ISRCTN38957238已完成2 期
A study of PaZopanib efficacy and safety in patients with advanced clear-cell renal cell carcinoma and ECOG Performance Status 2 (PaZ02): A non-randomised phase II trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
研究概览
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Written informed consent
- •2. Histologically confirmed diagnosis of renal cell carcinoma with clear cell component
- •3. Locally advanced (defined as not amenable of curative surgery) or metastatic disease
- •4. Measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST) Criteria 1.1
- •5. Performance Status 2 assessed using the ECOG scale
- •6. No prior systemic therapy
- •7. Female patients of childbearing potential will be eligible if they agree to adequate contraception. Pregnancy test must be negative 1 week before first drug dose
- •8. Adequate organ function as defined by the following criteria:
- •8.1. Total serum bilirubin =1.5 x upper limit normal (ULN). Patients with Gilbert?s disease are eligible if the total bilirubin is <3.0 x ULN and direct bilirubin is = 35%.
- •8.2. Serum transaminases (AST and ALT) <2.5 x ULN, unless liver metastases are documented in which case AST and ALT must be = 5 x ULN
- •8.3. Calculated creatinine clearance = 30mL/min (Cockroft Gault method)
- •8.4. Urine Protein to Creatinine Ratio (UPC) < 1. If UPC = 1 then a 24 hour urine protein must be assessed. Only patients with 24 hour urine protein < 1g will be eligible
- •8.5. Total serum calcium concentration < 2.9 mmol/l
- •8.6. Absolute neutrophil count (ANC) = 1500/mm3
- •8.7. Haemoglobin = 9g/dl
- •8.9. Platelets = 100,000/mm3
- •8.10. INR (International Normalised ratio) = 1.2 x ULN. Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range
- •9. Age =18
- •10. Life expectancy = 12 weeks
- •11. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
排除标准
- •1. Pregnant or lactating female patients. Patients who agree to discontinue nursing 14 days prior to commencing treatment and do not nurse throughout all the treatment period are eligible
- •2. Previous systemic treatment for renal cell carcinoma (RCC) (licensed or investigational) including adjuvant or neoadjuvant therapy
- •3. Major surgery or trauma < 4 weeks or radiotherapy and/or presence of any nonhealing wound, fracture, or ulcer. Radiotherapy < 2 weeks prior to starting treatment
- •4. History or clinical evidence of brain metastases or active seizure disorders
- •5. Previous malignancies within the last 5 years, with the exception of successfully treated superficial or in situ carcinomas and of invasive tumours treated with curative intent and in remission for at least 5 years
- •6. Current use of drugs which are known strong CYP4A inhibitors (7.10)
- •7. Use of any prohibited medications within 14 days of the first dose of study medication (
- •8. Uncontrolled hypertension defined as systolic blood pressure = 150 mm Hg or diastolic blood pressure = 95 mm Hg. Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry
- •9. Presence of uncontrolled infection
- •10. Prolongation of the QT interval (QTc) > 480 msecs
- •11. History of malabsorption, major gastrointestinal tract resection or other pathology likely to affect study drug absorption
- •12. History of any one or more of the following cardiovascular conditions within the past 6 months:
- •12.1. Cardiac angioplasty or stenting
- •12.2. Myocardial infarction
- •12.3. Unstable angina
- •12.4. Coronary artery bypass graft surgery
- •12.5. Symptomatic peripheral vascular disease
- •12.6. Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) Functional Classification
- •13. History of cerebrovascular accident (CVA) including transient ischemic attack (TIA) within the past 12 months
- •14. History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Patients with recent DVT who have been treated with therapeutic anticoagulating agents for at least 6 weeks are eligible
- •15. Evidence of active bleeding or bleeding diathesis
- •16. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- •17. Any serious and/or unstable preexisting medical, psychiatric, or other conditions that could interfere with subject?s safety, obtaining informed consent or compliance to the study
- •18. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drug chemically related to pazopanib
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