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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00492986

Collaborator

(none)

1,150

Enrollment

Locations

Arm

Duration (Months)

34.8

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: Nexavar (Sorafenib, BAY43-9006)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Nexavar (Sorafenib, BAY43-9006) Multikinase inhibitor: Sorafenib mono therapy 400 mg bid

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Nexavar (Sorafenib, BAY43-9006)

Multikinase inhibitor: Sorafenib mono therapy 400 mg bid

Outcome Measures

Primary Outcome Measures

Safety Parameters [Continously]

Secondary Outcome Measures

Collection of radiological evaluations [Continously]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Bruxelles - Brussel		Belgium	1000
2	Leuven		Belgium	3000
3	Århus C		Denmark	8000
4	Bordeaux		France	33000
5	Lyon Cedex		France	69008
6	Villejuif		France	94805
7	München	Bayern	Germany	81377
8	Darmstadt	Hessen	Germany	64276
9	Düsseldorf	Nordrhein-Westfalen	Germany	40225
10	Koblenz	Rheinland-Pfalz	Germany	56068
11	Mainz	Rheinland-Pfalz	Germany	55131
12	Homburg	Saarland	Germany	66421
13	Dresden	Sachsen	Germany	01307
14	Lübeck	Schleswig-Holstein	Germany	23538
15	Berlin		Germany	12200
16	Hamburg		Germany	20251
17	Milano		Italy	20133
18	Modena		Italy	41124
19	Pavia		Italy	27100
20	Perugia		Italy	06156
21	Reggio Emilia		Italy	42100
22	Amsterdam		Netherlands	1105 AZ
23	Warszawa		Poland	04-141
24	Oviedo	Asturias	Spain	33006
25	Barcelona		Spain	08035
26	Madrid		Spain	28040
27	Göteborg		Sweden	413 45
28	Stockholm		Sweden	171 76
29	Basel	Basel-Stadt	Switzerland	4031
30	Genève		Switzerland	1211
31	Glasgow	Stratchclyde	United Kingdom	G11 6NT
32	Sutton	Surrey	United Kingdom	SM2 5PT
33	London		United Kingdom	SW3 6JJ