Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma

Exclusion Criteria

• •1. Patients without any venous access for blood sampling.
• •2. Hypersensitivity to the active substance or to any of the excipients.
• •3. History or clinical evidence of central nervous system (CNS) metastases, except for individuals who have previously-treated CNS metastases.
• •4. Corrected QT interval (QTc) \> 480msecs using Bazett's formula.
• •5. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to:
• •* Uncontrolled infection.
• •* Cardiovascular conditions within the last 6 months such as cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New-York Heart Association (NYHA), clinically significant irregular heartbeat requiring medication.
• •* Poorly controlled hypertension \[defined as systolic blood pressure of ≥140 mmHg or diastolic pressure of ≥90 mmHg).
• •* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or deep venous thrombosis (DVT) within the past 6 months.
• •Note: patients with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.
• •6. Evidence of active bleeding or bleeding diathesis.
• •7. Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme cytochrome P450 isoenzyme 3A4 (CYP3A4) within the last 14 days prior to inclusion and/or during the study.
• •8. Patients already treated with an anticancer treatment in the previous four weeks or patient requiring anticancer treatment during the study (chemotherapy, immunotherapy, hormonotherapy, radiotherapy or surgery).
• •9. Pregnant or breast-feeding women.
• •10. Positive diagnostic of HIV, B and C hepatitis.
• •11. Patients with serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent, or compliance to study procedures.
• •12. Patients who has forfeited his/her freedom by administrative or legal award or who is under guardianship.