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临床试验/NCT05279690
NCT05279690已完成1 期

Colchicine to Suppress Pro-tumorigenic Inflammation in Patients with Urothelial Cancer and Other Solid Tumors

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年2月14日最近更新:
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
16
试验地点
1
主要终点
Percent Change in Peripheral blood CRP level

研究概览

简要总结

This open-label, non-randomized study aims to determine the anti-inflammatory effect of colchicine on the reduction of peripheral blood CRP in patients with solid tumors or localized urothelial cancer. There are two cohorts, which will enroll separately and parallelly. Cohort 1 will include two successive groups with advanced/recurrent solid tumors (15 patients will receive low-dose colchicine and 15 for high-dose colchicine) who will receive 14 days of colchicine. In Cohort 2, 15 patients with post-radical surgery for high-risk clinically localized urothelial cancer will be enrolled. They will receive one 28-day cycle of colchicine. The primary outcome, post-treatment decline in CRP level, a continuous measure, will be defined as the maximum percentage decline from baseline in post-treatment CRP value within two weeks of colchicine (Cohort 1) or one cycle of colchicine (cohort 2), where the baseline value is measured before any treatment is initiated.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Cohort 1 high-dose colchicine

Experimental

Participants with metastatic solid tumors who will receive high-dose colchicine (0.6 mg oral TID)

干预措施: Colchicine (Drug)

Cohort 1 low-dose colchicine

Experimental

Participants with advanced/recurrent solid tumors who will receive low-dose colchicine (0.6 mg oral BID)

干预措施: Colchicine (Drug)

Cohort 2 Participants with post-radical surgery

Experimental

Participants with post-radical surgery for high-risk clinically localized urothelial cancer will receive colchicine 0.6 mg oral BID.

干预措施: Colchicine (Drug)

结局指标

主要结局

Percent Change in Peripheral blood CRP level

时间窗: Baseline and Within 28 days

The primary outcome, post-treatment decline in peripheral blood CRP level, a continuous measure, will be defined as the maximum percent decline of post-treatment CRP from baseline obtained during the treatment period, where the baseline value is measured before any treatment initiated For a patient with an advanced/recurrent solid tumor who receive 2-weeks of treatment, it will be the maximum percentage decline during the 28 days of treatment. For a patient who receive colchicine less than 28 days, it will be the maximum percentage decline from baseline to the last day of treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deborah Doroshow

Assistant Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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