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.

Academic Medical Center, University of Amsterdam,Department of Urology0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•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.

发起方

Academic Medical Center, University of Amsterdam,Department of Urology