A Phase 1b/2, Open-label, Randomized Study of MEDI-573 in Combination With Sorafenib Verses Sorafenib Alone in Adult Subjects With Unresectable or Metastatic Hepatocellular Carcinoma
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase Ib: (Dose Evaluation Phase): Safety and Tolerability of 2 Dose Levels of MEDI-573 Combined with Standard of Care (SOC)
The primary objective of the dose-evaluation phase of this study (Phase 1b) is to evaluate the safety and tolerability of MEDI-573 in combination with SOC in subjects with unresectable or metastatic HCC. This will be measured by the number of adverse events, serious adverse events, and laboratory changes from baseline.
6 Months
Yes
Susan Perez, MD
Study Director
MedImmune LLC
United States: Food and Drug Administration
CD-ON-MEDI-573-1028
NCT01498952
January 2012
May 2013
Name | Location |
---|---|
Research Site | Anaheim, California |
Research Site | Boulder, Colorado |
Research Site | Las Vegas, Nevada |