临床试验/NCT00712504

NCT00712504已完成1 期

A Phase 1 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Solid Tumors

Pfizer1 个研究点分布在 1 个国家目标入组 49 人开始时间: 2004年7月最近更新: 2008年11月11日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Pfizer
入组人数: 49
试验地点: 1
主要终点: Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be tested in patients with advanced solid tumors, including non small cell lung cancer.

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

•Advanced solid tumor malignancy ECOG 0 or 1

排除标准

•Prior treatment with with high-dose chemotherapy requiring stem cell rescue Prior irradiation to ≥25% of the bone marrow (e.g. whole pelvis=25%) Patients with centrally located lung lesions unless recently treated with radiotherapy

研究组 & 干预措施

1

Experimental

SU011248 in combination with docetaxel

干预措施: sunitinib (Drug)

1

Experimental

SU011248 in combination with docetaxel

干预措施: docetaxel (Drug)

结局指标

主要结局

Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities

时间窗: November 2007

次要结局

Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), and docetaxel.(November 2007)
Objective disease response(November 2007)

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (1)

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