Phase I Pharmacokinetic and Pharmacodynamic Study of Pazopanib in Children With Soft Tissue Sarcoma and Other Refractory Solid Tumors: A Children’s Oncology Group Phase I Consortium Report
作者： Julia L. Glade Bender , Alice Lee , Joel M. Reid , Sylvain Baruchel , Timothy Roberts
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摘要: Purpose Pazopanib, an oral multikinase angiogenesis inhibitor, prolongs progression-free survival in adults with soft tissue sarcoma (STS). A phase I pharmacokinetic and pharmacodynamic study of two formulations pazopanib was performed children STS or other refractory solid tumors. Patients Methods Pazopanib (tablet formulation) administered once daily 28-day cycles at four dose levels (275 to 600 mg/m2) using the rolling-six design. Dose determination for a powder suspension initiated 50% maximum-tolerated (MTD) intact tablet. Ten patients underwent dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) scanning baseline 15 ± 2 days after initiation tablet MTD. Results Fifty-three were enrolled; 51 eligible (26 males; median age, 12.9 years; range, 3.8 23.9 years). Hematologic nonhematologic toxicities generally mild, dose-limiting lipase, amylase, ALT elevation, proteinuria, an...
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