The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Upmc Cancercenter
Pittsburgh, Pennsylvania, United States
Md Anderson Cancer Center
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Chris Obrien Lifehouse
Camperdown, New South Wales, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Cliniques Universitaires Ucl Saint-Luc
Brussels, Belgium
...and 11 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 INCB099280
Maximum observed plasma concentration
Time frame: Up to approximately 3 months
tmax of INCB099280
Time to maximum plasma concentration
Time frame: Up to approximately 3 months
Cmin of INCB099280
Minimum observed plasma concentration over the dose interval
Time frame: Up to approximately 3 months
AUC0-t of INCB099280
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 INCB099280
Apparent terminal-phase disposition half-life
Time frame: Up to approximately 3 months
λz of INCB099280
Terminal elimination rate constant
Time frame: Up to approximately 3 months
CL/F of INCB099280
Oral dose clearance
Time frame: Up to approximately 3 months
Vz/F of INCB099280
Apparent oral dose volume of distribution
Time frame: Up to approximately 3 months
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