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Advanced Renal Cell Carcinoma Therapy Study

Clinical Trial Title: 
Study to evaluate the safety and efficacy of study drug plus everolimus in patients with advanced renal cell carcinoma.
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Nicklas Pfanzelter, MD
Clinical Trial Protocol Description: 

To provide study drug plus everolimus or everolimus to patients with advanced renal cell carcinoma and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have received at least one course of therapy with a VEGFR-targeting tyrosine kinase inhibitor (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib) and progressed within 6 months of planned first dose of study treatment.
  • Have tissue blocks or tissue sections from initial diagnosis or upon diagnosis of advanced metastatic disease will be available for submission to the central laboratory within approximately 4 weeks after initiation of study treatment. 
  • Have an ECOG performance status of 0, 1 or 2.

You will be excluded from the study if any of the following criteria apply to you:

  • Have had prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (e.g., temsirolimus).
  • Have had myocardial infarction within the previous 6 months before planned first dose of study drug.
  • Have chronic treatment with corticosteroids or other immunosuppressive agents.
  • Have had radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before planned first dose of study drug. Systemic treatment with radionuclides within 6 weeks before planned first dose of study drug. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Kidney and Urinary System Disorders
Contact Phone: 
(312) 942-5526
Contact Name: 
Pamela Sroka, BSN, RN, CCRC