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van CCT (UK)


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van CCT (UK)


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.


- candidate number1950
- NTR NumberNTR574
- ISRCTNISRCTN46317673
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-feb-2006
- Date Registered NTR26-jan-2006
- Secondary IDsN/A 
- Public TitleA 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.
- Scientific TitleA 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.
- ACRONYMRCC: neoadjuvant therapy with BAY 43-9006
- hypothesisIn 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%.
- Healt Condition(s) or Problem(s) studiedRenal cell carcinoma
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type-
- Studytypeintervention
- planned startdate 1-mrt-2006
- planned closingdate1-jul-2008
- Target number of participants30
- InterventionsAll patients will receive BAY 43-9006 400 mg bid for the period of 8 weeks.
- Primary outcomeParameters: 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 outcomeParameters: toxicity. 1. Toxicity by means of the remaining laboratory assessments; 2. Number and severity of AEs; 3. Number and severity of SAEs.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES S.A. Zaaijer
- CONTACT for SCIENTIFIC QUERIES I.P.E.D. Kummerlin
- Sponsor/Initiator Academic Medical Center (AMC), Department of Urology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Urology
- PublicationsN/A
- Brief summaryBAY 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.
- Main changes (audit trail)
- RECORD26-jan-2006 - 6-mrt-2006


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