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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Sirolimus; Sunitinib

Criteria

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.