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Spots Global Cancer Trial Database for A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.

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Trial Identification

Brief Title: A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.

Official Title: A Phase II, Randomized, Open-label, Multicenter, Study Evaluating the Efficacy of Sorafenib Alone and Sorafenib in Combination With Low Dose Interferon Alpha-2a as Second-line Treatment of Sunitinib Failure in Patients With Metastatic Renal Cell Carcinoma

Study ID: NCT00678288

Study Description

Brief Summary: This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, Salzburg, , Austria

, Wien, , Austria

, Avignon, , France

, Bayonne, , France

, Bordeaux, , France

, Marseille, , France

, Marseille, , France

, Nantes, , France

, Paris, , France

, Paris, , France

, Reims, , France

, Strasbourg, , France

, Toulouse, , France

, Vandoeuvre Les Nancy, , France

, Cork, , Ireland

, Dublin, , Ireland

, Aviano, Pordenone, Italy

, Legnago, Verona, Italy

, Napoli, , Italy

, Pavia, , Italy

, Perugia, , Italy

, Reggio Emilia, , Italy

, Gdansk, , Poland

, Lublin, , Poland

, Warszawa, , Poland

, Wroclaw, , Poland

, Barcelona, , Spain

, Madrid, , Spain

, Madrid, , Spain

, Oviedo, , Spain

, Pamplona, , Spain

, Valencia, , Spain

, Northwood, Middlesex, United Kingdom

, Newcastle Upon Tyne, Tyne and Wear, United Kingdom

, London, , United Kingdom

Contact Details

Name: Bayer Study Director

Affiliation: Bayer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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