An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies

Phase 2: Number of Participants With at Least One TEAE and SAE

An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.

Time frame: From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years)

Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793

Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.

Time frame: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793

Tmax is the time to maximum (peak) observed plasma drug concentration. Summary of Steady-State, Day 15, was evaluated by dosing regimen. For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.

Time frame: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793

AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.

Time frame: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration of Itacitinib

Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).

Time frame: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for Itacitinib

Tmax is the time to maximum (peak) observed plasma drug concentration.

Time frame: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib

AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).

Time frame: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793

Cmax is defined as the maximum observed plasma concentration measured at Day 1.

Time frame: Cycle 1, Day 1

Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793

Tmax is the time to maximum (peak) observed plasma drug concentration.

Time frame: Cycle 1, Day 1

Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time t

AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

Time frame: Cycle 1, Day 1

Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793

Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).

Time frame: Cycle 1, Day 15

Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval

Minimum observed plasma concentration measured at steady state (Day 15).

Time frame: Cycle 1, Day 15

Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793

Tmax is the time to maximum (peak) observed plasma drug concentration.

Time frame: Cycle 1, Day 15

Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time

AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).

Time frame: Cycle 1, Day 15

Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793

AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

Time frame: Cycle 1, Day 15

Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793

Cmax is defined as the maximum observed plasma concentration measured at cycle 2 Day 1.

Time frame: Cycle 2, Day 1

Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval

Cmin is defined as the minimal observed plasma concentration measured at cycle 2 Day 1

Time frame: Cycle 2, Day 1

Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793

Tmax is the time to maximum (peak) observed plasma drug concentration.

Time frame: Cycle 2, Day 1

Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time

AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

Time frame: Cycle 2, Day 1

Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793

AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

Time frame: Cycle 2, Day 1