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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02265510
Other study ID # INCB 52793-101
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date September 10, 2014
Est. completion date February 27, 2019

Study information

Verified date April 2020
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 83
Est. completion date February 27, 2019
Est. primary completion date February 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 PI3Kd 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

Study Design


Intervention

Drug:
INCB052793
Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
gemcitabine
Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.
nab-paclitaxel
nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
dexamethasone
Dexamethasone administered orally at the protocol-specified dose and frequency.
Carfilzomib
Carfilzomib administered intravenously at the protocol-specified dose and frequency.
bortezomib
Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
lenalidomide
Lenalidomide administered orally at the protocol-specified dose and frequency.
azacitidine
Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
INCB052793
INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
pomalidomide
Pomalidomide administered orally at the protocol-specified dose and frequency.
INCB050465
INCB050465 tablets administered orally at the protocol specified dose strength and frequency.
INCB039110
INCB039110 tablets administered orally at the protocol specified dose strength and frequency.

Locations

Country Name City State
United States Site 2 Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)
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. Baseline through end of study (Up to approximately 4.5 years)
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. Baseline through end of study (Up to approximately 4.5 years)
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. From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years)
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. 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
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. 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
Secondary Phase 1a, 1b, and Phase 2: AUC0-t: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 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). 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. 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
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). 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
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. 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
Secondary Phase 1a, 1b, and Phase 2: AUC0-t: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib 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). 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
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. Cycle 1, Day 1
Secondary Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 Tmax is the time to maximum (peak) observed plasma drug concentration. Cycle 1, Day 1
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. Cycle 1, Day 1
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). Cycle 1, Day 15
Secondary Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval Minimum observed plasma concentration measured at steady state (Day 15). Cycle 1, Day 15
Secondary Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 Tmax is the time to maximum (peak) observed plasma drug concentration. Cycle 1, Day 15
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). Cycle 1, Day 15
Secondary Phase 1a, Part 2: AUC0-t: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Cycle 1, Day 15
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. Cycle 2, Day 1
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 Cycle 2, Day 1
Secondary Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 Tmax is the time to maximum (peak) observed plasma drug concentration. Cycle 2, Day 1
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. Cycle 2, Day 1
Secondary Phase 1a, Part 2: AUC0-t: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Cycle 2, Day 1
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