NCT01414296已完成1 期
Extended 39-Week Study of PSMA ADC Following the Initial 12-Week Dose-escalation Study in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of subjects with Adverse Events
研究概览
简要总结
Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301EXT is an open-label, nonrandomized, phase 1 extension study of PSMA ADC administered IV in subjects with progressive CMPC that has progressed after prior taxane therapy. Subjects who have participated in PSMA ADC 1301 and who, in the opinion of the PI, are likely to benefit from continued treatment with PSMA ADC will be enrolled in PSMA ADC 1301EXT.
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
- •Subjects who have completed the PSMA ADC 1301 study and who, in the opinion of the investigator, have derived benefit from treatment with PSMA ADC.
- •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
- •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
Number of subjects with Adverse Events
时间窗: 39 weeks
Safety and tolerability of PSMA ADC as measured by all adverse events, hematology, blood chemistry, and urine values, vital signs, electrocardiogram, and physical exam.
次要结局
未报告次要终点
研究者
研究点 (1)
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