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Predictive Value of Drug Elimination Gene Polymorphisms on Clearance and Dose Adjustment of Sunitinib in Cancer Patients

NCT ID: NCT01098903

Last Updated: 2012-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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Sunitinib is an anticancer drug, but like most drugs, the effect varies from person to person. This is partly due to a variation in how well each person eradicates the drug from the body. This can lead to toxicity if the drug is eliminated slowly. Just as important is inadvertent underdosing in people who eliminate the drug quickly which may lead to a reduced anti-cancer effect. The investigators group has developed a battery of tests that may measure how an individual clears a drug from their body. The investigators intend to apply these tests to a group of patients taking sunitinib to see whether any test will help predict the level of sunitinib in the body and also the side effects. If a test seems to be promising from this study it may be possible to do a simple test on patients before they receive sunitinib so the best dose is chosen. The tests involve identifying the genes that are involved with drug elimination (CYP3A, ABCB1, ABCG2, OCT1, OATP) as well as directly measuring elimination using marker drugs (midazolam clearance and sestamibi liver clearance).

Detailed Description

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Conditions

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Cancer

Keywords

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sunitinib cancer pharmacogenomics pharmacokinetics Patients who have a malignancy and are going to be treated with sunitinib doseindividualism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sunitinib

Patients with a malignancy treated with sunitinib

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role collaborator

South West Sydney Local Health District

OTHER

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Heinz-Josef Klumpen

md

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Academic medical center Amsterdam

Amsterdam, , Netherlands

Site Status

Erasmus Medical Center, Daniel Den Hoed Cancer Center

Rotterdam, , Netherlands

Site Status

Countries

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Australia Netherlands

Other Identifiers

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HGWH0008

Identifier Type: -

Identifier Source: org_study_id