临床试验/NCT01414283

NCT01414283已完成1 期

A Phase 1 Dose-escalation Study of PSMA ADC in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer

Progenics Pharmaceuticals, Inc.1 个研究点分布在 1 个国家目标入组 52 人开始时间: 2008年10月最近更新: 2013年11月1日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Progenics Pharmaceuticals, Inc.
入组人数: 52
试验地点: 1
主要终点: Determine the maximum tolerated dose of PSMA ADC

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

Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301 is an open-label, dose-escalation phase 1 study of PSMA ADC administered IV in subjects with progressive, castration-resistant, metastatic prostate cancer that has progressed after prior taxane therapy. For all subjects, PSMA ADC will be administered in four repeating cycles.

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: Male
接受健康志愿者: 否

入选标准

•A diagnosis of progressive, castration-resistant, metastatic prostate cancer.
•Prior chemotherapy regimens, one of which contains taxane.
•Eastern Cooperative Oncology Group status of 0 or 1

排除标准

•Clinically significant cardiac disease or severe debilitation pulmonary disease
•Evidence of an active infection requiring ongoing antibiotic therapy
•Any prior treatment with any other therapy targeting PSMA
•History of drug and/or alcohol abuse

研究组 & 干预措施

Arm 1

Experimental

干预措施: PSMA ADC (Drug)

结局指标

主要结局

Determine the maximum tolerated dose of PSMA ADC

时间窗: 13 weeks

次要结局

未报告次要终点

研究者

发起方

Progenics Pharmaceuticals, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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