Trial Condition(s):

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

Bayer Identifier:

11941

ClinicalTrials.gov Identifier:

NCT00492986

EudraCT Number:

2005-002524-34

Study Completed

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

Inclusion Criteria
- 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)
Exclusion Criteria
- 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
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Phase
3
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätskliniken des Saarlandes

Homburg, Germany, 66421

Status
Completed
 
Locations

Klinikum Darmstadt

Darmstadt, Germany, 64276

Status
Completed
 
Locations

Praxis Hr. Dr. J. Thomalla

Koblenz, Germany, 56068

Status
Completed
 
Locations

Royal Marsden NHS Trust (Surrey)

Sutton, United Kingdom, SM2 5PT

Status
Completed
 
Locations

Western Infirmary

Glasgow, United Kingdom, G11 6NT

Status
Completed
 
Locations

Institut Gustave Roussy - Villejuif

VILLEJUIF, France, 94805

Status
Completed
 
Locations

Centre Léon Bérard

LYON CEDEX, France, 69008

Status
Completed
 
Locations

IRCCS Istituto Nazionale Tumori

Milano, Italy, 20133

Status
Completed
 
Locations

A.O.U. di Modena Policlinico

Modena, Italy, 41124

Status
Completed
 
Locations

A.O. di Perugia

Perugia, Italy, 06156

Status
Completed
 
Locations

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Academisch Medisch Centrum Universiteit van Amsterdam

AMSTERDAM, Netherlands, 1105 AZ

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Status
Completed
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

Status
Completed
 
Locations

LMU Klinikum der Universität München - Großhadern

München, Germany, 81377

Status
Completed
 
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20251

Status
Completed
 
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

Medizinische Einrichtungen der Heinrich-Heine-Universität

Düsseldorf, Germany, 40225

Status
Completed
 
Locations

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Royal Marsden Hospital (London)

London, United Kingdom, SW3 6JJ

Status
Completed
 
Locations

Hôpital Saint André - Bordeaux

BORDEAUX, France, 33000

Status
Completed
 
Locations

Wojskowy Instytut Medyczny

Warszawa, Poland, 04-141

Status
Completed
 
Locations

A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

Status
Completed
 
Locations

Hospital Central de Asturias

Oviedo, Spain, 33006

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Institut Jules Bordet/Jules Bordet Instituut

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
Locations

Aarhus Universitetshospital

Århus C, Denmark, 8000

Status
Completed
 
Locations

Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Hôpital Cantonal Universitaire de Genève

Genève, Switzerland, 1211

Status
Completed
 

Trial Design