NCT00529802已完成2 期
An Exploratory Study Evaluating FDG-PET as a Predictive Marker for mTOR Directed Therapy With RAD001 in Metastatic Renal Cell Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Relative Tumor Size Change Following 8 Weeks of Therapy.
研究概览
简要总结
The purpose of this study is to learn if PET scanning can predict the degree of tumor shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.
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
- 否
入选标准
- •Metastatic renal cancer refractory to sorafenib or sunitinib therapy
- •At least one measurable site of disease according to RECIST criteria that has not been previously irradiated.
- •18 years of age or older
- •Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior standard systemic anticancer therapy and adequately recovered from the acute toxicities of any prior therapy.
- •World Health Organization (WHO) performance status <= 2
- •Adequate bone marrow function
- •Adequate liver function
- •Adequate creatinine clearance
- •Signed informed consent
排除标准
- •Prior treatment with any investigational drug within the previous 4 weeks
- •Chronic treatment with systemic steroids or another immunosuppressive agent
- •Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
- •Patients who have a history of another primary malignancy ≤ 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
- •Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- •A known history of HIV seropositivity
- •Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
- •Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
- •Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control from enrollment through 6 months following the end of treatment
- •Patients who have received prior treatment with an mTOR inhibitor.
- •Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
- •History of noncompliance to medical regimens
- •Patients unwilling to or unable to comply with the protocol
研究组 & 干预措施
Everolimus (RAD001) 10mg daily
Experimental
All patients were to receive 10mg everolimus (RAD001) daily.
干预措施: RAD001 (Drug)
结局指标
主要结局
Relative Tumor Size Change Following 8 Weeks of Therapy.
时间窗: 8 weeks
The primary objective is to determine whether high SUV uptake on FDG-PET is associated with greater tumor shrinkage. Tumor size is defined as the sum of unidimensional tumor measurements from standard CT imaging calculated according to RECIST criteria. Tumor size is measured at baseline and after eight weeks of therapy. Tumor shrinkage is the relative change (%) in tumor size from baseline.
次要结局
- Percent Change in FDG-PETUptake Following 2 Weeks of Therapy(2 weeks)
研究者
研究点 (5)
Loading locations...
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