Advanced Malignancies, Metastatic Cancer, Solid Tumors
Conditions
Brief summary
This was a study of INCB052793 given to patients with advanced malignancies that was to be conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine). Phase 1 had two parts; a dose escalation (Part 1) and an expansion (Part 2).
Interventions
DRUGINCB052793
Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
DRUGgemcitabine
Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.
DRUGnab-paclitaxel
nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
DRUGdexamethasone
Dexamethasone administered orally at the protocol-specified dose and frequency.
DRUGCarfilzomib
Carfilzomib administered intravenously at the protocol-specified dose and frequency.
DRUGbortezomib
Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
DRUGlenalidomide
Lenalidomide administered orally at the protocol-specified dose and frequency.
DRUGazacitidine
Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
DRUGpomalidomide
Pomalidomide administered orally at the protocol-specified dose and frequency.
DRUGINCB050465
INCB050465 tablets administered orally at the protocol specified dose strength and frequency.
DRUGINCB039110
INCB039110 tablets administered orally at the protocol specified dose strength and frequency.
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase 1a * Aged 18 years or older * Histologically or cytologically confirmed solid tumor or hematologic malignancy * Life expectancy of 12 weeks or longer * Must have received ≥ 1 prior treatment regimen * Must not be a candidate for potentially curative or standard of care approved therapy Phase 1b * Aged 18 years or older * Cohort A: Histologically or cytologically confirmed pancreatic adenocarcinoma, triple-negative breast cancer, urothelial cancer with at least 1 measurable or evaluable target lesion * Cohorts B, C, D, E and G: Histologically confirmed multiple myeloma and measureable/evaluable disease * Cohort F: Confirmed acute myeloid leukemia or myelodysplastic syndrome * Cohort H: Individuals diagnosed with lymphoma * Prior therapy: * Cohort A: No more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy) * Cohorts B, C, D, E and G: Must have relapsed from or have been refractory to ≥ 2 prior treatment regimens * Cohort F: May have received any number of prior treatment regimens or be treatment-naïve * Cohort H: Must have relapsed from or have been refractory to available treatments Phase 2 * Aged 18 years or older * Cohorts I and J: Confirmed acute myeloid leukemia or high risk myelodysplastic syndrome * Prior therapy: * Cohorts I and J: Must have failed prior therapy with a hypomethylating agent (HMA)
Exclusion criteria
* Prior receipt of a JAK1 inhibitor (Phase 1a only) * Known active central nervous system metastases and/or carcinomatous meningitis * Eastern Cooperative Oncology Group (ECOG) performance status \> 2 * Any known contraindications to the use of gemcitabine, nab-paclitaxel, dexamethasone, carfilzomib, bortezomib, lenalidomide, azacitidine, pomalidomide or PI3Kδ inhibitor (Phase 1b and Phase 2 only, as appropriate to treatment cohort) * Known human immunodeficiency virus infection, or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years) | 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. |
| Phase 2: Objective Response Rate (ORR) in Hematological Malignancies | Baseline through end of study (Up to approximately 4.5 years) | ORR is defined as the proportion of participants who achieved complete response (CR), CR with incomplete hematologic recovery (CRi), partial response (PR), or hematologic improvement (HI), using the IWG response criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 | 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 | 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. |
| Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 | 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 | 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. |
| Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 | 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 | 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. |
| Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration of Itacitinib | 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 | Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15). |
| Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for Itacitinib | 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 | Tmax is the time to maximum (peak) observed plasma drug concentration. |
| Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib | 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 | 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). |
| Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment | Baseline through end of study (Up to approximately 4.5 years) | Response rate is defined as the percentage of participants who achieved best overall response (BOR) as determined by IWG response criteria of investigator's assessment. A participant was considered an objective responder based on the following- Solid tumors: participant had a best overall response (BOR) of CR or PR, Lymphoma: participant had a BOR of complete radiologic response/complete metabolic response or partial remission/partial metabolic response, AML: participant had a BOR of CR, CRi, morphological leukemia-free state (MLFS), or PR, MDS: participant had a BOR of CR, PR, or marrow CR, MDS/myeloproliferative neoplasm (MPN): participant had a BOR of CR, PR, or marrow response, MM: participant had a BOR of stringent CR, CR, very good PR, PR, or MR. Subjects are combined by tumor type for this analysis. |
| Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 | Cycle 1, Day 1 | Tmax is the time to maximum (peak) observed plasma drug concentration. |
| 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 | Cycle 1, Day 1 | AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. |
| Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval | Cycle 1, Day 15 | Minimum observed plasma concentration measured at steady state (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 | Cycle 1, Day 15 | 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). |
| Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 | Cycle 1, Day 15 | AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. |
| Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 | Cycle 1, Day 1 | Cmax is defined as the maximum observed plasma concentration measured at Day 1. |
| Phase 2: Number of Participants With at Least One TEAE and SAE | From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 11 investigative sites in United States from 10 September 2014 to 27 February 2019. This study was prematurely terminated due to lack of efficacy.
Pre-assignment details
Participants with advanced malignancies,acute myeloid leukemia(AML),high-risk myelodysplastic syndrome(MDS)who failed prior therapy with hypomethylating agents(HMA)enrolled to dose escalation(Part 1),expansion(Part 2) of INCB052793 monotherapy and combination therapy cohorts.CohortsA,C,D,E,G,H had no enrollment at the time of premature termination.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1a TGA - INCB052793 15 mg INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. | 3 |
| Phase 1a TGA - INCB052793 25 mg INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. | 3 |
| Phase 1a TGA - INCB052793 35 mg INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria | 6 |
| Phase 1a TGA - INCB052793 50 mg INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. | 4 |
| Phase 1a TGA - INCB052793 75 mg INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. | 3 |
| Phase 1a TGA - INCB052793 100 mg INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. | 6 |
| Phase 1a TGB - INCB052793 25 mg INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria. | 3 |
| Phase 1a TGB - INCB052793 35 mg INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria. | 4 |
| Phase 1a TGB - INCB052793 50 mg INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria. | 4 |
| Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle. | 7 |
| Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle. | 5 |
| Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle | 16 |
| Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2 INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle | 9 |
| • Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2 Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle | 10 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 2 | 0 | 2 | 2 | 1 | 3 | 2 | 1 | 3 | 3 | 4 | 12 | 7 | 6 |
| Overall Study | Disease Progression | 0 | 1 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 |
| Overall Study | Other | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Study Terminated by Sponsor | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 2 | 1 | 4 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 2 | 1 | 0 | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Phase 1a TGA - INCB052793 15 mg | Phase 1a TGA - INCB052793 25 mg | Phase 1a TGA - INCB052793 35 mg | Phase 1a TGA - INCB052793 50 mg | Phase 1a TGA - INCB052793 75 mg | Phase 1a TGA - INCB052793 100 mg | Phase 1a TGB - INCB052793 25 mg | Phase 1a TGB - INCB052793 35 mg | Phase 1a TGB - INCB052793 50 mg | Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg | Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 | Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 | Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2 | • Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 8.08 | 59.0 years STANDARD_DEVIATION 9.85 | 57.0 years STANDARD_DEVIATION 13.19 | 54.5 years STANDARD_DEVIATION 13.4 | 46.0 years STANDARD_DEVIATION 15.13 | 63.0 years STANDARD_DEVIATION 10.77 | 60.3 years STANDARD_DEVIATION 6.66 | 58.5 years STANDARD_DEVIATION 6.45 | 56.3 years STANDARD_DEVIATION 3.69 | 60.3 years STANDARD_DEVIATION 13.84 | 62.8 years STANDARD_DEVIATION 14.17 | 64.4 years STANDARD_DEVIATION 15.47 | 70.4 years STANDARD_DEVIATION 5.64 | 71.2 years STANDARD_DEVIATION 8.5 | 62.6 years STANDARD_DEVIATION 12.31 |
| Race/Ethnicity, Customized American-Indian/Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/African-American | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 2 Participants | 3 Participants | 6 Participants | 4 Participants | 2 Participants | 6 Participants | 2 Participants | 3 Participants | 4 Participants | 6 Participants | 5 Participants | 16 Participants | 9 Participants | 10 Participants | 78 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White/Caucasian | 3 Participants | 3 Participants | 5 Participants | 2 Participants | 2 Participants | 5 Participants | 2 Participants | 3 Participants | 4 Participants | 5 Participants | 5 Participants | 14 Participants | 9 Participants | 8 Participants | 70 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 7 Participants | 2 Participants | 2 Participants | 29 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 4 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 4 Participants | 3 Participants | 7 Participants | 2 Participants | 9 Participants | 7 Participants | 8 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 3 | 0 / 3 | 2 / 6 | 2 / 4 | 1 / 3 | 3 / 6 | 2 / 3 | 1 / 4 | 3 / 4 | 3 / 7 | 4 / 5 | 12 / 16 | 7 / 9 | 6 / 10 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 6 / 6 | 4 / 4 | 3 / 3 | 6 / 6 | 3 / 3 | 4 / 4 | 4 / 4 | 7 / 7 | 5 / 5 | 16 / 16 | 9 / 9 | 10 / 10 |
| serious Total, serious adverse events | 0 / 3 | 1 / 3 | 0 / 6 | 2 / 4 | 3 / 3 | 2 / 6 | 1 / 3 | 2 / 4 | 2 / 4 | 5 / 7 | 4 / 5 | 14 / 16 | 7 / 9 | 8 / 10 |
Outcome results
Primary
Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (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 3.4 years)
Population: Safety evaluable population included all participants exposed to ≥ 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1a TGA - INCB052793 15 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 3 Participants |
| Phase 1a TGA - INCB052793 15 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 Participants |
| Phase 1a TGA - INCB052793 25 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 3 Participants |
| Phase 1a TGA - INCB052793 25 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 1 Participants |
| Phase 1a TGA - INCB052793 35 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 6 Participants |
| Phase 1a TGA - INCB052793 35 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 Participants |
| Phase 1a TGA - INCB052793 50 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 4 Participants |
| Phase 1a TGA - INCB052793 50 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 2 Participants |
| Phase 1a TGA - INCB052793 75 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 3 Participants |
| Phase 1a TGA - INCB052793 75 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 3 Participants |
| Phase 1a TGA - INCB052793 100 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 6 Participants |
| Phase 1a TGA - INCB052793 100 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 2 Participants |
| Phase 1a TGB - INCB052793 25 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 1 Participants |
| Phase 1a TGB - INCB052793 25 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 3 Participants |
| Phase 1a TGB - INCB052793 35 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 4 Participants |
| Phase 1a TGB - INCB052793 35 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 2 Participants |
| Phase 1a TGB - INCB052793 50 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 4 Participants |
| Phase 1a TGB - INCB052793 50 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 2 Participants |
| Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 7 Participants |
| Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 5 Participants |
| Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 4 Participants |
| Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 5 Participants |
| Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 14 Participants |
| Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 | Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 16 Participants |
Primary
Phase 2: Objective Response Rate (ORR) in Hematological Malignancies
ORR is defined as the proportion of participants who achieved complete response (CR), CR with incomplete hematologic recovery (CRi), partial response (PR), or hematologic improvement (HI), using the IWG response criteria.
Time frame: Baseline through end of study (Up to approximately 4.5 years)
Population: Efficacy evaluable population included all participants exposed to ≥ 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1a TGA - INCB052793 15 mg | Phase 2: Objective Response Rate (ORR) in Hematological Malignancies | 0 Participants |
| Phase 1a TGA - INCB052793 25 mg | Phase 2: Objective Response Rate (ORR) in Hematological Malignancies | 1 Participants |
| Phase 1a TGA - INCB052793 35 mg | Phase 2: Objective Response Rate (ORR) in Hematological Malignancies | 1 Participants |
| Phase 1a TGA - INCB052793 50 mg | Phase 2: Objective Response Rate (ORR) in Hematological Malignancies | 0 Participants |
Secondary
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
Population: The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a TGA - INCB052793 15 mg | Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 | 4750 nM*hr | Standard Deviation 1380 |
| Phase 1a TGA - INCB052793 25 mg | Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 | 9170 nM*hr | Standard Deviation 4290 |
| Phase 1a TGA - INCB052793 35 mg | Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 | 8430 nM*hr | Standard Deviation 2520 |
| Phase 1a TGA - INCB052793 50 mg | Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 | 14700 nM*hr | Standard Deviation 6670 |
| Phase 1a TGA - INCB052793 75 mg | Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 | 18300 nM*hr | Standard Deviation 10600 |
| Phase 1a TGA - INCB052793 100 mg | Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 | 27800 nM*hr | Standard Deviation 12300 |
| Phase 1a TGB - INCB052793 25 mg | Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 | 6390 nM*hr | Standard Deviation 1690 |
| Phase 1a TGB - INCB052793 35 mg | Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 | 9580 nM*hr | Standard Deviation 6710 |
| Phase 1a TGB - INCB052793 50 mg | Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 | 10200 nM*hr | Standard Deviation 5260 |
| Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg | Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 | 9380 nM*hr | Standard Deviation 4390 |
Secondary
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
Population: The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a TGA - INCB052793 15 mg | Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib | 9870 nM*hr | Standard Deviation 7350 |
Secondary
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
Population: The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a TGA - INCB052793 15 mg | Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 | 522 nM | Standard Deviation 126 |
| Phase 1a TGA - INCB052793 25 mg | Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 | 1110 nM | Standard Deviation 324 |
| Phase 1a TGA - INCB052793 35 mg | Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 | 1120 nM | Standard Deviation 543 |
| Phase 1a TGA - INCB052793 50 mg | Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 | 2050 nM | Standard Deviation 1070 |
| Phase 1a TGA - INCB052793 75 mg | Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 | 1840 nM | Standard Deviation 563 |
| Phase 1a TGA - INCB052793 100 mg | Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 | 2890 nM | Standard Deviation 1690 |
| Phase 1a TGB - INCB052793 25 mg | Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 | 928 nM | Standard Deviation 263 |
| Phase 1a TGB - INCB052793 35 mg | Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 | 1270 nM | Standard Deviation 856 |
| Phase 1a TGB - INCB052793 50 mg | Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 | 1480 nM | Standard Deviation 588 |
| Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg | Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 | 1610 nM | Standard Deviation 745 |
Secondary
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
Population: The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1a TGA - INCB052793 15 mg | Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration of Itacitinib | 1310 nM | Standard Deviation 638 |
Secondary
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
Population: The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1a TGA - INCB052793 15 mg | Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 | 1.1 hours (hr) |
| Phase 1a TGA - INCB052793 25 mg | Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 | 0.76 hours (hr) |
| Phase 1a TGA - INCB052793 35 mg | Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 | 2.0 hours (hr) |
| Phase 1a TGA - INCB052793 50 mg | Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 | 1.1 hours (hr) |
| Phase 1a TGA - INCB052793 75 mg | Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 | 2.2 hours (hr) |
| Phase 1a TGA - INCB052793 100 mg | Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 | 2.0 hours (hr) |
| Phase 1a TGB - INCB052793 25 mg | Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 | 1.0 hours (hr) |
| Phase 1a TGB - INCB052793 35 mg | Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 | 1.1 hours (hr) |
| Phase 1a TGB - INCB052793 50 mg | Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 | 1.1 hours (hr) |
| Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg | Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 | 0.51 hours (hr) |
Secondary
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
Population: The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1a TGA - INCB052793 15 mg | Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for Itacitinib | 3.5 hr |
Secondary
Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment
Response rate is defined as the percentage of participants who achieved best overall response (BOR) as determined by IWG response criteria of investigator's assessment. A participant was considered an objective responder based on the following- Solid tumors: participant had a best overall response (BOR) of CR or PR, Lymphoma: participant had a BOR of complete radiologic response/complete metabolic response or partial remission/partial metabolic response, AML: participant had a BOR of CR, CRi, morphological leukemia-free state (MLFS), or PR, MDS: participant had a BOR of CR, PR, or marrow CR, MDS/myeloproliferative neoplasm (MPN): participant had a BOR of CR, PR, or marrow response, MM: participant had a BOR of stringent CR, CR, very good PR, PR, or MR. Subjects are combined by tumor type for this analysis.
Time frame: Baseline through end of study (Up to approximately 4.5 years)
Population: Efficacy evaluable population included all participants exposed to ≥ 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1a TGA - INCB052793 15 mg | Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment | 0 Participants |
| Phase 1a TGA - INCB052793 25 mg | Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment | 0 Participants |
| Phase 1a TGA - INCB052793 35 mg | Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment | 1 Participants |
| Phase 1a TGA - INCB052793 50 mg | Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment | 0 Participants |
| Phase 1a TGA - INCB052793 75 mg | Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment | 2 Participants |
| Phase 1a TGA - INCB052793 100 mg | Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment | 4 Participants |
| Phase 1a TGB - INCB052793 25 mg | Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment | 3 Participants |
| Phase 1a TGB - INCB052793 35 mg | Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment | 2 Participants |
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study.
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study.
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study.
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study.
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study.
Secondary
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
Population: Data was not collected as no participants were enrolled in Part 2 of the study
Secondary
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)
Population: Safety evaluable population included all participants exposed to ≥ 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1a TGA - INCB052793 15 mg | Phase 2: Number of Participants With at Least One TEAE and SAE | TEAE | 9 Participants |
| Phase 1a TGA - INCB052793 15 mg | Phase 2: Number of Participants With at Least One TEAE and SAE | SAE | 7 Participants |
| Phase 1a TGA - INCB052793 25 mg | Phase 2: Number of Participants With at Least One TEAE and SAE | TEAE | 10 Participants |
| Phase 1a TGA - INCB052793 25 mg | Phase 2: Number of Participants With at Least One TEAE and SAE | SAE | 8 Participants |