A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer
Status:
Terminated
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the effect of combining a new investigational drug
(OSI-906) with a standard drug (sorafenib) on the control of liver cancer (hepatocellular
cancer). Sorafenib (brand name Nexavar®) is a drug that is approved for the treatment of
advanced liver cancer. It works by stopping the growth of new blood vessels around the tumor.
OSI-906 is an investigational agent that works by inhibiting the effects of a growth hormone
on the cancer. The safety and efficacy of combining OSI-906 and sorafenib in the treatment of
liver cancer risk not known. The current study will confirm the safety of the combination in
the first six patients and evaluate the activity of the combination in patients with advanced
liver cancer.
In addition, the study will aim at collecting blood samples from patients to evaluate the
level of OSI-906 in patients receiving the combination of the two drugs. The study also will
collect samples of the tumor to evaluate for markers that can predict in which patient the
combination is effective.