Clinical trial NCT00492986: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Renal Cell
Keywords: Renal Cell Cancer (RCC)
Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 1150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Safety Parameters
timeFrame: Continously
Secondary outcomes:
measure: Collection of radiological evaluations
timeFrame: Continously
Other outcomes:
Locations:
city: Bruxelles - Brussel
country: Belgium
city: Leuven
country: Belgium
city: Århus C
country: Denmark
city: Bordeaux
country: France
city: Lyon Cedex
country: France
city: Villejuif
country: France
city: München
country: Germany
state: Bayern
city: Darmstadt
country: Germany
state: Hessen
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
state: Rheinland-Pfalz
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Homburg
country: Germany
state: Saarland
city: Dresden
country: Germany
state: Sachsen
city: Lübeck
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Milano
country: Italy
city: Modena
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Reggio Emilia
country: Italy
city: Amsterdam
country: Netherlands
city: Warszawa
country: Poland
city: Oviedo
country: Spain
state: Asturias
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Göteborg
country: Sweden
city: Stockholm
country: Sweden
city: Basel
country: Switzerland
state: Basel-Stadt
city: Genève
country: Switzerland
city: Glasgow
country: United Kingdom
state: Stratchclyde
city: Sutton
country: United Kingdom
state: Surrey
city: London
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: