Study in Non-Clear Cell Renal Carcinoma (Ncc-RCC) Temsirolimus Versus Sunitinib
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|ClinicalTrials.gov Identifier: NCT00979966|
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : July 10, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-clear Cell Renal Cell Cancer||Drug: Temsirolimus Drug: Sunitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Phase-II Trial With Temsirolimus Versus Sunitinib in Previously Untreated Patients With Advanced or Metastatic Non-Clear Cell Renal Carcinoma|
|Study Start Date :||July 2009|
|Primary Completion Date :||July 2012|
25 mg intravenously, once weekly infusion
50 mg oral once daily for 4 weeks, followed by 2 weeks rest.
- Time to progression [ Time Frame: 7-11 months expected ]
- Objective response [ Time Frame: 7-11 months expected ]
- safety assessed using CTCAE v3.0 and safety assessed according to reported SAEs [ Time Frame: 8-12 months (treatment duration + 1 months) ]
- one year progression free survival rate (1YPFSR) [ Time Frame: 1 year ]
- overall survival (OS) [ Time Frame: will be evaluated in 2013 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979966
|Charité - Campus Virchow Klinikum|
|Charité - Mitte|
|Vivantes Klinikum am Urban|
|Evangelische Kliniken Bonn gGmbH - Johanniter-Krankenhaus|
|Klinikum der J.W. Goethe Universität|
|UK-SH Campus Lübeck|
|Klinikum Oldenburg gGmbH|
|Klinikum Stuttgart, Katharinenhospital|
|Facharzt für Innere Medizin,|
|Kliniken Nordoberpfalz AG - Klinikum Weiden|