EUCTR2009-015738-31-FR进行中（未招募）1 期
A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects with Stage III (Unresectable) or Stage IV Melanoma
Astellas Pharma Global Development, Inc. (APGD)0 个研究点目标入组 72 人开始时间: 2009年10月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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 < 60 mL/min.
- •o ANC < 1500/mm3.
- •o Platelet < 100,000/mm3.
- •o Alanine transaminase (ALT) and Aspartate transaminase (AST) > 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).
研究者
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