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ID
Source
Brief title
Health condition
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.
Sponsors and support
Department of Urology
Intervention
Outcome measures
Primary outcome
Parameters: tumour response and vascularization.
1. Tumour reduction measured by CT;
2. Quantitative changes in perfusion as measured by means of contrast enhanced ultrasound and various image processing techniques.
Secondary outcome
Parameters: toxicity.
1. Toxicity by means of the remaining laboratory assessments;
2. Number and severity of AEs;
3. Number and severity of SAEs.
Background summary
BAY 43-9006 or Sorafenib (family of the RAF kinase inhibitors) is an orally bio available anti-angiogenic drug with anti-proliferative and anti-angiogenic properties which targets the tumour and neo-vasculature. In view of good pre-clinical and clinical results, it was decided to investigate BAY 43-9006 in a translational study to monitor the effects of BAY 43-9006 in a neo-adjuvant setting and to evaluate the benefit in patients with renal cell cancer in the future. Previous studies with BAY 43-9006 in renal cell cancer were performed in patients with advanced renal cell cancer.
Study objective
In view of good pre-clinical and clinical results, it is thought that patients with renal cell cancer will benefit from BAY 43-9006 in a neoadjuvant setting.We anticipate a benefit with the treatment of BAY 43-9006 when there is a tumour reduction more than 30%.
Intervention
All patients will receive BAY 43-9006 400 mg bid for the period of 8 weeks.
P.O. Box 22660
S.A. Zaaijer
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl
P.O. Box 22660
S.A. Zaaijer
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl
Inclusion criteria
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
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL530 |
| NTR-old | NTR574 |
| Other | : N/A |
| ISRCTN | ISRCTN46317673 |