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临床试验/NCT02279602
NCT02279602已完成2 期

Rollover for Study OX4218s, A P2 Study to Investigate Safety and Activity of Fosbretabulin Tromethamine in the Treatment of Well-Differentiated, Low-to-Intermediate-Grade Unresectable, Recurrent or Metastatic PNET or GI-NET With Elevated Biomarkers

Mateon Therapeutics5 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2014年12月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
7
试验地点
5
主要终点
Change in biomarkers from baseline

研究概览

简要总结

Subjects achieving a clinical response in study OX4218s with a biomarker reduction or symptom response are eligible to enroll in this rollover study to continue once every three weeks fosbretabulin infusions for up to one year.

详细描述

Subjects enrolled in the PNET/GI-NET study OX4218s received weekly dosing with fosbretabulin for up to 3 cycles or approximately 9 weeks. Subjects achieving a clinical response with a biomarker reduction or symptom response based on investigator assessment are eligible to enroll in this rollover study (protocol OX4219s). Subjects will receive fosbretabulin every three weeks for a maximum of approximately one year or until disease progression, unacceptable toxicity, consent withdrawal, protocol-noncompliance, or the investigator feels that it is no longer in the subject's best interest to continue therapy.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s

排除标准

  • Subject has not received fosbretabulin treatment in the study OX4218s

研究组 & 干预措施

Single Arm

Experimental

Subjects will receive fosbretabulin at the same dose and frequency as in study OX4218s

干预措施: fosbretabulin (Drug)

结局指标

主要结局

Change in biomarkers from baseline

时间窗: 48 Weeks

次要结局

未报告次要终点

研究者

发起方
Mateon Therapeutics
申办方类型
Industry
责任方
Sponsor

研究点 (5)

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