RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe

Exclusion Criteria

• •1. Patients who had radiation therapy within 28 days prior to start of study.
• •2. Patients who have received prior systemic treatment for their metastatic RCC.
• •3. Patients who received prior therapy with VEGF pathway inhibitor.
• •4. Patients who have previously received systemic mTOR inhibitors.
• •5. Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
• •6. Patients with uncontrolled central nervous system (CNS) metastases.
• •7. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
• •8. Patients with a known history of HIV seropositivity.
• •9. Patients with autoimmune hepatitis.
• •10. Patients with an active, bleeding diathesis.
• •11. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
• •12. Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix.
• •13. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
• •14. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
• •15. Patients unwilling to or unable to comply with the protocol.