Predictive Value of Drug Elimination Gene Polymorphisms on Clearance and Dose Adjustment of Sunitinib in Cancer Patients (CLEARSUN)
|ClinicalTrials.gov Identifier: NCT01098903|
Recruitment Status : Completed
First Posted : April 5, 2010
Last Update Posted : July 12, 2012
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||52 participants|
|Official Title:||Predictive Value of Drug Elimination Gene Polymorphisms on Clearance and Dose Adjustment of Sunitinib (Sutent, SU11248) in Patients With Cancer|
|Study Start Date :||January 2009|
|Primary Completion Date :||June 2011|
|Study Completion Date :||December 2011|
Patients with a malignancy treated with sunitinib
- To observe the correlation between ABCB1 polymorphisms in Exons 13, 22 and 27 and the clearance of sunitinib at steady state. [ Time Frame: 4 weeks ]A blood sample will be drawn on day 1 of any treatment cycle and at steady state of the same cycle (between Day 21 and 28 inclusive)
- To determine whether ABCB1 genotype correlates with toxicity-adjusted dose of sunitinib [ Time Frame: 3 months ]Toxicity adjustments will be collected within the first 3 months and correlated with the ABCB1 genotypes.
- To determine the pharmacokinetics at steady state of the sunitinib treatment. [ Time Frame: 4 weeks ]A blood sample will be drawn on day 1 of treatment cycle and at steady state of the same cycle (between Day 21 and 28 inclusive). The time of the blood collection are at day1 and in the 4th week: pre-drug administration then at 4 hours, 8 hours and 24 hours after drug intake.
- To examine correlations between ABCB1 genotype and toxicity grade according to CTC criteria. [ Time Frame: 3 months ]The toxicity data of the first 3 months of treatment will be collected.
- To examine the correlation between genotype haplotype of other drug elimination genes, such as organic anion transporter proteins (OATP) and other biliary efflux proteins such as MRP2, BCRP with sunitinib clearance and toxicity adjusted dose. [ Time Frame: 3 months ]Investigations of drugelimination and clearance taken with in the first 4 weeks of the study will be collected as well as the toxicity data and dose adjustments within the first 3 month of treatment.
- Correlation of drug elimination phenotype test (sestamibi liver scan and Midazolam clearance) with sunitinib clearance [ Time Frame: 4 weeks ]sestamibi liver scan and midazolam clearance test will be performed pre-treatment and at steady state (sometime between day 21-28)of study participation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098903
|Australia, New South Wales|
|Westmead, New South Wales, Australia, 2145|
|Academic medical center Amsterdam|
|Amsterdam, Netherlands, 1105AZ|
|Erasmus Medical Center, Daniel Den Hoed Cancer Center|
|Rotterdam, Netherlands, 3075EA|