Contact information
Type
Scientific
Contact name
Dr S.A. Lagerveld-Zaaijer
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Urology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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%.
Ethics approval(s)
Not provided at time of registration
Study design
Single center open-label uncontrolled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Renal cell cancer
Intervention
All patients will receive BAY 43-9006 400 mg twice a day (bid) for the period of 8 weeks.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
BAY 43-9006 [sorafenib (Nexavar®)]
Primary outcome measure
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 measures
Parameters: toxicity.
1. Toxicity by means of the remaining laboratory assessments
2. Number and severity of adverse events (AEs)
3. Number and severity of serious adverse events (SAEs)
Overall study start date
01/03/2006
Overall study end date
01/07/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
30
Participant 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
Recruitment start date
01/03/2006
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC), Department of Urology (The Netherlands)
Sponsor details
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Not defined
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Center (AMC), Department of Urology (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|