Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin

Myrexis Inc.5 个研究点分布在 1 个国家目标入组 30 人开始时间: 2008年3月1日最近更新: 2011年3月25日

适应症

试验速览

阶段: 1 期
发起方: Myrexis Inc.
入组人数: 30
试验地点: 5
主要终点: Maximum tolerated dose

研究概览研究设计入排标准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 is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with carboplatin.

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

•Histologically proven WHO Grade IV glioblastoma multiforme at time of diagnosis or relapse
•Prior treatment with radiotherapy and temozolomide
•Evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI
•Be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU)
•Have a Performance Scale of Karnofsky > 60%, ECOG < 2 or WHO < 2
•If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week

排除标准

•Hypersensitivity to Cremophor EL
•Have evidence of current/active intratumor hemorrhage by MRI
•Have greater than second relapse
•Have had prior treatment with platinum-based chemotherapy
•Have cardiovascular disease
•Have cerebrovascular disease
•Have uncontrolled hypertension
•Have a cardiac ejection fraction < 50%
•Have Troponin-I elevated above the normal range

结局指标

主要结局

Maximum tolerated dose

时间窗: After each cohort is enrolled and all subjects have completed 1 cycle

次要结局

Pharmacokinetics(Cycle 1 only)
Antitumor activity(Screening, end of each cycle, end of study)

研究者

发起方

Myrexis Inc.

申办方类型

Industry

研究点 (5)

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