NCT02093598已完成2 期
"A Phase IIa Pharmacokinetic-pharmacodynamic Study to Confirm the Inhibitory Effect of Temsirolimus, Targeting the mTOR Pathway in Endometrial Carcinoma"
MedSIR0 个研究点目标入组 10 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- To evaluate the mTOR inhibitor effects of temsirolimus directly on endometrial tumor tissue after four weeks of therapy.
研究概览
简要总结
Type of Application: Clinical trial of new indication.
Experimental drug: The study dose of temsirolimus will be 25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses). Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin). Pharmacotherapeutic group: Protein Kinase Inhibitors; ATC code: L01X E09.
Primary Objective:
- To identify in tumor samples future biomarkers associated with a short term exposure to temsirolimus.
- This is an exploratory clinical study. No efficacy objectives are included in this clinical trial.
Secondary Objectives:
- To estimate the tolerability for all temsirolimus-treated patients throughout the study and up to 28 days after the last dose of temsirolimus.
- To correlate observed changes with the different type of endometrial carcinoma (type I and type II), with regard to proteins related to mTOR (p4EBP1, pS6K1, c-MYC, cyclin D, p27, BAD, p53, Bcl-2 PTEN, pAKT, mTOR),
- To estimate the potential predictive value of some biomarkers (immunostaining for PTEN, pAKT, mTOR), relevant mutations in PTEN, PI3KCA, k-RAS, CTNNB1, and microsatellite instability status.
- To estimate the prognostic value of Ki67 expression after short-term presurgical therapy exposure
- To collect data about the differences in expression profile, assessed by RNA microarrays
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Patients must have histologically-confirmed endometrial cancer
- •Stage I - II (grade 1, 2 or 3), candidates for surgery as the primary treatment
- •Age ≥ 18 years
- •WHO performance status ≤ 2
- •Adequate bone marrow function
- •Adequate liver function
- •Adequate renal function
- •Fasting serum cholesterol ≤300 mg/dL or ≤7.75 mmol/L and fasting triglycerides ≤ 2.5 x ULN
- •Signed informed consent
排除标准
- •Subjects who have received prior anticancer therapies for the current endometrial cancer
- •Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study
- •Prior treatment with any investigational drug within the preceding 4 weeks
- •Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent
- •Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
- •Uncontrolled brain or leptomeningeal metastases
- •Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
- •Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- •Patients with an active, bleeding diathesis
- •Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods
- •Patients who have received prior treatment with an mTOR inhibitor
- •Patients with a known hypersensitivity to rapamycine derivates or to its excipients
- •History of noncompliance to medical regimens
- •Patients unwilling to or unable to comply with the study protocol
研究组 & 干预措施
Temsirolimus
Experimental
25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses).
干预措施: Temsirolimus (Drug)
结局指标
主要结局
To evaluate the mTOR inhibitor effects of temsirolimus directly on endometrial tumor tissue after four weeks of therapy.
时间窗: 1 month after last dose of the last patient
To evaluate the mTOR inhibitor effects, assessed by level 4EBP1 and S6K1, of temsirolimus directly on endometrial tumor tissue after four weeks of therapy.
次要结局
- To evaluate if mTOR inhibition is associated with changes in tumor-tissue(1 month after the surgery of the last patient)
研究者
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