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

Inclusion criteria

• ≥ 18 years old.
• Patients with metastatic papillary renal cell carcinoma, type I or II.
• Patients with at least one measurable lesion.
• Patients with an ECOG Performance Status ≤1.
• Adequate bone marrow function.
• Adequate liver function.
• Adequate renal function.
• Adequate lipid profile.

Exclusion criteria

• Patients who had radiation therapy within 28 days prior to start of study.
• Patients who have received prior systemic treatment for their metastatic RCC.
• Patients who received prior therapy with VEGF pathway inhibitor.
• Patients who have previously received systemic mTOR inhibitors.
• Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
• Patients with uncontrolled central nervous system (CNS) metastases.
• Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
• Patients with a known history of HIV seropositivity.
• Patients with autoimmune hepatitis.
• Patients with an active, bleeding diathesis.
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
• 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.
• Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
• Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
• Patients unwilling to or unable to comply with the protocol.