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临床试验/NCT01562197
NCT01562197已完成2 期

A Randomized Phase II Clinical Trial on the Efficacy of Axitinib as a Monotherapy or in Combination With Lomustine for the Treatment of Patients With Recurrent Glioblastoma

Bart Neyns1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
anti-tumor effect of axitinib as a single therapeutic agent and in combination with Lomustine

研究概览

简要总结

This clinical trial will recruit patients diagnosed with glioblastoma at the time of recurrence or progression following prior treatment with surgery, radiation therapy and alkylating chemotherapy. Patients will be screened and if found eligible will be randomized to one of two treatment arms (1:1 randomization). Patients randomized to the Axitinib treatment-arm will be treated with Axitinib until progression (they can be treated after progression in the Axitinib plus lomustine arm), unacceptable treatment related toxicity, or patients refusal to continue study treatment. Patients randomized to the Axitinib plus Lomustine-arm will receive treatment until progression, unacceptable treatment related toxicity, or patients refusal to continue study treatment.

研究设计

研究类型
Interventional
分配方式
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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Axitinib

Experimental

axitinib treatment arm

干预措施: axitinib (Drug)

Axitinib plus Lomustine

Experimental

Axitinib plus Lomustine

干预措施: Axitinib plus Lomustine (Drug)

结局指标

主要结局

anti-tumor effect of axitinib as a single therapeutic agent and in combination with Lomustine

时间窗: 6months

To estimate the anti-tumor effect of axitinib as a single therapeutic agent for the treatment of glioblastoma patients at the time of recurrence/progression following prior surgery, radiation and alkylating chemotherapy and in combination with Lomustine

次要结局

未报告次要终点

研究者

发起方
Bart Neyns
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bart Neyns

MD PhD

Universitair Ziekenhuis Brussel

研究点 (1)

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