跳至主要内容
临床试验/NCT01470794
NCT01470794已完成1 期

A Phase 1 Ascending Dose Trial of Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered to Subjects at the Time of Resection for Recurrent High Grade Glioma & Followed by Treatment With Toca FC, Extended-Release 5-FC

Tocagen Inc.8 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2012年2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
发起方
Tocagen Inc.
入组人数
58
试验地点
8
主要终点
Dose Limiting Toxicities

研究概览

简要总结

This is a multicenter study evaluating the safety and tolerability of increasing doses of Toca 511, a retroviral replicating vector, injected into the resection cavity of patients with Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their tumor. Approximately 6 weeks after injection of Toca 511, patients will begin an oral courses of Toca FC, an antifungal agent. These one week courses of Toca FC will be repeated during the approximately 30 week study. Two separate cohorts of patients treated with Toca 511 and Toca FC will also be evaluated with either of the following standard treatments for glioma: lomustine or bevacizumab. After completion of this study, all patients will be eligible for enrollment and encouraged to enter a long-term continuation protocol that enables additional Toca FC treatment cycles to be given, as well as permits the collection of long-term safety and survival data.

研究设计

研究类型
Interventional
分配方式
Na
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 80 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

Single Arm

Experimental

Toca 511 vector/Toca FC prodrug

干预措施: Toca 511 vector (Biological)

Single Arm

Experimental

Toca 511 vector/Toca FC prodrug

干预措施: Toca FC (Drug)

结局指标

主要结局

Dose Limiting Toxicities

时间窗: 2 months

Excluding nausea, vomiting and fatigue, any Grade 3 or higher non-hematologic toxicity or any Grade 4 or higher hematologic toxicity, felt to be related to Toca 511 or the Toca 511/Toca FC combination.

次要结局

  • Overall Survival of Subjects(Overall survival, Overall survival at 6 months (OS6), 9 months (OS9), and 12 months (OS12))
  • Progression Free Survival (PFS) of Subjects(PFS of subjects at 6 months (PFS-6))

研究者

发起方
Tocagen Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (8)

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