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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer|
- Comparison of MRI/CT Scans to Pre-treatment Scan [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Toxicity Assessment [ Time Frame: 28 days from study entry ] [ Designated as safety issue: Yes ]Evaluate the proportion of participants treated with OSI-906 and sorafenib who develop serious adverse events.
|Study Start Date:||March 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: Sorafenib and OSI-906
This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.
Drug: Sorafenib and OSI-906
Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily
Other Name: Nexavar
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334710
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Bassel El-Rayes, MD||Emory University Winship Cancer Institute|