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A multicenter phase I study of pazopanib in combination with paclitaxel in first-line treatment of patients with advanced solid tumors.
Molecular Cancer Therapeutics (2015)
  • Miguel A. Villalona Calero, M.D.
Abstract
This study was designed to evaluate the safety, pharmacokinetics, and clinical activity of pazopanib combined with paclitaxel to determine the recommended phase II dose in the first-line setting in patients with advanced solid tumors. Patients were enrolled in a 3+3 dose-escalation design to determine the maximum tolerated regimen (MTR) of once daily pazopanib plus paclitaxel administered every 3 weeks at four dose levels (DL1-4). Safety, pharmacokinetics, pharmacogenetics, and disease assessments were performed. Twenty-eight patients received treatment. One patient at DL1 had dose-limiting toxicity (DLT) of elevated hepatic enzymes. After pazopanib discontinuation, liver enzyme concentrations remained high until a concurrent medication, simvastatin, was discontinued. This patient had the defective CYP2C8*3*3 genotype. At DL2, 1 patient had DLT of elevated hepatic enzymes with rash and 1 patient had DLT of rash. The MTR was paclitaxel 150 mg/m(
Publication Date
February, 2015
Citation Information
Miguel A. Villalona Calero. "A multicenter phase I study of pazopanib in combination with paclitaxel in first-line treatment of patients with advanced solid tumors." Molecular Cancer Therapeutics Vol. 14 Iss. 2 (2015) p. 461 - 469
Available at: http://works.bepress.com/miguel-villalonacalero/91/