drugset / Trial / NCT00979966

Study in Non-Clear Cell Renal Carcinoma (Ncc-RCC) Temsirolimus Versus Sunitinib

NCT00979966

RandomizedParallel-groupOpen-labelTreatment

Summary

This will be a prospective, open-label, randomized multicenter phase-II study to evaluate progression free survival (PFS) in patients with locally advanced or metastatic non-clear cell renal cell cancer (ncc-RCC) receiving Temsirolimus in comparison to Sunitinib. In most clinical trials in renal cell carcinoma (RCC), clear cell RCC have been included exclusively. There are only some limited data on the efficacy of Temsirolimus or Sunitinib in ncc-RCC showing interesting response rates for both agents. However, randomized clinical trials in this specific patient population have not yet been performed. In the proposed study a comparison Temsirolimus and Sunitinib is scheduled in first line therapy of ncc-RCC.

Timeline

Start
2009-07
Primary completion
2012-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Sunitinib Small molecule 50 mg Oral
Subject Temsirolimus Small molecule 25 mg Intravenous

Indications