PBTC016: A PHASE I, MOLECULAR BIOLOGY AND PHASE II STUDY OF LAPATINIB (GW5720A

PBTC016：拉帕替尼 (GW5720A) 的 I 期、分子生物学和 II 期研究

• 批准号: 7376212
• 负责人: TOBEY J. MACDONALD
• 金额: $ 0.31万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376212
• 关键词: PBTC016; PHASE; MOLECULAR; BIOLOGY; II

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. This is a Phase I trial to estimate the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of CLORETAZINE¿ (VNP40101M) administered intravenously daily for 5 consecutive days every six weeks to children with recurrent, progressive or refractory primary brain tumors. The MTD will be estimated in two strata: a) Stratum 1: Patients who received no prior XRT or focal XRT only and/or 2 prior myelosuppressive chemotherapy or biological therapy regimens. Primary Objective: 1. To estimate the MTD and describe the DLT of CLORETAZINE¿ (VNP40101M) when administered intravenously daily for 5 days every 6 weeks to children with recurrent, progressive or refractory primary brain tumors. Secondary Objectives: 1. To characterize the pharmacokinetics of CLORETAZINE¿ (VNP40101M), and its active metabolite VNP4090CE, in children with recurrent, progressive or refractory primary brain tumors. 2. To estimate depletion of alkyl guanine alkyltransferase (AGT) in peripheral blood mononuclear cells (PBMC) in children with recurrent, progressive or refractory primary brain after exposure to CLORETAZINE¿ (VNP40101M). 3. To obtain preliminary evidence of efficacy of CLORETAZINE¿ (VNP40101M) in children with recurrent, progressive or refractory primary brain tumors.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一，该子项目和研究者 (PI) 可能已从其他 NIH 来源获得主要资助，因此可以在其他 CRISP 机构中得到体现。列出的是中心，不一定是研究者的机构。这是一项 I 期试验，旨在估计氯雷他嗪的最大耐受剂量 (MTD) 和剂量限制毒性 (DLT)。 (VNP40101M) 每天静脉注射一次，每六周连续 5 天对患有复发性、进行性或难治性原发性脑肿瘤的儿童进行 MTD 评估：a) 层 1：既往未接受过 XRT 或仅接受过局灶性 XRT 的患者； / 或 2 种既往骨髓抑制化疗或生物治疗方案 主要目标： 1. 估计 MTD 并描述氯雷他嗪的 DLT。 (VNP40101M) 对于患有复发性、进行性或难治性原发性脑肿瘤的儿童，每天静脉注射给药，每 6 周给药 5 天。 次要目标： 1. 表征氯雷他嗪的药代动力学。 (VNP40101M) 及其活性代谢物 VNP4090CE，用于患有复发性、进行性或难治性原发性脑肿瘤的儿童 2. 评估患有复发性、进行性或难治性儿童的外周血单核细胞 (PBMC) 中烷基鸟嘌呤烷基转移酶 (AGT) 的消耗。接触氯雷他嗪后的初级大脑¿ (VNP40101M) 3. 获得氯雷他嗪功效的初步证据¿ (VNP40101M) 用于患有复发性、进行性或难治性原发性脑肿瘤的儿童。