EUCTR2012-001337-13-ES进行中（未招募）1 期
A randomized phase II study to explore the efficacy and feasibility of upfront rotations between sunitinib and everolimus versus sequential treatment of first line sunitinib and second line everolimus until progression in patients with metastatic clear cell renal cancer. - SUNRISES
APRO0 个研究点目标入组 115 人开始时间: 2012年5月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 115
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Renal cell carcinoma with a predominant clear cell component confirmed by histology or cytology
- •-Advanced disease: metastatic AND, not suitable for resection
- •-Male or female, aged 18 years or older
- •-ECOG 0 or 1
- •-Low or intermediate MSKCC prognostic risk score
- •-Target and/or non-target lesions according to RECIST 1.1
- •-Expected survival of at least 3 months.
- •-No prior systemic treatment.
- •-Adequate bone marrow function
- •-Adequate liver function
- •-Adequate renal function as shown by serum creatinine < 1.5 x ULN
- •-Left ventricular ejection fraction >55% on gated cardiac blood pool scan, or normal left ventricular function and fractional shortening on echocardiogram (according to institutional limits).
- •-Systolic blood pressure <140mmHg and diastolic blood pressure <90mmHg (it is acceptable to initiate antihypertensive treatment prior to registration to achieve these goals).
- •-Able to commence treatment within 7 days of registration.
- •-Willing and able to comply with follow-up and all other protocol requirements.
- •-Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •-Prior treatment with VEGF-targeting agents or multi-kinase inhibitors or mTOR-targeting agents
- •-Active central nervous system metastases.
- •-Other malignancy diagnosed within the last 5 years, except the following if adequately treated: superficial squamous cell carcinoma or basal cell carcinoma of skin, superficial bladder cancer (T1 and G1 or T1 and G2), stage 1 cervical cancer.
- •-Treatment with an investigational agent in the last 4 weeks.
- •-Known to be HIV positive
- •-Evidence of chronic hepatitis due to HBV or HCV
- •-Clinically significant heart disease
- •-History of hypertension requiring hospitalization.
- •-Other serious illnesses, e.g. active infection requiring antibiotics, bleeding disorders.
- •-Immunotherapy or chemotherapy in the last 4 weeks
- •-Major surgery in the last 4 weeks, or planned in the next 6 weeks.
- •-Radiation therapy in the last 2 weeks, or planned in the next 6 weeks
- •-grade 3 or worse hemorrhage in last 4 weeks
- •-Any of the following in the last year: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
- •-Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- •-Ongoing cardiac dysrhythmias grade >2, atrial fibrillation of any grade, or prolongation of the corrected QT interval (QTc) to >450 msec for males or >470 msec for females
- •-Uncontrolled diabetes as defined by fasting serum glucose >1.5 X ULN
- •-Pregnancy
- •-Known allergy or hypersensitivity to everolimus, sunitinib or iodine
- •-Medical or psychiatric condition that compromises the patients ability to give informed consent
研究者
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