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临床试验/NCT00400296
NCT00400296已完成1 期

A Multiple Ascending Dose (MAD) Study of R547 Administered as an Intravenous Infusion on a Weekly Schedule in Patients With Advanced Solid Tumors

Hoffmann-La Roche0 个研究点目标入组 58 人开始时间: 2005年5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
入组人数
58
主要终点
AEs, laboratory parameters.

研究概览

简要总结

This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is <100 individuals.

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

  • •adult patients, >=18 years of age;
  • •locally advanced or metastatic solid tumors;
  • •measurable or evaluable disease.

排除标准

  • •prior chemotherapy, radiotherapy or immunotherapy within 3 weeks of start of study;
  • •prior history of CNS metastases with disease progression;
  • •patients taking strong inhibitors and/or inducers of CYP3A4.

研究组 & 干预措施

1

Experimental

干预措施: RG547 (Drug)

结局指标

主要结局

AEs, laboratory parameters.

时间窗: Throughout study

次要结局

  • Pharmacokinetic and pharmacodynamic profiles of R547(Throughout study)

研究者

申办方类型
Industry
责任方
Sponsor

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