CLINICAL TRIAL: A PHASE II STUDY OF AZD6244 IN ADVANCED OR METASTATIC HEPATOCELL

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 目的：确定单药AZD6244对肝细胞癌患者的客观有效率(完全缓解+部分缓解)。 研究对象：晚期或转移性肝细胞癌患者。 程序(方法)：将患者分为两组：中度肝功能障碍组和接近正常肝功能组。所有患者都将在治疗前进行活组织检查，然后单次注射研究试剂AZD6244，进行为期三天的药代动力学(PK)分析。接近正常(有效)的队列将在第7天接受额外的活检，然后继续服用 AZD6244口服，每天两次，直到病情进展，不可接受的毒性或停药。中度肝功能障碍(安全)队列将在21天的周期后进行评估，以进行必要的剂量减少，然后继续进行，直到病情恶化、不可接受的毒性或停药。

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. Purpose: To ascertain the objective response rate (complete response plus partial response) of single agent AZD6244 in patients with hepatocellular carcinoma. Participants: Patients with advanced or metastatic hepatocellular carcinoma. Procedures (methods): Patients will be divided into two groups: moderate liver dysfunction and near normal liver function cohorts. All patients will have pre-treatment biopsies, followed by a single administration of study agent, AZD6244, for three days of pharmacokinetic (PK) analysis. The near normal (Efficacy) cohort will undergo an additional biopsy at Day 7, and then continue taking AZD6244 orally, twice daily until progression, unacceptable toxicity or withdrawal. The moderate liver dysfunction (Safety) cohort will be evaluated after a 21 day cycle for necessary dose reductions and then continue until progression, unacceptable toxicity or withdrawal.