NCT01001936已完成1 期
Phase 1 Does-escalation Study of Oral SKI-606 in Subjects With Advanced Malignant Solid Tumors
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 28 人开始时间: 2006年2月最近更新:
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
- 28
- 主要终点
- Safety as measured by AE information. Tolerability as measured by DLT observation.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of oral SKI-606 (100, 200, 300 or 400 mg) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population. This study will also obtain preliminary information on the pharmacokinetics and antitumor activity of orally administered SKI-606 in subjects with advanced malignant solid tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available
- •Recovery from acute adverse effects of prior therapies to £ Grade 1 (excluding alopecia)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- •Adequate hepatic, renal, and bone marrow function
- •Age 20 to 74 years
- •Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control for the duration of the study and for 6 months and 30 days after the last dose of test article for male and female, respectively
- •Life expectancy of at least 12 weeks
排除标准
- •Use of any systemic antitumor agents or any investigational agent within 28 days before the enrollment (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
- •Ongoing clinical requirement for administration of a strong inhibitor of CYP3A4
- •Prior exposure to SKI-606 or any other Src-kinase inhibitor
- •Major surgery or radiotherapy within 2 weeks before the enrollment (recovery from previous surgery should be complete before day 1)
- •Subjects unable or unwilling to swallow SKI-606 capsules
- •Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth
- •Recent or ongoing clinically-significant gastrointestinal disorder
- •Pregnant or breastfeeding women
- •Subjects who meet the following criteria:
- •Evidence of serious active infection, significant medical or psychiatric illness
- •History of unexplained syncope or known ventricular arrythmia
- •Known seropositivity to HIV, or current or chronic Hepatitis B or Hepatitis hepatitis C
- •Hypokalemia
- •Unstable concurrent medical conditions
- •Any other condition that, in the investigator's judgment, make the subject inappropriate for this study the subject inappropriate for this study
研究组 & 干预措施
1
Experimental
干预措施: SKI-606 (Drug)
结局指标
主要结局
Safety as measured by AE information. Tolerability as measured by DLT observation.
时间窗: 2 years
次要结局
- Pharmacokinetics as measured by Taylor Technology Antitumor activity as measured by RECIST(2 years)
研究者
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