NCT01888042终止2 期
Phase II Study Assessing Everolimus as Fist Line Treatment in Patients With Metastatic Kidney Cancer of Bad Prognosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
It is a an open label, multicentric, phase II study assessing the efficacy of everolimus (given per os) as a first line treatment in kidney cancer of bad prognosis.
92 patients will be included (anticipated). The treatment by everolimus will continue until progression, significant toxicity or withdraw of consent
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 kidney cancer, regardless of histology (except Bellini carcinomas), with measurable or evaluable disease
- •Age >= 18 years
- •With Karnofsky ≥ 60
- •Without prior treatment for metastatic cancer (chemotherapy, targeted therapy, or mTOR inhibitor)
- •Bad prognosis, defined as follows: at least three of the following six criteria of poor prognosis:
- •Karnofsky <80
- •LDH> 1.5 ULN
- •hemoglobin <LLN
- •corrected calcium> 2.5 mmol / l (10 mg / dl)
- •Time frame between initial diagnostic and treatment <1 year
- •More than one metastatic site
- •medullary function: neutrophils ≥ 1.5 x 109 / L, Platelets ≥ 100 x 109 / L, Hb> 8g/dL
- •Hepatic function: bilirubin: ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN in the absence of hepatic metastasis ≤ 5x ULN if hepatic metastasis documented
- •Renal function: creatinine <1.5 x ULN
- •Life expectancy> 3 months,
- •Patient signed informed consent and agreeing to comply with the requirements of the trial
排除标准
- •Previous treatment with chemotherapy, targeted therapy, or mTOR inhibitor
- •Previous radiotherapy in the last 2 weeks
- •Chronic treatment with corticoids or immunosuppressive agents except substitutive opotherapy.. A washout period of at least 8 days must be respected before the patient inclusion.
- •Patients with brain metastases untreated or uncontrolled by prior treatment. The non-progression of the metastases must be proved by comparing two brain scans separated by a minimum interval of 6 weeks.
- •Active bleeding
- •Patient with positive serology HBs (Ag HBs (+) and AC anti-HBc (+)
- •Hypersensitivity to everolimus, sirolimus, to other rapamycin derivatives or to any of the excipients
- •Severe or uncontrolled medical pathology:
- •unstable angina, symptomatic heart failure, myocardial infarction ≤ 6 months before randomization, severe rhythm disorder,
- •Uncontrolled diabetes with glycaemia> 1.5X ULN.
- •Active or uncontrolled infection.
- •cirrhosis or chronic active hepatitis,
- •severe alteration in lung function (> 50% decrease in FEV or vital capacity)
- •Other cancer within the past 3 years, with the exception of basal cell carcinoma and carcinoma in situ of the cervix
- •Pregnant or lactating woman, and adults refusing an effective contraceptive method
- •Participation in another clinical trial with an investigational drug
- •Refusal of the patient to comply with the rules of the clinical trial
- •Person deprived of liberty or person under guardianship, inability to submit to medical treatment test for geographical, social or psychological reasons.
研究组 & 干预措施
Everolimus
Experimental
Everolimus will be administered per os every day at the same hour immediately after a meal with a glass of water 10 mg (1 tablet of 10 mg)
干预措施: Everolimus (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From inclusion to progression, significant toxicity or death wichever come first up to 56 months
次要结局
- Toxicity of Everolimus(From inclusion to progression, significant toxicity or death whichever come first up to 56 months)
- Response rate(From inclusion to progression, significant toxicity or death whichever come first up to 56 months)
- Progression Free Survival (PFS)(From inclusion to progression, significant toxicity or death whichever come first up to 56 months)
研究者
研究点 (1)
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