Metabolizing Enzyme Genotype Versus Exemestane Metabolism Profiles
2018年5月23日 更新者:Milton S. Hershey Medical Center
It is the investigators hypothesis that exemestane (EXE) metabolism is an important source of the inter-individual variation in EXE metabolic profiles and that polymorphisms in EXE-metabolizing enzymes may potentially play a role in affecting EXE therapeutic efficacy and toxicity.
The goals of this clinical study are to (1) establish EXE metabolism profile kinetics, and (2) determine whether correlations exist in vivo between metabolizing enzyme genotype and urinary EXE metabolite profiles in women being treated with EXE.
Together, these studies will allow us to fully characterize functionally-relevant polymorphisms in the EXE-metabolizing enzyme pathway that are potentially important in EXE clinical efficacy.
研究概览
地位
完全的
条件
详细说明
Aromatase inhibitors (AIs) are widely used as adjuvant treatment for estrogen-receptor positive breast cancer in post-menopausal women.
AIs have been demonstrated to have equal to or greater efficacy and less toxicity than tamoxifen (TAM), the drug of choice for many years.
Exemestane (EXE) is a 3rd-generation AI that has demonstrated efficacy in the treatment of breast cancer patients, and as with TAM and other AIs, there has been considerable inter-individual variability in overall response to EXE and in the occurrence of toxicities, but the causes of this variability have not been elucidated.
Differences in drug metabolism can be a source of variability between patients.
Genetic variations occur in several of the enzymes involved in phase I and II metabolic reactions and many of these can lead to alterations in enzyme activity which in turn can alter therapeutic response to drugs.
EXE is extensively metabolized as unchanged EXE and is found at less than 1% in urine and 10% in plasma.
EXE pharmacokinetics will be established in a series of 20 subjects taking EXE.
EXE metabolites will then be measured at an optimal time post-EXE dose in the urine of 200 breast cancer patients being treated with EXE to establish whether metabolizing enzyme genotype-EXE metabolism phenotype correlations exist in vivo.
研究类型
观察性的
注册 (实际的)
170
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Pennsylvania
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Hershey、Pennsylvania、美国、17033
- Penn State Milton S. Hershey Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Post-menopausal breast cancer patients in the breast oncology clinic at the Penn State Hershey Cancer Institute (PSHCI).
描述
Inclusion Criteria:
- Breast cancer patients who have ER+ tumors and are taking 25 mg EXE daily (orally)
- Post-menopausal women or chemically post-menopausal women (who won't become pregnant since they are taking zoladex), or women who are post-menopausal as a result of ovary removal
- Patients may be at any point in their hormonal treatment, but must have completed any planned surgery, radiation and chemotherapy.
Exclusion Criteria:
- Concurrent use of corticosteroids, megestrol, or phenobarbitol (inhaled and internasal steroids are permitted)
- History of allergy to exemestane
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Breast cancer, exemestane treatment
Breast cancer patients receiving standard of care exemestane
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Metabolizing enzyme genotype vs EXE metabolism profiles
大体时间:6 years
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Functional genotypes will be determined for EXE-metabolizing enzymes and will be correlated with blood/urinary EXE metabolism profiles
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6 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
EXE toxicities
大体时间:6 years
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Patient-reported EXE-induced toxicities will be measured.
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6 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Philip Lazarus, Ph.D.、Penn State College of Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年9月1日
初级完成 (实际的)
2017年4月18日
研究完成 (实际的)
2018年5月1日
研究注册日期
首次提交
2012年6月20日
首先提交符合 QC 标准的
2012年6月21日
首次发布 (估计)
2012年6月22日
研究记录更新
最后更新发布 (实际的)
2018年5月25日
上次提交的符合 QC 标准的更新
2018年5月23日
最后验证
2018年5月1日
更多信息
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