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
| ISRCTN | ISRCTN46317673 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46317673 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 31/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S.A. Lagerveld-Zaaijer
Scientific
Scientific
Academic Medical Center (AMC)
Department of Urology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5666030 |
|---|---|
| S.A.Zaaijer@amc.uva.nl |
Study information
| 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 |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 01/07/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Center (AMC), Department of Urology (The Netherlands)
Not defined
Not defined
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Hospital/treatment centre
Academic Medical Center (AMC), Department of Urology (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
