A Phase II Study of Axitinib in Patients With Metastatic Renal Cell Cancer Unsuitable for Nephrectomy

Exclusion Criteria

• •1. The presence of intracranial disease, unless stable \>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.
• •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.
• •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:
• •1. inability to take oral medication;
• •2. requirement for intravenous alimentation;
• •3. prior surgical procedures affecting absorption including total gastric resection;
• •4. treatment for active peptic ulcer disease in the past 6 months;
• •5. 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;
• •6. 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