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
  • - The patient must provide written informed consent prior to receiving BAY 43-9006
    - The male or female patient must be at least 18 years of age
    - The patient must have advanced Renal Cell Carcinoma
    - The patient must have failed at least one prior systemic established therapy for advanced RCC (e. g. IL-2, IFN-a), or must have been unable to tolerate systemic therapy for advanced RCC, or is deemed by the Investigator to be unsuited for systemic therapy for advanced RCC
    - A patient, who has received prior systemic and local therapies, must have completely recovered from acute toxicity (i. e. resolved back to CTCAE Grade 1 or less, or is considered as not going to resolve), if any, prior to study entry
    - The patient must be, in the Investigator's opinion, reasonably likely to benefit from treatment with BAY 43-9006 as a single agent
    - The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
    - The patient will not require other systemic anti-cancer chemotherapy, immunotherapy (including monoclonal antibodies) or hormonal therapy, except for bisphosphonates while taking BAY 43-9006
    - Both male and female patients must use adequate barrier birth control methods (oral contraceptives, injectable contraceptives, intrauterine devices, condoms, sterilization) during their participation in the protocol. The birth control methods must be used for 4 weeks for female patients and for 3 months for male patients after discontinuation of treatment with sorafenib
    - For patients, who have had major surgery, the wound must be completely healed prior to receiving BAY 43-9006 treatment (4 weeks)
  • - Patients who are currently enrolled in or have previously participated in any other sorafenib trial
    - Patients, who are eligible for or do have access to any other sorafenib clinical trial as to the knowledge of the Investigator
    - Patients who have a life expectancy of less than 2 months
    - Patients with metastatic brain or meningeal tumors
    - Patients are excluded who require any of the following:
    - Investigational drug therapy during the treatment with sorafenib or within 30 days prior to their first dose of sorafenib
    - Concomitant Rifampicin
    - Concomitant St. John's Wort (Hypericum perforatum) Warfarin is allowed; however, for patients receiving concomitant warfarin therapy close monitoring of Prothrombin Time (PT) should be performed (please note that no laboratory data are collected in this study)
    - Women who are pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of study drug (please note that no laboratory data are collected in this study)
    - Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity)
    - Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTc > 0.45-0.47 second)
    - Patients with active coronary artery disease or ischemia
    - Patients with Child-Pugh class C hepatic impairment
    - Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis
    - Patients with active uncontrolled hypertension
    - Patients with recent or active bleeding diathesis
    - Patients with any medical condition which could jeopardize their safety while taking an investigational drug

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