临床试验/NCT01184287

NCT01184287撤回2 期

A Phase II Trial of Addition of Ranpirnase(ONCONASE®) to Permetrexed Plus Carboplatin in Patientes With Non-Squamous Non-Small Cell Lung Cancer

Tamir Biotechnology, Inc.6 个研究点分布在 1 个国家开始时间: 2010年8月18日最近更新: 2015年9月2日

适应症

干预措施

试验速览

阶段: 2 期
状态: 撤回
发起方: Tamir Biotechnology, Inc.
试验地点: 6
主要终点: Response

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

The purpose of the trial is to determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy.

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: 否

入选标准

•Age greater than 18 years
•ECOG less than 2
•Estimated survival of greater than 12 weeks

排除标准

•Prior systemic chemotherapy for locally advanced or metastatic NSCLC
•Use of any investigational agent within 28 days prior to registration
•Known hypersensitivity to any of the study drugs
•Brain metastases or leptomeningeal disease
•History of prior malignancy within the past three years

研究组 & 干预措施

ranpirnase

Experimental

All patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase

干预措施: Ranpirnase (Drug)

结局指标

主要结局

Response

时间窗: 4 or more months

To determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy

次要结局

Progression Free Survival (PFS)(2 years)
Survival(2 years)

研究者

发起方

Tamir Biotechnology, Inc.

申办方类型

Industry

研究点 (6)

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