A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- maximum tolerated dose
研究概览
简要总结
A study of sequential administration of oral sapacitabine and oral Seliciclib in patients with advanced solid tumors.
详细描述
The primary objective of this study is to determine the maximum tolerated dose (MTD) or recommended phase II doses of sapacitabine and seliciclib administered sequentially or concomitantly. The secondary objectives are to evaluate antitumor activity of this sequential or concomitant treatment and to explore the pharmacodynamic effect of this treatment in skin and peripheral blood mononuclear cells.
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
- •Incurable advanced solid tumors that are no longer responding to conventional therapy or for which no effective therapy exists; at the RD of Part 1, an extension cohort up to 20 patients with metastatic breast cancer who are known to be BRCA mutation carriers will be enrolled.
- •Age 18 years or older
- •Life expectancy ≥ 3 months
- •Evaluable disease
- •Adequate bone marrow function
- •Adequate renal function
- •Adequate liver function
- •At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
- •Able to swallow capsules
- •At least 3 weeks from major surgery
- •Agree to practice effective contraception
- •Ability to understand and willingness to sign the informed consent form
排除标准
- •Previously untreated CNS metastases or progressive CNS metastases
- •Currently receiving radiotherapy, biological therapy, or any other investigational agents
- •Uncontrolled intercurrent illness including
- •Pregnant or lactating women
- •Known to be HIV-positive
- •A history of active hepatitis B and/or hepatitis C infection
研究组 & 干预措施
sapacitabine and seliciclib
Sequential or concomitant administration of sapacitabine and seliciclib
干预措施: sapacitabine and seliciclib (Drug)
结局指标
主要结局
maximum tolerated dose
时间窗: 1-3 months
MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients
次要结局
- tumor response rate(1-3 months)
- pharmacodynamic effects in skin and peripheral mononuclear cells(1-3 months)