A clinical study to evaluate 2 different test drugs combined with Sorafenib as the standard of care in the treatment of Liver cell cancer.

What we are studying

This research study is a Phase Ib/II clinical trial. Phase Ib clinical trials test the safety of investigational drugs in combination with approved anti-cancer drugs. Phase Ib studies also try to determine the appropriate dose of the investigational drug to use in combination with the approved anti-cancer drug in further studies. Phase II clinical trials test whether an investigational drug has a good chance to be effective in treating certain cancers. Phase II trials usually don’t give a definite answer about whether an investigational drug is effective, but usually do provide some clues. These clues can then be used to plan larger trials – which are designed to determine whether a drug “works” or not. This study will first have a Phase Ib part, followed by a Phase II part. The main goals of the Phase Ib part of this research study are to: o Find a dose of the study drug (either BBI608 or BBI503) that can be given in combination with sorafenib without causing severe side effects. o Determine the level of the study drug (either BBI608 or BBI503) and sorafenib in your bloodstream o Determine if the study drug (either BBI608 or BBI503) and sorafenib cause any change in you and your cancer. This study is not intended to evaluate whether the study drug (either BBI608 or BBI503) is more or less effective than is sorafenib alone in the treatment of liver cancer. The main goals of the Phase II part of this research study are to: o Confirm that the combination of sorafenib and BBI608 and the combination of sorafenib and BBI503 are tolerable and safe for patients with liver cancer o Determine if the study drug (either BBI608 or BBI503) and sorafenib cause any change in you and your cancer This study is not designed to definitively prove whether combining the study drug (either BBI608 or BBI503) with sorafenib is more or less effective than is sorafenib alone for the treatment of liver cancer. The study is designed, however, to provide some early clues about the effects of combining BBI608 with sorafenib or BBI503 with sorafenib, and to explore potential differences with the effects of using sorafenib alone.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • ECOG performance status < 1
  • Child-Pugh class A
  • Adequate renal function
  • And a life expectancy of greater than 3 months. Patients with known HIV infection are excluded. Can not be pregnant or breastfeeding
  • Can not have significant gastrointestinal disorder
  • Able to swallow capsules or tablets
  • Can not have abnormal ECGs which are clinically significant.

What is involved

  • Medical history/Physical exam
  • Blood draws
  • ECG
  • ECOG
  • Urinalysis
  • Tumor biopsy
  • CT/MRI Scan

Compensation

None.

Contact Information

Study Coordinator
Amy Neal, RN
Email
aneal@wakehealth.edu
Phone
336-713-6912
Principal Investigator
Dr. Rodwige J. Desnoyers

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.