NCT00854620已完成2 期
A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University
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
- 9
- 试验地点
- 1
- 主要终点
- Time-to-progression (TTP)
研究概览
简要总结
Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib
详细描述
Sorafenib to be administered as 28-day cycles.
Sorafenib dose escalation by cycle is:
- Cycle 1: 400 mg BID
- Cycle 2: 600 mg BID
- Cycle 3+: 800 mg BID
Within subject dose escalation and maximum dose is dependent on observed tolerability.
Dose escalation only occurs after acceptable tolerability is demonstrated by subject.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically- or cytologically-confirmed metastatic or unresectable renal cell carcinoma (RCC).
- •must have a component of conventional clear cell renal carcinoma.
- •No more than one prior systemic therapy.
- •No prior vascular endothelial growth factor receptor agents.
- •Prior palliative radiotherapy in metastatic lesion(s) is permitted, provided the subject has at least one measurable and/or evaluable lesion(s) that has not been irradiated.
- •All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to Day 1 dosing. Patients must have recovered from surgery and/or radiotherapy toxicity prior to Day 1 dosing.
- •Measureable disease by RECIST criteria
- •Karnofsky performance status at least 70% or ECOG not more than 2
- •Ability to give written informed consent
- •At least 18 years old
- •Negative pregnancy test within 7 days of Day 1 dosing (female subjects of childbearing potential)
- •Sexually active fertile subjects must agree to use an accepted method of contraception during the course of the study for 3 months thereafter.
- •ANC at least 1,500/uL
- •Platelet count at least 100,000/uL
- •AST/ALT not more than 2.5 times the upper limit of normal (ULN)
- •Alkaline phosphatase not more than 2.5 x ULN
- •Serum bilirubin not more than 1.5 x ULN
- •Amylase/Lipase within normal range
- •Urinalysis not more than 1+ protein
- •Serum creatinine not more than 1.5 x ULN
- •No active ischemia by ECG
- •Echocardiogram or MUGA ejection fraction at least 40%
排除标准
- •Ongoing hemoptysis
- •Cerebrovascular accident within 12 months
- •Peripheral vascular disease with claudication on less than 1 block
- •History of clinically significant bleeding
- •Malignancy with true papillary/sarcomatoid features without any clear cell component
- •Chromophobe
- •Collecting duct tumors
- •Transitional cell carcinoma
- •Deep venous thrombosis or pulmonary embolus within one year of consent
- •Ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed
- •Subjects with evidence of current central nervous system (CNS) metastases
- •MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to Day 1 dosing
- •Significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV)
- •Angina pectoris requiring nitrate therapy
- •Myocardial infarction within the last 6 months
- •Uncontrolled hypertension (defined as blood pressure at least 160 mmHg systolic or at least 90 mmHg diastolic on medication)
- •Ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency). Topical and/or inhaled steroids are allowed.
- •Uncontrolled psychiatric disorder
- •Delayed healing of wounds, ulcers, and/or bone fractures
- •Prior malignancy (EXCEPTIONS: adequately-treated basal cell or squamous cell skin cancer or any other cancer for which chemotherapy has been completed > 5 years ago and from which the patient has been disease-free for > 5 years)
- •Currently lactating
- •Currently using St John's Wort (an herb)
研究组 & 干预措施
Sorafenib
Experimental
- Cycle 1: 400 mg BID sorafenib
- Cycle 2: 600 mg BID sorafenib
- Cycle 3+: 800 mg BID sorafenib
干预措施: Sorafenib (Drug)
结局指标
主要结局
Time-to-progression (TTP)
时间窗: 12 months
次要结局
未报告次要终点
研究者
Sandy Srinivas
Associate Professor of Medicine
Stanford University
研究点 (1)
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