Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 1, one year; Part 2, one year
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Winship Cancer Institute||Atlanta, Georgia 30322|
|Moffitt Cancer Center||Tampa, Florida 33612|