Predictive value of drug elimination gene polymorphisms on clearance and dose adjustment of sunitinib (Sutent, SU11248) in patients with cancer - CLEARS
- Conditions
- The main group are patients with renal cell cancer currently being or about to be treated with sunitinib. Other diseases with efficacy of sunitinib are Gastro Intestinal Stromal cell tumour (GIST).
- Registration Number
- EUCTR2008-005438-57-NL
- Lead Sponsor
- Academic Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
• Age >18
• A malignancy treated with single agent sunitinib
• ECOG 0, 1 or 2 at time of study accruement
• Any stable dose of therapy with sunitinib (defined as no dose change
within 3 weeks prior to blood collection for pharmacokinetics)
• Adequate liver and renal function defined as serum bilirubin concentration
less than 2 x ULN, AST and ALT less than 2.5 x ULN, serum creatinine
concentration less than 2 x ULN
• No known primary liver disease and no other severe or uncontrolled
concurrent medical condition within the first 3 months of treatment with
sunitinib.
• Patients who have participated on other clinical studies of sunitinib will be
suitable for this study.
• Signed informed consent
• Patients must not have Class ¾ cardiac problems as defined by the New
York Heart Association criteria or any other severe or uncontrolled
concurrent medical disease.
• Patients must not be pregnant or nursing and must be using an effective
contraception method
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Patients who are unable to sign informed consent
• Patients unable to give blood
• Patients with known midazolam allergies will not be included
• Patients must not be pregnant or nursing and must be using an effective
contraception method
• Patients who had a bone-marrow-transplantation prior to sunitinib
Treatment
• Patients must not be taking routine systemic corticoid therapy
• Patients must not be taking therapeutic warfarin or warfarin derivates
doses as anticoagulation at the time of study tests with an at least 2 weeks
warfarin free period of time prior. Patients requiring anticoagulation may
use low-molecular weight heparin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method