Condition category
Cancer
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
31/07/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

Not provided at time of registration

Study design

Single center open-label uncontrolled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

BAY 43-9006 [sorafenib (Nexavar®)]

Primary outcome measures

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 trial start date

01/03/2006

Overall trial end date

01/07/2008

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes