NCT02516527已完成1 期
A Phase 1 Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Subjects With Select Advanced Solid Tumors
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年10月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The safety of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths
研究概览
简要总结
The purpose of this study is to determine whether ipilimumab is effective in the treatment of select advanced (unresectable, metastatic, or recurrent) solid tumors in Chinese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Subjects with the following advanced solid tumors; metastatic or recurrent
- •Must have measurable/non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria.
- •Subjects have ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up
- •Chinese women and men, ages 18 years or older
排除标准
- •Subjects with brain metastases are excluded unless clinically stable for more than 4 weeks at the time of randomization as determined by the investigator
- •Subjects with ocular melanoma are excluded
- •Any other malignancy from which the subject has been free of disease for less than two years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- •History of, or currently active, autoimmune diseases, including but not limited to inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (eg, Guillain-Barre syndrome). Vitiligo is not excluded
- •Any current or history of immunodeficiency, splenectomy, or splenic radiation
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Induction Phase:Ipilimumab
Experimental
Ipilimumab dose as specified
干预措施: Ipilimumab (Drug)
Maintenance Phase:Ipilimumab
Experimental
Ipilimumab dose as specified
干预措施: Ipilimumab (Drug)
结局指标
主要结局
The safety of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths
时间窗: Up to 90 days post discontinuation of dosing
Identify dose limiting toxicities in Chinese subjects with select advanced (unresectable, metastatic, or recurrent) solid tumors measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation, and deaths
时间窗: Up to 90 days post discontinuation of dosing
The tolerability of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths
时间窗: Up to 90 days post discontinuation of dosing
次要结局
未报告次要终点
研究者
研究点 (1)
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