NCT01078311Unknown不适用
Phase 2 Study of Measurement of Trough Levels of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
South West Sydney Local Health District1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To demonstrate the correlation of trough sorafenib level with overall survival in advanced hepatocellular carcinoma
研究概览
简要总结
Sorafenib improves overall survival and progression free survival in advanced hepatocellular carcinoma. Wide interindividual pharmacokinetic variability was observed. Data from early phase trials in solid tumours showed trough sorafenib levels were associated with incidence of skin rash and hypertension. Rash, hypertension and higher trough levels were moderately predictive of progression free survival.The trough level of sorafenib may be predictive of survival and response in patients treated with sorafenib for advanced hepatocellular carcinoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histologically or cytologically diagnosed hepatocellular carcinoma, or diagnosis on at least one cross-sectional imaging with the characteristic appearance of HCC (i.e. liver lesion with arterial enhancement and portal venous washout)
- •Decision to treat with single agent sorafenib at 400mg bid (dose reductions or interruptions are permitted if side effects occur during treatment)
- •No prior systemic chemotherapy or targeted therapy
- •Child-Pugh liver function class A or B
- •At least one untreated target lesion that can be measured in one dimension according to RECIST
- •Adequate organ functions
排除标准
- •Prior systemic chemotherapy or molecularly targeted therapy
- •Concurrent active malignancy
- •Concomitant strong CYP3A4 induced or inhibitor at a therapeutic dose (see section 6.4.1)
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- •Hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal medical therapy)
- •History of, or known brain metastases (skull metastases allowed), carcinomatous meningitis, or leptomenigeal disease
- •Major surgery (e.g. open abdominal therapy, pelvic, thoracic, orthopaedic or neurosurgery) within 4 weeks of the date of first dose
- •Local-regional treatment (i.e. percutaneous and trans-arterial procedures) within 4 weeks. Restaging CT or MRI scan must be repeated at least 4 weeks after local-regional treatment and within 3 weeks before the date of first dose
- •For patients treated with Yttrium (90Y) radiotherapy, a washout period of 2 months is required.
- •Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol
- •Pregnancy or breast feeding
结局指标
主要结局
To demonstrate the correlation of trough sorafenib level with overall survival in advanced hepatocellular carcinoma
时间窗: 4 years
次要结局
- To correlate trough sorafenib level with progression free survival(4 years)
- To correlate trough sorafenib level with response (disease-control vs progressive disease) by RECIST criteria(4 years)
- To correlate trough sorafenib level with alpha fetoprotein (AFP) response(4 years)
- To correlate trough sorafenib level with side effects (rash and hypertension)(4 years)
研究者
研究点 (1)
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