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

Completed

• Conditions: Renal cell cancer; Cancer; Malignant neoplasm of kidney, except renal pelvis

• Registration Number: ISRCTN46317673
• Lead Sponsor: Academic Medical Center (AMC), Department of Urology (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients >18 years
2. Eastern Cooperative Oncology Group (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 computed tomography (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

Exclusion Criteria

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