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

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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.