The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
INCB099318 administered orally in 20 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.
Hackensack University Medical Center
Hackensack, New Jersey, United States
Prisma Health Cancer Institute Faris
Greenville, South Carolina, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Universitair Ziekenhuis Brussel
Brussels, Belgium
Institut Jules Bordet
Brussels, Belgium
Universitair Ziekenhuis Antwerpen (Uza)
Edegem, Belgium
Ghent University Hospital
Ghent, Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, Belgium
Rigshospitalet Uni of Hospital of Copenhagen
Copenhagen, Denmark
Helsinki University Central Hospital
Helsinki, Finland
...and 14 more locations
Number of treatment-emergent adverse events
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 30 days after last dose of study drug.
Time frame: Up to approximately 25 months
Cmax of INCB099318
Maximum observed plasma concentration
Time frame: Up to approximately 3 months
tmax of INCB099318
Time to maximum plasma concentration
Time frame: Up to approximately 3 months
Cmin of INCB099318
Minimum observed plasma concentration over the dose interval
Time frame: Up to approximately 3 months
AUC0-t of INCB099318
Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t
Time frame: Up to approximately 3 months
t½ of INCB099318
Apparent terminal-phase disposition half-life
Time frame: Up to approximately 3 months
λz of INCB099318
Terminal elimination rate constant
Time frame: Up to approximately 3 months
CL/F of INCB099318
Oral dose clearance
Time frame: Up to approximately 3 months
Vz/F of INCB099318
Apparent oral dose volume of distribution
Time frame: Up to approximately 3 months
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