Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib

An Open Label, Single Arm Trial to Evaluate Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of First Line Therapy With Sunitinib or Pazopanib

Patients with metastatic renal cell carcinoma (mRCC) who failed first-line therapy with sunitinib or pazopanib was treated with everolimus. Efficacy and safety of everolimus was evaluated in these patients.

Inclusion Criteria:

• Patients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell renal carcinoma.
• Progression during or after a treatment with sunitinib or pazopanib given in a 1st line treatment situation for mRCC.
• Patients scheduled for treatment with everolimus.
• Patients with at least one measurable lesion at baseline as per RECIST v1.1.

Exclusion Criteria:

• Patients who have received >1 prior systemic treatment for their metastatic RCC. Prior systemic treatment in an adjuvant setting is allowed.
• Patients who have previously received systemic mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).
• Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.
• Patients unwilling or unable to comply with the protocol.