NCT00651482终止2 期
Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus)
Sandy Srinivas1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2008年8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
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
To determine the safety and efficacy of the combination of bevacizumab and everolimus (RAD001) for the treatment of metastatic renal cell 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
- •Signed Informed Consent Form
- •Histologically confirmed metastatic RCC that is predominantly clear cell Measurable disease, as defined by RECIST
- •Age ≥ 18 years
- •ECOG performance status of 0 or 1
- •No more than 1 prior targeted therapy (eg, sorafenib, sunitinib) (prior cytokine therapy allowed)
- •No more than 2 prior systemic therapies
- •Ability and capacity to comply with the study and follow-up procedures
- •General Exclusion Criteria
- •Inability to comply with study and/or follow-up procedures
- •Life expectancy of < 12 weeks
- •Inadequate organ function, as evidenced by any of the following at screening:
- •Absolute neutrophil count (ANC) < 1500/uL
- •Platelet count ≤ 100 x 10^9/L
- •Total bilirubin ≥ 1.5 x upper limit of normal (ULN)
- •AST and/or ALT > 2.5 x ULN for patients without evidence of liver metastases, or 5 x ULN for patients with documented liver metastases
- •Serum creatinine > 2.0 mg/dL
- •Hemoglobin < 9 g/dL (may be transfused or receive epoetin alfa to maintain or exceed this level)
- •Active infection or fever > 38.5°C within 3 days of starting treatment
- •Women who are pregnant or breast feeding,
- •Able to conceive and unwilling to practice an effective method of birth control.
- •History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer
- •Malignancies that have undergone a putative surgical cure (i.e., localized prostate cancer post-prostatectomy) within 5 years prior to Day 1 may be discussed with the Principal Investigator.
- •Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results.
- •Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
- •Disease-Specific Exclusion Criteria
- •RCC with predominantly sarcomatoid features
- •Radiotherapy for RCC within 28 days prior to Day 1, with the exception of single-fraction radiotherapy given for the indication of pain control
- •Prior treatment with bevacizumab or any mTOR inhibitor (eg, temsirolimus, sirolimus, or everolimus)
- •Current need for dialysis
- •Bevacizumab-Specific Exclusions
- •Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
- •Any prior history of hypertensive crisis or hypertensive encephalopathy
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- •History of stroke or transient ischemic attack within 6 months prior to study enrollment
- •Known CNS disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
- •Significant vascular disease (eg, aortic aneurysm, aortic dissection)
- •Symptomatic peripheral vascular disease
- •Evidence of bleeding diathesis or coagulopathy that is not intentionally pharmacologically-induced
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- •Serious, non-healing wound, ulcer, or bone fracture
- •Proteinuria at screening as demonstrated by a urine protein:
- •Creatinine (UPC) ratio ≥ 1.
- •If UPC ratio ≥ 1.0, the patient must undergo a 24 hour urine collection which must demonstrate ≤ 1g of protein in 24 hours to be eligible.
- •Known hypersensitivity to any component of bevacizumab
- •RAD001-Specific Exclusion Criteria
- •Known hypersensitivity to any component of RAD001
- •Chronic treatment with systemic steroids or another immunosuppressive agent
- 另有 8 项未显示
排除标准
- 未提供
研究组 & 干预措施
Bevacizumab + RAD001 (everolimus)
Experimental
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
干预措施: Everolimus (Drug)
Bevacizumab + RAD001 (everolimus)
Experimental
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: 24 months
Progression-free survival (PFS) per RECIST criteria
次要结局
- Objective Response (OR) Duration(24 months)
- Objective Response (OR)(24 months)
- Time-to-Treatment Failure (TTF)(24 months)
- Overall Survival (OS)(44 months)
- Number of Subjects With Drug-related SAEs(24 months)
- Total Number of Drug-related SAEs(24 months)
- Treatment Discontinuation Due to Toxicity(24 months)
- Treatment Discontinuation Due to Disease Progression(24 months)
研究者
Sandy Srinivas
Associate Professor
Stanford University
研究点 (1)
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