NCT01240577已完成1 期
An Early Phase I Study of IPdR Absorption, Metabolism, and Safety in Patients With Advanced Solid Tumors and Lymphomas
适应症
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
- 2
- 主要终点
- -Measure plasma concentrations of IPdR, IdUrd, and IdUrd metabolites after a single oral dose of IPdR.-Determine the safety of administering a single oral dose of IPdR.
研究概览
简要总结
Background:
- The experimental drug IPdR is broken down in the body to IdUrd, which has been given to patients to find out if it can improve radiation therapy. IdUrd has to be given through a vein; therefore this new drug (IPdR) has been made which can be taken by mouth. Researchers are interested in determining whether IPdR should also be studied to find out if it can improve radiation therapy. The current study is to find out if people absorb the drug given by mouth.
Objectives:
- To evaluate the levels of drug and its breakdown products in the blood following a single dose of IPdR by mouth. .
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with cancer (solid tumors or lymphomas) that have not responded to standard treatment.
Design:
- This study involves an initial dosing visit, one day of admission to the hospital for blood work, and a follow-up visit 14 days later.
- Participants will be screened with a physical examination and medical history, as well as blood and urine samples.
- Participants will receive a single dose of IPdR, and will provide multiple blood and urine samples for 24 hours after administration of the drug.
- Fourteen days after receiving IPdR, participants will have another physical examination and additional blood and urine tests to evaluate how IPdR has been broken down by the body.
- Cancer treatment will not be provided as part of this protocol.
详细描述
Background:
- The nucleoside analog iododeoxyuridine (IdUrd, NSC 39661) has shown promising activity as a radiosensitizer in preclinical models and has been evaluated in Phase I/II clinical trials. The extent of radiosensitization is directly related to the incorporation of IdUrd into tumor DNA as a replacement for thymidine.
- IPdR (NSC 726188) is an orally administered prodrug of IdUrd with a better therapeutic index in preclinical models.
- This first in human study of IPdR will evaluate whether IPdR is absorbed and what plasma levels of IPdR and its major metabolite, IdUrd, are achieved after a single oral dose.
Objectives:
- Measure plasma concentrations of IPdR, IdUrd, and IdUrd metabolites after a single oral dose of IPdR
- Determine the safety of administering a single oral dose of IPdR.
Eligibility:
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 110 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
-Measure plasma concentrations of IPdR, IdUrd, and IdUrd metabolites after a single oral dose of IPdR.-Determine the safety of administering a single oral dose of IPdR.
次要结局
未报告次要终点
研究者
研究点 (2)
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