PBTC-020: A PHASE I CLINICAL TRIAL OF AZD2171 IN CHILDREN

点击翻译按钮获取中文摘要

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. PBTC-020 is a multi-center pediatric phase I trial of AZD2171 that will be performed in children and adolescents with recurrent or refractory tumors of the central nervous system, to determine the maximum tolerated dose (MTD) and safety profile of AZD2171 in this population. AZD2171 will be administered by mouth once daily for 28 consecutive days in two strata: a) Stratum I: those who are not receiving enzyme inducing anticonvulsant drugs (EIACD) and b) Stratum II: those who are receiving enzyme inducing anticonvulsant drugs (EIACD). Patients will be treated with escalating doses of AZD2171. Each course will last for 28 consecutive days and treatment may continue without breaks for up to 13 courses or one year. Dose escalations will be performed with each cohort in each stratum.