Optimization of Pazopanib Exposition in Patients with Renal Cell Carcinoma by Therapeutic Drug Monitoring followed by Individual Dose Escalation.
This is an open, multi-center, intraindividual dose-optimization study. Patients with locally advanced or metastatic renal cell carcinoma receive 800 mg Pazopanib daily. After 14 days the Pazopanib plasma concentration is determined. In patients who show good tolerability and plasma trough levels of ≤ 20 µg/mLthe daily dose is increased in 200 mg steps until plasma trough levels of \> 20 µg/mL are achieved or dose-limiting toxicities occur, a daily dose of 1600 mg is reached, or there is disease progression. After each dose optimization the plasma concentration is determined after 14 days (day 11-15). If indicated, dose optimization is performed 21 days after the previous dose optimization (on day 18-24).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Gesundheitszentrum Holzminden
Holzminden, Lower Saxony, Germany
Private Practice Kamann
Leipzig, Saxony, Germany
Private Practice Geiges
Berlin, Germany
Determine if in patients with a Pazopanib plasma trough level of ≤ 20 μg/mL a plasma trough level of > 20 ≤g/mL can be achieved by dose escalation.
Time frame: 14 days after each dose optimization.
Comparison of tumor response of patients with normal and low Pazopanib plasma trough levels.
Comparison of patients with normal Pazopanib plasma trough levels ("normal plasma level patients; NPLP) with patients with low Pazopanib plasma trough levels ("Low plasma level patients"; LPLP) with regard to the therapeutic result.
Time frame: Up to 28 days after last dose.
Objective remission rate.
Time frame: Up to 28 days after last dose.
Progression free survival.
Time frame: Up to 28 days after last dose.
Overall survival.
Time frame: Up to 28 days after last dose.
Comparison of LPLP in whom the plasma trough level could be optimized successfully and LPLP in whom the plasma trough level could not be optimized with regard to above parameters.
Time frame: Up to 28 days after last dose.
Correlation of plasma trough levels and side effects, especially high blood pressure.
Time frame: Up to 28 days after last dose.
Correlation of the occurrence of high blood pressure with oncological result (response rate).
Time frame: Up to 28 days after last dose.
Recording of demographic data, compliance, concomitant medication, and correlation with plasma trough levels (LPLP / NPLP).
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Time frame: Up to 28 days after last dose.
Examination of life quality.
Time frame: Up to 28 days after last dose.