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

Phase 1

Conditions: Advanced Renal Cell Carcinoma

Registration Number: EUCTR2005-002524-34-GB

Lead Sponsor: BAYER Healthcare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.The patient must provide written informed consent prior to receiving BAY 43-9006.
2.The male or female patient must be at least 18 years of age.
3.The patient must have advanced Renal Cell Carcinoma.
4.The patient must have failed at least one prior systemic established therapy for advanced RCC (e. g., IL-2, IFN-alpha), 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.
5.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.
6.The patient must be, in the Investigator’s opinion, reasonably likely to benefit from treatment with BAY 43-9006 as a single agent.
7.The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
8.The patient will not require other systemic anti-cancer chemotherapy, immunotherapy (including monoclonal antibodies), signal transduction inhibitors or hormonal therapy, except for bisphosphonates while taking BAY 43-9006.
9.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 BAY 43-9006.
10.For patients, who have had major surgery, the wound must be completely healed prior to receiving BAY 43-9006 treatment (4 weeks).
11. Patients with metastatic brain disease which is active or progressive despite previous radiation, radiosurgical or surgical therapy (including gamma knife) are eligible for this protocol, provided they have recovered from any treatment-related toxicity. Patients whose metastatic brain lesions have been surgically removed are also eligible for this protocol. Patients with brain metastases should be observed carefully for any central nervous system symptoms or signs of worsening. Brain metastases are excluded as target lesions for RECIST unless they are the only lesions being followed for the patient.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients who have previously been enrolled in any other BAY 43-9006 clinical trial are not eligible for enrolment in this protocol. However, patients who are being treated with Bay 43-9006 in another trial can be enrolled in this study if the trial they are currently participating in is being discontinued, and if the patient has not already experienced progressive disease on sorafenib treatment.
2.Patients, who are eligible for or do have access to any other BAY 43-9006 clinical trial as to the knowledge of the Investigator.
3.Patients who have a life expectancy of less than 2 months.

5.Patients are excluded who require any of the following:
a.Investigational drug therapy during the treatment with BAY 43-9006 or within 30 days prior to their first dose of BAY 43-9006.
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).
6.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).
7.Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity)
8.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).
9.Patients with active coronary artery disease or ischemia.
10.Patients with Child Pugh class C hepatic impairment.
11.Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis.
12.Patients with active uncontrolled hypertension.
13.Patients with recent or active bleeding diathesis.
14.Patients with any medical condition which could jeopardize their safety while taking an investigational drug.
15. Severe hypersensitivity to sorafenib or any of the excipients.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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