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Predictive Value of Drug Elimination Gene Polymorphisms on Clearance and Dose Adjustment of Sunitinib (Sutent, SU11248) in Patients With Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

Predictive Value of Drug Elimination Gene Polymorphisms on Clearance and Dose Adjustment of Sunitinib (Sutent, SU11248) in Patients With Cancer


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To observe the correlation between ABCB1 polymorphisms in Exons 13, 22 and 27 and the clearance of sunitinib at steady state.

Outcome Description:

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)

Outcome Time Frame:

4 weeks

Safety Issue:

No

Authority:

Australia: National Health and Medical Research Council

Study ID:

HGWH0008

NCT ID:

NCT01098903

Start Date:

January 2009

Completion Date:

December 2011

Related Keywords:

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

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