RAD001 in Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title: A Phase I/II Study of RAD001 in Advanced Hepatocellular Carcinoma

Status Completed

Clinical Trial Summary

Laboratory studies have shown that RAD001 can prevent cells from multiplying. Consequently, the study drug is being tested in medical conditions in which excessive cell multiplication (as in cancer) needs to be stopped. The main purpose of this research study is to find the highest dose of RAD001 that can be given safely (without causing severe side effects) and to learn the effects (good or bad) RAD001 has on participants with liver cancer.

Clinical Trial Description

• Participants will be given a supply of the study drug RAD001 to be taken at home. They will be asked to take the study drug every morning on an empty stomach and will be given a study drug diary to record the time/date each time they take RAD001. Each 6 week period of time is called a cycle of study treatment.

• We are looking for the highest dose of RAD001 that can be given safely. Therefore not every participant will receive the same dose of RAD001.

• Participants will come to the clinic every other week. At each of these visits, a physical examination and blood tests will be performed.

• A CT and MRI will be repeated every 6 weeks during the first 3 cycles of treatment then every 12 weeks thereafter. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT00516165
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2007
• Completion date: November 2011