NCT00656461已完成1 期
Phase 1 Study of MKC-1 in Patients With Advanced or Metastatic Solid Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day (bid) continuously in patients with advanced or refractory solid tumors.
研究概览
简要总结
This is an open-label study to determine the highest dose of MKC-1 that may be administered daily on a continuous basis for patients with advanced or refractory 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective.
- •Age greater than or equal to 18 years.
- •ECOG performance status ≤1
- •ANC greater than or equal to 1,500/mm3;
- •Platelets greater than or equal to 100,000/mm3
- •creatinine ≤1.5 times institutional upper limit of normal (ULN)
- •T Bili within normal limits;
- •AST and ALT less than or equal to 2.5 times ULN; and
- •albumin greater than or equal to 3.0 g/dL
- •have measurable disease by RECIST, radiographically evaluable disease, or detectable disease
- •women of child-bearing potential and men must agree to use adequate contraception
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Have previously received MKC-
- •Have received radiation to greater than 25% of the bone marrow.
- •Have had anti-cancer therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- •Are concurrently receiving any other investigational agents while on study.
- •Have known brain metastases
- •Have any condition that impairs the ability to swallow and retain MKC-1 capsules.
- •Uncontrolled intercurrent illness
- •Are pregnant or breastfeeding
- •HIV-positive patients
- •Patients with uncontrolled diabetes
研究组 & 干预措施
1
Experimental
干预措施: MKC-1 (Drug)
结局指标
主要结局
Determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day (bid) continuously in patients with advanced or refractory solid tumors.
时间窗: Throughout study participation
次要结局
- Determine evidence of benefit in cancer patients when MKC-1 is administered orally twice a day (bid) continuously by evaluating tumor response and/or tumor marker improvement.(During study participation)
研究者
研究点 (1)
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