EUCTR2011-004562-16-GB进行中（未招募）1 期
A Phase II Study of Axitinib in Patients with Metastatic Renal Cell Cancer Unsuitable for Nephrectomy - A-PREDICT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1. Histologically confirmed metastatic renal cell carcinoma of predominant clear cell histology
- •2. Unsuitable for nephrectomy as judged by treating clinician(s)
- •3. Not suitable for ‘watch and wait’ policy as determined by treating clinician(s)
- •4. No prior systemic therapy for renal cell carcinoma
- •5. Measurable metastatic disease using RECIST v1.1 (see Appendix A)
- •6. 18 years of age or older
- •7. Life expectancy of 12 weeks or greater
- •8. ECOG performance status 0 or 1
- •9. Adequate organ function as defined by serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =2.5 x upper limit of normal (ULN), or AST and ALT =5 x ULN if liver function abnormalities are due to liver metastases; total serum bilirubin =1.5 x ULN
- •10. Adequate haematological function as defined by absolute neutrophil count (ANC) =1500/µL, platelets =75,000/µL, haemoglobin =9.0 g/dL and prothrombin time (PT) =1.5 x ULN
- •11. Serum creatinine =1.5 x ULN or calculated creatinine clearance = 60 mL/min;
- •12. Urinary protein <2+ by urine dipstick. If dipstick is =2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2g per 24 hours.
- •13. No evidence of pre-existing uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be =140 mm Hg, and the baseline diastolic blood pressure readings must be =90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
- •14. Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment.
- •15. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including tumour biopsies.
- •16. Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •1. The presence of intracranial disease, unless there has been radiological evidence of stable intracranial disease >6 months. In the case of a solitary brain metastasis which has been resected, there must be evidence of a disease-free interval of at least 3 months post-surgery. All patients previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days.
- •2. The presence of active second malignancy. Patients will be eligible if they have adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, stable prostate cancer or if treated with curative intent for any other cancer with no evidence of disease for 2 years.
- •3. Women who are pregnant or are breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment.
- •4. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy.
- •5. Current signs or symptoms of severe progressive or uncontrolled hepatic, endocrine, pulmonary disease other than directly related to RCC.
- •6. Gastrointestinal abnormalities including:
- •a. inability to take oral medication;
- •b. requirement for intravenous alimentation;
- •c. prior surgical procedures affecting absorption including total gastric resection;
- •d. treatment for active peptic ulcer disease in the past 6 months;
- •e. active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
- •f. malabsorption syndromes.
- •7. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (see section 8.12, concomitant therapy).
- •8. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (see section 8.12, concomitant therapy).
- •9. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access device or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
- •10. Active seizure disorder, spinal cord compression, or carcinomatous meningitis.
- •11. Any of the following within 12 months prior to study entry: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack.
- •12. Deep vein thrombosis or pulmonary embolism within 6 months prior to study entry.
- •13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- •14. Known galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
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