Trial Information

Summary: A Phase II Open Label Study of Brivanib (BMS-582664), Administered Orally at a Dose of 800mg Daily in Subjects with Unsectable, Locally Advanced or Metastatic Hepatocellular Carcinoma Who Have Received Either No Prior Systemic Therapy or One Prior Regimen of Angiogenesis Inhibitor Therapy

You have been asked to participate in this research study because you have liver cancer that cannot be cured with surgery that has spread to the immediate area around the liver or to distant area(s) in your body.  The main purpose of this study is to compare BMS-582664 (an investigational drug) to doxorubicin (a standard chemotherapy for liver cancer) in terms of response (ability to shrink tumors or keep them from growing) and how long that response lasts.  Researchers would also like to find out what side effects are caused by BMS-582664 versus doxorubicin and the ability of subjects to tolerate them.  Researchers will also study tumor and blood specimens in the laboratory to find out whether biological and genetic differences in tumors are related to differences in response to treatment and to find out the effects of the different treatments on the cancer genes.  Lastly, researchers want to evaluate the impact of BMS-582665 versus doxorubicin on symptoms using a questionnaire.  Your treatment on this study is expected to last until you have an unacceptable side effect or your cancer worsens.  After you finish treatment, your medical condition will be followed indefinitely.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: July 7, 2008 at 2:40:09 PM