Randomized Phase I/II of RAD001 in Advanced Hepatocellular Carcinoma (HCC)
Status:
Unknown status
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
The mTOR has been examined in hepatocellular carcinomas as well. This pathway is up-regulated
in a proportion of hepatocellular carcinoma (HCC) and that rapamycin inhibits cell
proliferation and blocks S6K phosphorylation. Inhibition of mTOR had been shown to suppress
substantially the liver tumor growth. Nevertheless, inhibition of mTOR was demonstrated to
have a clinical response in some cancer types. These reports imply that inhibition of mTOR
could be a promising therapeutic strategy in the treatment of HCC. Therefore, we hypothesize
that RAD001, a rapamycin analog, can inhibit the mTOR, and subsequently suppress the liver
tumor in the treatment of HCC patients.
This study is aimed to investigate the safety, efficacy, pharmacokinetics, pharmacogenetics
and feasibility of RAD001 in advanced HCC patients. This study will be a randomized phase I
study with dose escalation and subsequently a phase II study of intent to treat, as well as
pharmacokinetic, pharmacogenetic and surrogate marker study of RAD001.