check_circleStudy Completed
Carcinoma, Renal Cell
Bayer Identifier:
11941
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
An Open-Label, Non-Comparative, Phase III Study of the Raf-Kinase Inhibitor BAY 43-9006 as a Subsequent to First-Line Therapy in Patients with Advanced Renal Cell Carcinoma
Trial purpose
Purpose of the study:
The purpose of this study is to make sorafenib available for patients with advanced Renal Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring second line treatment), and who do not have access to or are not eligible for other clinical trials with sorafenib and who may benefit from treatment with sorafenib.
Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a single agent. Patients may continue treatment until Disease Progression, intolerable toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any further from treatment.
Overall, participation in the study will help determine the following:
- Find out if patients receiving Sorafenib will live longer
- Find out if Sorafenib helps to slow the worsening of kidney cancer
- Find out if Sorafenib has an effect on the tumours
The purpose of this study is to make sorafenib available for patients with advanced Renal Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring second line treatment), and who do not have access to or are not eligible for other clinical trials with sorafenib and who may benefit from treatment with sorafenib.
Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a single agent. Patients may continue treatment until Disease Progression, intolerable toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any further from treatment.
Overall, participation in the study will help determine the following:
- Find out if patients receiving Sorafenib will live longer
- Find out if Sorafenib helps to slow the worsening of kidney cancer
- Find out if Sorafenib has an effect on the tumours
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
1150Trial Dates
October 2005 - November 2008Phase
Phase 3Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Universitätskliniken des Saarlandes | Homburg, 66421, Germany |
Completed | Klinikum Darmstadt | Darmstadt, 64276, Germany |
Completed | Praxis Hr. Dr. J. Thomalla | Koblenz, 56068, Germany |
Completed | Royal Marsden NHS Trust (Surrey) | Sutton, SM2 5PT, United Kingdom |
Completed | Western Infirmary | Glasgow, G11 6NT, United Kingdom |
Completed | Institut Gustave Roussy - Villejuif | VILLEJUIF, 94805, France |
Completed | Centre Léon Bérard | LYON CEDEX, 69008, France |
Completed | IRCCS Istituto Nazionale Tumori | Milano, 20133, Italy |
Completed | A.O.U. di Modena Policlinico | Modena, 41124, Italy |
Completed | A.O. di Perugia | Perugia, 06156, Italy |
Completed | IRCCS Policlinico San Matteo | Pavia, 27100, Italy |
Completed | Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Completed | Hospital Clínico Universitario San Carlos | Madrid, 28040, Spain |
Completed | Academisch Medisch Centrum Universiteit van Amsterdam | AMSTERDAM, 1105 AZ, Netherlands |
Completed | Sahlgrenska Universitetssjukhuset | Göteborg, 413 45, Sweden |
Completed | Johannes-Gutenberg-Universität Mainz | Mainz, 55131, Germany |
Completed | LMU Klinikum der Universität München - Großhadern | München, 81377, Germany |
Completed | Universitätsklinikum Hamburg Eppendorf (UKE) | Hamburg, 20251, Germany |
Completed | Charité Campus Benjamin Franklin | Berlin, 12200, Germany |
Completed | Medizinische Einrichtungen der Heinrich-Heine-Universität | Düsseldorf, 40225, Germany |
Completed | Universitätsklinikum Schleswig-Holstein / AÖR | Lübeck, 23538, Germany |
Completed | Medizinische Fakultät Carl Gustav Carus | Dresden, 01307, Germany |
Completed | Royal Marsden Hospital (London) | London, SW3 6JJ, United Kingdom |
Completed | Hôpital Saint André - Bordeaux | BORDEAUX, 33000, France |
Completed | Wojskowy Instytut Medyczny | Warszawa, 04-141, Poland |
Completed | A.O. di Reggio Emilia | Reggio Emilia, 42100, Italy |
Completed | Hospital Central de Asturias | Oviedo, 33006, Spain |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | Institut Jules Bordet/Jules Bordet Instituut | BRUXELLES - BRUSSEL, 1000, Belgium |
Completed | Aarhus Universitetshospital | Århus C, 8000, Denmark |
Completed | Karolinska Universitetssjukhuset i Solna | Stockholm, 171 76, Sweden |
Completed | Universitätsspital Basel | Basel, 4031, Switzerland |
Completed | Hôpital Cantonal Universitaire de Genève | Genève, 1211, Switzerland |
Primary Outcome
- Safety Parametersdate_rangeTime Frame:Continouslyenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Collection of radiological evaluationsdate_rangeTime Frame:Continouslyenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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