Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- AEs, laboratory parameters.
研究概览
简要总结
This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •adult patients, >=18 years of age;
- •advanced and/or metastatic solid tumor malignancy;
- •measurable or evaluable disease;
- •ECOG performance status 0 or 1.
排除标准
- •prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
- •prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures;
- •major surgery within 28 days of first receipt of study drug.
研究组 & 干预措施
1
干预措施: RG4733 (Drug)
2
干预措施: RG4733 (Drug)
3
干预措施: RG4733 (Drug)
结局指标
主要结局
AEs, laboratory parameters.
时间窗: Throughout study
次要结局
- Tumor assessments(day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter)
- Pharmacokinetic profile(After first dose and last dose (or day 15) of cycles 1 and 2)