Liver Cancer Clinical Trial
Official title:
A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer
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.
The purpose of the trial is first to evaluate the safety of the combination of OSI-906 and
sorafenib in patients with hepatocellular cancer (HCC). Patients will be treated in groups of
three with full dose sorafenib and OSI-906. If we do not observe any significant side
effects, then three additional patients will be treated at the same dose level. After
confirming the safety of the combination (possibly after first six patients) the study will
proceed with regular accrual. The patients will receive the treatments orally and will be
evaluated by physical exam, blood work and imaging. If the cancer is well controlled and the
therapy is well tolerated then patients will continue on the trial. If the side effects are
significant or the tumor starts to grow or the patients wishes to stop therapy the patient at
that time will be taken off trial.
The trial will collect blood samples to evaluate the level of the investigational agent in
the blood. Also samples of the patients tumor will be analyzed to evaluate for markers that
may predict who benefits from treatment.
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