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- W2337659464 abstract "3561 Background: Sunitinib is an oral multitargeted tyrosine kinase inhibitor of VEGF, PDGF, c-KIT, and flt-3 receptors. This study was conducted to define the dose limiting toxicities (DLT) and to determine the maximum tolerated dose (MTD) of sunitinib in children with relapsed or refractory solid tumors. Methods: Sunitinib was administered orally once daily in 6 week cycles (4 weeks on / 2 weeks off). Cohorts of 3–6 pts (≥ 2 to ≤ 21 yr) were enrolled at a starting dose level of 20 mg/m2/d, based on the adult recommended dose of 50 mg/d. Weekly 24-hour trough plasma concentrations of sunitinib and the active metabolite, SU12662, were determined. Results: 12 pts (8 male), median age 14.6 (range 10.6–20.6) yrs, were enrolled. 3/6 pts at the initial dose level of 20 mg/m2/d had DLT: grade 2 systolic dysfunction, grade 3 anorexia, and grade 4 neutropenia. Two pts developed grade 2 hypothyroidism. 2/6 pts at dose level -1 (15 mg/m2/d) had DLTs: grade 3 systolic dysfunction and grade 3 ALT. Of the 2 pts with cardiotoxicity, one required treatment with digoxin and lisinopril for symptom control; both improved several weeks following sunitinib discontinuation. No objective responses were observed. The median d21 steady-state trough sunitinib plasma concentrations were 24.6 (range 6.0–37.7) and 37.4 (24.2–62.9) ng/mL at the 15 and 20 mg/m2 dose levels, respectively. Conclusions: Sunitinib at a dose of 20 mg/m2/d exceeded the MTD in pediatric patients included in this study. The steady-state PK profile of sunitinib in children appears comparable to that observed in adults. Due to the observed and emerging concerns of cardiotoxicity, further pediatric evaluation of sunitinib is being undertaken in pts not previously treated with anthracyclines or radiation fields involving the heart. No significant financial relationships to disclose." @default.
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- W2337659464 date "2008-05-20" @default.
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- W2337659464 title "A pediatric phase I trial and pharmacokinetic (PK) study of sunitinib: A Children’s Oncology Group Phase I Consortium study" @default.
- W2337659464 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.3561" @default.
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