stop_circleTerminated/Withdrawn
Carcinoma, Renal Cell
Bayer Identifier:
12782
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
16Trial Dates
April 2008 - June 2009Phase
Phase 2Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hôpital Saint André - Bordeaux | BORDEAUX, 33000, France |
Completed | Clinique Paulmy - Bayonne | BAYONNE, 64100, France |
Completed | Clinique de Courlancy Reims | Reims, 51100, France |
Completed | Wojskowy Instytut Medyczny | Warszawa, 04-141, Poland |
Completed | Akademicki Szpital Kliniczny im. J. Mikulicza-Radeckiego | Wroclaw, 50 - 556, Poland |
Completed | Wojewodzkie Centrum Onkologii | Gdansk, 80-219, Poland |
Completed | Centrum Onkologii Ziemi Lubelskiej | Lublin, 20-090, Poland |
Completed | Hospital Universitario 12 de Octubre | Madrid, 28041, Spain |
Completed | Royal Marsden Hospital (London) | London, SW3 6JJ, United Kingdom |
Completed | Mount Vernon Hospital | Northwood, HA6 2RN, United Kingdom |
Completed | Cochin - Paris | PARIS, 75014, France |
Completed | CLINIQUE SAINTE CATHERINE | Avignon, 84000, France |
Completed | Hôpital de la Pitié-Salpétrière - Paris | PARIS, 75651, France |
Completed | IRCCS Policlinico San Matteo | Pavia, 27100, Italy |
Completed | IRCCS Centro di Riferimento Oncologico - CRO | Aviano, 33081, Italy |
Completed | Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Terminated | Newcastle General Hospital | Newcastle Upon Tyne, NE4 6BE, United Kingdom |
Terminated | CENTRE CATHERINE DE SIENNE | NANTES, 44020, France |
Terminated | Centre Alexis Vautrin - Vandoeuvre les Nancy | VANDOEUVRE LES NANCY, 54000, France |
Terminated | Institut Claudius Regaud - Toulouse | TOULOUSE, 31052, France |
Terminated | Hôpital de la Timone - Marseille | Marseille, 13385, France |
Terminated | Clinique de l'Orangerie | STRASBOURG, 67000, France |
Terminated | Hôpital du Nord - Marseille | MARSEILLE, 13015, France |
Terminated | A.O.U. di Perugia | Perugia, 06156, Italy |
Terminated | A.O.R.N. Antonio Cardarelli | Napoli, 80131, Italy |
Terminated | A.O. di Reggio Emilia | Reggio Emilia, 42100, Italy |
Terminated | AULSS 21 Legnago - Veneto | Legnago, 37045, Italy |
Terminated | Hospital Central de Asturias | Oviedo, 33006, Spain |
Terminated | Clínica Universitaria de Navarra | Pamplona, 31008, Spain |
Terminated | Instituto Valenciano de Oncología | Valencia, 46009, Spain |
Terminated | Hospital General Universitario Gregorio Marañón | Madrid, 28046, Spain |
Terminated | Allgemeines Krankenhaus der Stadt Wien Universitätskliniken | Wien, 1090, Austria |
Terminated | Landeskrankenhaus Salzburg | Salzburg, 5020, Austria |
Terminated | Tallaght Hospital | Dublin, 24, Ireland |
Terminated | Bon Secours Hospital | Cork, Ireland |
Primary Outcome
- Progression-Free Survivaldate_rangeTime Frame:From start of treatment of the first subject until 14 months later, assessed every 8 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Response Ratedate_rangeTime Frame:From start of treatment of the first subject until 14 months later, assessed every 8 Weeksenhanced_encryptionNoSafety Issue:
- Time to Progressiondate_rangeTime Frame:From start of treatment of the first subject until 14 months later, assessed every 8 Weeksenhanced_encryptionNoSafety Issue:
- Duration of Responsedate_rangeTime Frame:From start of treatment of the first subject until 14 months later, assessed every 8 Weeksenhanced_encryptionNoSafety Issue:
- Overall Survivaldate_rangeTime Frame:From start of treatment of the first subject until 14 months later, assessed every 8 Weeksenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2Additional Information
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