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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 PBTC-020是一项AZD 2171的多中心儿科I期试验，将在患有复发性或难治性中枢神经系统肿瘤的儿童和青少年中进行，以确定AZD 2171在该人群中的最大耐受剂量（MTD）和安全性特征。AZD 2171将在两个分层中每日一次口服给药，连续28天：a）分层I：未接受酶诱导抗惊厥药物（EIACD）的受试者，和B）分层II：正在接受酶诱导抗惊厥药物（EIACD）的受试者。患者将接受递增剂量的AZD 2171治疗。每个疗程将持续连续28天，治疗可以连续进行13个疗程或一年。将对每个分层中的每个队列进行剂量递增。

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.