NCT03137758终止1 期
A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Toxicities and Adverse Events
研究概览
简要总结
This is an open label, non-randomized, Phase I, dose escalation/dose expansion study of PCUR-101 in combination with androgen suppression therapy in the patients with metastatic CRPC
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •histologically confirmed diagnosis of metastatic CRPC
- •standard of care androgen deprivation treatment
- •castrate serum level of testosterone of ≤ 50 ng/dL (≤ 1.73 mmol/L)
- •progressive disease while receiving androgen deprivation therapy
- •previously treated with abiraterone, enzalutamide alone or in combination AND must have demonstrated evidence of objective progression as per PCWG3 criteria
- •adequate hematologic, renal and hepatic function
- •KPS of ≥ 70 or ECOG of 0 to 1
排除标准
- •pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology
- •use of opiate analgesics for prostate cancer pain within 4 week of treatment start
- •more than one sequential second generation AR-directed therapy
- •received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks or other investigational agents within 4 weeks
- •history of bleeding disorder
- •history of seizure disorder
- •concomitant use of therapeutic anticoagulation
- •history of or current cardiac issues
- •received external beam radiation therapy within 4 weeks
- •CTCAE Grade > 2 neuropathy
研究组 & 干预措施
Level 1 (50 mg) PCUR-101
Experimental
Starting Dose, 3+3 Cohort Design
干预措施: PCUR - 101 (Drug)
Level 2 (100 mg) PCUR-101
Experimental
干预措施: PCUR - 101 (Drug)
Level 3 (150 mg) PCUR-101
Experimental
干预措施: PCUR - 101 (Drug)
Level 4 (200 mg) PCUR-101
Experimental
干预措施: PCUR - 101 (Drug)
Level 5 (250 mg) PCUR-101
Experimental
干预措施: PCUR - 101 (Drug)
Level 6 (300 mg) PCUR-101
Experimental
干预措施: PCUR - 101 (Drug)
结局指标
主要结局
Toxicities and Adverse Events
时间窗: 28 days
determined by type and severity using the most recent version of the CTCAE criteria
次要结局
- Toxicities and adverse events(up to 2 years)
- Response(up to 2 years)
研究者
研究点 (3)
Loading locations...
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