The primary objectives of the study are to:~Evaluate the safety and tolerability of up to six months of treatment with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg TID by mouth) in subjects diagnosed with hepatocellular carcinoma that are either awaiting transplantation or have an unresectable lesion.~Evaluate the overall tumor response according to radiologic assessments of stable disease, complete response (CR), partial response (PR), or minor response (MR), as defined by Response Evaluation Criteria in Solid Tumors (RECIST), associated with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)~Evaluate the pharmacokinetic (PK) activity of clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)~The secondary objectives of the study are to:~• Evaluate the duration of response, time to progression, duration of stable disease (SD), and overall survival associated with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)
This study is a phase IIa open label pilot study of up to six months treatment with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 vs. 500 mg mg) given orally TID to subjects with hepatocellular carcinoma that are either awaiting transplantation or have an unresectable lesion.