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临床试验/NCT03837821
NCT03837821进行中(未招募)早期 1 期

A Window-of-opportunity Trial of Abemaciclib Followed by Radical Cystectomy in Patients With Platinum-ineligible Urothelial Carcinoma to Evaluate CDK4/6-dependent Phosphorylation of Pocket Proteins and Clonal Evolution Dynamics

Weill Medical College of Cornell University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
Change in cell-cycle dynamics between pre- and post-Abemaciclib tumor samples

研究概览

简要总结

Single-arm, open-label window-of-opportunity trial of neoadjuvant Abemaciclib in 20 patients, with tumor tissue obtained as standard of care at tumor resection (pre-Abemaciclib) and cystectomy (post-Abemaciclib)

详细描述

A Window-of-Opportunity Trial of Abemaciclib followed by radical cystectomy in patients with Platinum-Ineligible Urothelial Carcinoma to Evaluate CDK4/6-Dependent Phosphorylation of Pocket Proteins and Clonal Evolution Dynamics. Subjects will be treated with Abemaciclib at 200 mg every 12 hours for at least 4 weeks (and likely slightly longer depending upon surgical date). Individual dose reductions will be made on the basis of the AEs observed. In the absence of treatment delays due to adverse event(s), treatment will be continued until the surgical date unless any of the following criteria applies: 1-Disease progression; 2-Intercurrent illness that prevents further administration of treatment; 3-Unacceptable adverse event(s) as a result of Abemaciclib; 4- Patient decides to withdraw from the study; 5-General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator. Patients will be followed with history, physical, and blood tests at each visit to monitor for toxicity. Patients will be followed for survival endpoints following completion of this study for 3 years after surgery or until death. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

All Subjects

Experimental

Abemaciclib 200 mg oral, every 12 hours

干预措施: Abemaciclib (Drug)

结局指标

主要结局

Change in cell-cycle dynamics between pre- and post-Abemaciclib tumor samples

时间窗: At baseline and post 4 week treatment

Cell-cycle dynamics will be assessed by immunohistochemistry of tumor tissues, circulating tumor DNA (ctDNA) blood samples.

次要结局

  • Effect on tumor downstaging defined as <pT2 at time of cystectomy(At baseline and post 4 week treatment)
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) of Abemaciclib(At baseline through 3 year follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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