NCT01009775
已完成
2 期
A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
概览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 11
- 主要终点
- 6-month Progression-free survival
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
YM155 plus docetaxel
Experimental
干预措施: YM155 (Drug)
YM155 plus docetaxel
Experimental
干预措施: Docetaxel (Drug)
结局指标
主要结局
6-month Progression-free survival
时间窗: After the last non-progressing subject completes 6 months or discontinues the treatment
次要结局
- 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)
- 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)
- Duration of response(After the last non-progressing subject completes 6 months or discontinues the treatment)
- Clinical benefit rate(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)
研究者
研究点 (11)
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