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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 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。 目的：确定AZD 6244单药治疗肝细胞癌患者的客观缓解率（完全缓解加部分缓解）。 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：中度肝功能障碍和接近正常肝功能队列。所有患者将接受治疗前活检，随后接受研究药物AZD 6244单次给药，进行为期3天的药代动力学（PK）分析。接近正常（疗效）队列将在第7天接受额外的活检，然后继续服用 AZD 6244口服，每日两次，直至疾病进展、不可接受的毒性或停药。中度肝功能障碍（安全性）队列将在21天周期后评估必要的剂量降低，然后继续直至进展、不可接受的毒性或退出。

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.