NCT00979966

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

Prospective Randomized Phase-II Trial With Temsirolimus Versus Sunitinib in Previously Untreated Patients With Advanced or Metastatic Non-Clear Cell Renal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Central European Society for Anticancer Drug Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-clear Cell Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	Temsirolimus	25 mg intravenously, once weekly infusion
DRUG	Sunitinib	50 mg oral once daily for 4 weeks, followed by 2 weeks rest.

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-07-01
• First posted: 2009-09-18
• Last updated: 2012-07-10

Locations

14 sites across 1 country: Germany