A single center open-label uncontrolled study to investigate tumour response and vascularization changes in neoadjuvant therapy with BAY 43-9006 single agent therapy in patients with operable renal cell cancer.
- Conditions
- All patients with renal cell cancer who are candidates for a partial or radical nephrectomy, will be asked to participate in the BAY 43-9006 study.
- Registration Number
- NL-OMON26901
- Lead Sponsor
- Academic Medical Center, University of Amsterdam,Department of Urology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
1. Patients > 18 years;
2. ECOG = 1(2);
3. Candidates for a radical or partial nephrectomy who are fit for surgery;
4. At least one uni-dimensional measurable lesion, measured by CT-scan;
5. Adequate bone marrow function;
6. Adequate liver function;
7. Adequate renal function;
8. Adequate coagulation;
9. Men and women must have adequate barrier birth control before and during and for 1 week after the trial.
10.Signed informed consent
1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY43- 9006;
2. History of cardiac disease congestive heart failure, cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension;
3. History of chronic hepatitis B or C and HIV infection;
4. Patients with seizure disorders (requiring medication);
5. Patients with evidence or history of bleeding diathesis;
6. Other investigational drug therapy within 30 days;
7. Women of childbearing potential with a positive pregnancy test within 7 days before start treatment;
8. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study;
9. Unable to swallow oral medication;
10. Tumour/ disease specific criteria: chronic diarrhoea, bowel obstruction, degree of malnutrition, malabsorption;
11. Major surgery within 4 weeks before screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parameters: tumour response and vascularization. <br>1. Tumour reduction measured by CT;<br>2. Quantitative changes in perfusion as measured by means of contrast enhanced ultrasound and various image processing techniques.<br>
- Secondary Outcome Measures
Name Time Method Parameters: toxicity.<br>1. Toxicity by means of the remaining laboratory assessments;<br>2. Number and severity of AEs;<br>3. Number and severity of SAEs.