A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer
The purpose of the trial is first to evaluate the safety of the combination of OSI-906 and
sorafenib in patients with 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 patietns) 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 wil
be taken off trial.
The trial willl collect blood samples to evalute the level of the investigaitonal agent in
the blood. Also samples of the patients tumor will be analyzed to evalute for markers that
may predict who benefits from treatment.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of MRI/CT Scans to Pre-treatment Scan
Efficacy will be measured by evaluating the number of patients who do not have disease progression (measured by CT or MRI scan) 5 months after starting treatment. Assessment of the endpoint of disease progression will be performed every 2 months using either CT or MRI scan. Participants will remain on the study until either evidence of disease progression or unacceptable side effects develop. This period is expected to be on the average 6 months long.
Bassel El-Rayes, MD
Emory University Winship Cancer Institute
United States: Institutional Review Board
|University of Michigan||Ann Arbor, Michigan 48109-0624|
|Ohio State University||Columbus, Ohio 43210|
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|