EUCTR2008-005438-57-NLActive, not recruitingNot Applicable
Predictive value of drug elimination gene polymorphisms on clearance and dose adjustment of sunitinib (Sutent, SU11248) in patients with cancer - CLEARS
Academic Medical Centre0 sites45 target enrollmentStarted: September 3, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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
- •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
Investigators
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