Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer

Exclusion Criteria

• •1. Patients with a second active malignant tumor.
• •2. Patients with tumors treated in the last 2 years.
• •3. Pregnant or breastfeeding women.
• •4. Women of child-bearing potential who do not agree to use a contraceptive method during treatment. Women participating in the study should have undergone surgical sterilization, be post-menopausal, or agree to use a highly effective contraceptive method (in accordance with CTFG (clinical trial facilitation group) criteria) during the treatment period. Patients of both sexes and their partners must use effective contraception during treatment and, at least, up to four months after completing treatment. Since oral contraceptives cannot possibly be considered "effective contraceptive methods", they should be used in conjunction with another method, such as a barrier method
• •5. Fertile men who do not agree to use a contraceptive method during treatment. Male participants in the study should have undergone surgical sterilization, or agree to use a highly effective contraceptive method (in accordance with CTFG (clinical trial facilitation group) criteria) during the treatment period.
• •6. Patients with gastrointestinal disorders, including:
• •* Inability to take oral medication.
• •* Need for parenteral nutrition.
• •* Prior surgical procedures affecting absorption.
• •* Active gastrointestinal bleeding.
• •* Malabsorption syndrome.
• •* Gastrointestinal disorders that increase the risk of perforation.
• •7. Patients who have had any of the following conditions within the 12 months prior to inclusion in the study: myocardial infarction, uncontrolled angina, uncontrolled hypertension, peripheral arterial or coronary graft bypass, congestive heart failure, stroke, or transient ischemic attack.
• •8. Patients with tumors that invade or affect major blood vessels, gastrointestinal tract, or trachea/bronchi.
• •9. Patients with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases.
• •10. Patients with active hepatitis or hepatitis C.
• •11. Patients with active tuberculosis.
• •12. Patients with uncontrolled (Ca \> 12 mg/dL) or symptomatic hypercalcemia who require continuous treatment with bisphosphonates or denosumab.
• •13. Patients who have undergone major surgery within 4 weeks prior to inclusion in the study.
• •14. Patients with active bleeding.
• •15. Patients with a recent episode of intestinal obstruction.
• •16. Patients who have previously received VEGF (vascular endothelial growth factor)-targeted therapy for advanced disease.
• •17. Patients who have undergone radiation therapy for bone metastases within 2 weeks prior to the first dose of cabozantinib, or any external radiation therapy within 4 weeks prior to the first dose of cabozantinib.
• •18. Patients who have received an allogeneic transplant or stem cells in the last 5 years.
• •19. Malignant tumors within 3 years before Day 1 of Cycle 1, except for those with negligible risk of metastasis or death and who have been treated with curative intent, such as cervical carcinoma in situ or localized prostate cancer treated with curative intent.
• •20. Patients receiving therapeutic doses of oral anticoagulants (e.g., warfarin, direct thrombin inhibitors and Factor Xa) or antiplatelet agents (e.g., clopidogrel). The use of low molecular weight heparins is allowed
• •21. Hypersensitivity to the active substance or to any of the excipients (exclude lactose intolerant patients since each film-coated tablet contains 46.61 mg of lactose).
• •22. Any other clinical condition that the physician responsible for the patient considers to be inappropriate for inclusion in the study.