Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
Optimizing Pazopanib Exposure in RCC Patients Through Therapeutic Drug Monitoring Followed by Intrapatient Dose Escalation
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).
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