). • Safety and tolerability of YM155 given in combination with docetaxel.;Primary end point(s): The primary endpoint for the study is progression free survival (PFS). The 6-month PFS is defined as the probability that a patient survives without objective tumor progression at 6 months (24 weeks) following the first dose of study regimen. Objective tumor progression is assessed by the independent radiological review. | — |
Countries
France
Outcome results
None listed