check_circleStudy Completed

Carcinoma, Renal Cell

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

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
1150
Trial Dates
October 2005 - November 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Universitätskliniken des SaarlandesHomburg, 66421, Germany
Completed
Klinikum DarmstadtDarmstadt, 64276, Germany
Completed
Praxis Hr. Dr. J. ThomallaKoblenz, 56068, Germany
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Completed
Western InfirmaryGlasgow, G11 6NT, United Kingdom
Completed
Institut Gustave Roussy - VillejuifVILLEJUIF, 94805, France
Completed
Centre Léon BérardLYON CEDEX, 69008, France
Completed
IRCCS Istituto Nazionale TumoriMilano, 20133, Italy
Completed
A.O.U. di Modena PoliclinicoModena, 41124, Italy
Completed
A.O. di PerugiaPerugia, 06156, Italy
Completed
IRCCS Policlinico San MatteoPavia, 27100, Italy
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Academisch Medisch Centrum Universiteit van AmsterdamAMSTERDAM, 1105 AZ, Netherlands
Completed
Sahlgrenska UniversitetssjukhusetGöteborg, 413 45, Sweden
Completed
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany
Completed
LMU Klinikum der Universität München - GroßhadernMünchen, 81377, Germany
Completed
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20251, Germany
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Completed
Medizinische Einrichtungen der Heinrich-Heine-UniversitätDüsseldorf, 40225, Germany
Completed
Universitätsklinikum Schleswig-Holstein / AÖRLübeck, 23538, Germany
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Royal Marsden Hospital (London)London, SW3 6JJ, United Kingdom
Completed
Hôpital Saint André - BordeauxBORDEAUX, 33000, France
Completed
Wojskowy Instytut MedycznyWarszawa, 04-141, Poland
Completed
A.O. di Reggio EmiliaReggio Emilia, 42100, Italy
Completed
Hospital Central de AsturiasOviedo, 33006, Spain
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
Institut Jules Bordet/Jules Bordet InstituutBRUXELLES - BRUSSEL, 1000, Belgium
Completed
Aarhus UniversitetshospitalÅrhus C, 8000, Denmark
Completed
Karolinska Universitetssjukhuset i SolnaStockholm, 171 76, Sweden
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Completed
Hôpital Cantonal Universitaire de GenèveGenève, 1211, Switzerland

Primary Outcome

  • Safety Parameters
    date_rangeTime Frame:
    Continously
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Collection of radiological evaluations
    date_rangeTime Frame:
    Continously
    enhanced_encryption
    Safety Issue:
    no

Trial design

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 Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1