Solid TumorsPhase 1/2NCT02265510

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

A Phase 1/2 study testing INCB052793, gemcitabine and nab-paclitaxel in people with Solid Tumors and Advanced Malignancies, run by Incyte Corporation at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors, Advanced Malignancies, Metastatic Cancer
What is being tested?: INCB052793, gemcitabine and nab-paclitaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 14 sitesUnited States
Study dates: 10 Sep 2014to 27 Feb 2019
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 22Show fewer

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)

Who cannot join

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

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Study site
Atlanta, Georgia
Study site
Birmingham, Alabama
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Durham, North Carolina
Study site
Greenville, South Carolina
Study site
Hackensack, New Jersey
Study site
Indianapolis, Indiana
Site 2
Nashville, Tennessee
Study site
Nashville, Tennessee
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Portland, Oregon
Study site
West Hollywood, California

Other trials in United States

About this study

Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies

Conditions: Solid Tumors, Advanced Malignancies, Metastatic Cancer
Being tested: INCB052793, gemcitabine, nab-paclitaxel, dexamethasone, Carfilzomib
Medical subject headings: Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INCB052793Drug
Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
gemcitabineDrug
Also called Gemzar®
Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.
nab-paclitaxelDrug
Also called Abraxane®
nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
dexamethasoneDrug
Dexamethasone administered orally at the protocol-specified dose and frequency.
CarfilzomibDrug
Also called Kyprolis®
Carfilzomib administered intravenously at the protocol-specified dose and frequency.
bortezomibDrug
Also called Velcade®
Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
lenalidomideDrug
Also called Revlimid®
Lenalidomide administered orally at the protocol-specified dose and frequency.
azacitidineDrug
Also called Vidaza®
Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
INCB052793Drug
INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
pomalidomideDrug
Also called Pomalyst®
Pomalidomide administered orally at the protocol-specified dose and frequency.
INCB050465Drug
INCB050465 tablets administered orally at the protocol specified dose strength and frequency.
INCB039110Drug
Also called itacitinib
INCB039110 tablets administered orally at the protocol specified dose strength and frequency.

Study groups in NCT02265510
Study group	Role	What they receive
Phase 1a: INCB052793 Monotherapy	Experimental	Not described Receives: Drug: INCB052793
Phase 1b: INCB052793 Combination Therapy	Experimental	Not described Receives: Drug: gemcitabine; Drug: nab-paclitaxel; Drug: dexamethasone; Drug: Carfilzomib; Drug: bortezomib; Drug: lenalidomide; Drug: azacitidine; Drug: INCB052793; Drug: pomalidomide; Drug: INCB050465
Phase 2: INCB052793 and itacitinib Combination Therapy	Experimental	Not described Receives: Drug: azacitidine; Drug: INCB052793; Drug: INCB039110

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)
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.
Measured: Baseline through end of study (Up to approximately 4.5 years)

Secondary outcomes (21)

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.
Measured: Baseline through end of study (Up to approximately 4.5 years)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Cycle 2, Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 201427 Feb 2019

First posted16 Oct 2014 (estimated)
Study start10 Sep 2014
Primary completion27 Feb 2019
Study completion27 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Solid TumorsStudies of the same condition, open and under way.
More trials run by Incyte CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02265510
Sponsor's protocol ID: INCB 52793-101
Status last verified: Apr 2020
First submitted: 29 Sep 2014
Last updated: 17 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Expanded access: Available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies
ClinicalTrials.gov ID: NCT02265510
Acronym / sponsor ID: INCB 52793-101
Conditions: Solid Tumors, Advanced Malignancies, Metastatic Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 83 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: 10 Sep 2014 (actual)
Primary completion: 27 Feb 2019 (actual)
Study completion: 27 Feb 2019 (actual)
First posted: 16 Oct 2014 (estimated)
Results: Posted 17 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Phase 1a: INCB052793 Monotherapy	Experimental	Drug: INCB052793
Phase 1b: INCB052793 Combination Therapy	Experimental	Drug: gemcitabine, Drug: nab-paclitaxel, Drug: dexamethasone, Drug: Carfilzomib, Drug: bortezomib, Drug: lenalidomide, Drug: azacitidine, Drug: INCB052793, Drug: pomalidomide, Drug: INCB050465
Phase 2: INCB052793 and itacitinib Combination Therapy	Experimental	Drug: azacitidine, Drug: INCB052793, Drug: INCB039110

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INCB052793Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.	Drug	Phase 1a: INCB052793 Monotherapy
gemcitabineAlso: Gemzar®Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.	Drug	Phase 1b: INCB052793 Combination Therapy
nab-paclitaxelAlso: Abraxane®nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.	Drug	Phase 1b: INCB052793 Combination Therapy
dexamethasoneDexamethasone administered orally at the protocol-specified dose and frequency.	Drug	Phase 1b: INCB052793 Combination Therapy
CarfilzomibAlso: Kyprolis®Carfilzomib administered intravenously at the protocol-specified dose and frequency.	Drug	Phase 1b: INCB052793 Combination Therapy
bortezomibAlso: Velcade®Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.	Drug	Phase 1b: INCB052793 Combination Therapy
lenalidomideAlso: Revlimid®Lenalidomide administered orally at the protocol-specified dose and frequency.	Drug	Phase 1b: INCB052793 Combination Therapy
azacitidineAlso: Vidaza®Azacitidine administered subcutaneously at the protocol-specified dose and frequency.	Drug	Phase 1b: INCB052793 Combination Therapy, Phase 2: INCB052793 and itacitinib Combination Therapy
INCB052793INCB052793 tablets administered orally at the protocol specified dose strength and frequency.	Drug	Phase 1b: INCB052793 Combination Therapy, Phase 2: INCB052793 and itacitinib Combination Therapy
pomalidomideAlso: Pomalyst®Pomalidomide administered orally at the protocol-specified dose and frequency.	Drug	Phase 1b: INCB052793 Combination Therapy
INCB050465INCB050465 tablets administered orally at the protocol specified dose strength and frequency.	Drug	Phase 1b: INCB052793 Combination Therapy
INCB039110Also: itacitinibINCB039110 tablets administered orally at the protocol specified dose strength and frequency.	Drug	Phase 2: INCB052793 and itacitinib Combination Therapy

Primary outcome

Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Time frame: 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
Time frame: 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.

21 secondary outcomes

Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment
Time frame: Baseline through end of study (Up to approximately 4.5 years)
Phase 2: Number of Participants With at Least One TEAE and SAE
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
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
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
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
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
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
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
Time frame: Cycle 1, Day 1
Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
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
Time frame: Cycle 1, Day 1
Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Time frame: Cycle 1, Day 15
Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval
Time frame: Cycle 1, Day 15
Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
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
Time frame: Cycle 1, Day 15
Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
Time frame: Cycle 1, Day 15
Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Time frame: Cycle 2, Day 1
Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval
Time frame: Cycle 2, Day 1
Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
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
Time frame: Cycle 2, Day 1
Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
Time frame: Cycle 2, Day 1

Results and safety

Results posted to the registry on 17 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1a TGA - INCB052793 15 mg	3	0
Phase 1a TGA - INCB052793 25 mg	3	0
Phase 1a TGA - INCB052793 35 mg	6	0
Phase 1a TGA - INCB052793 50 mg	4	0
Phase 1a TGA - INCB052793 75 mg	3	0
Phase 1a TGA - INCB052793 100 mg	6	0
Phase 1a TGB - INCB052793 25 mg	3	0
Phase 1a TGB - INCB052793 35 mg	4	0
Phase 1a TGB - INCB052793 50 mg	4	0
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg	7	0
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2	5	0
Hase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2	16	0
Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2	9	0
Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2	10	0

Primary outcome: Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

Time frame: From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years). Count of participants. Unit: Participants

Measure	Phase 1a TGA - INCB052793 15 mg n = 3	Phase 1a TGA - INCB052793 25 mg n = 3	Phase 1a TGA - INCB052793 35 mg n = 6	Phase 1a TGA - INCB052793 50 mg n = 4	Phase 1a TGA - INCB052793 75 mg n = 3	Phase 1a TGA - INCB052793 100 mg n = 6	Phase 1a TGB - INCB052793 25 mg n = 3	Phase 1a TGB - INCB052793 35 mg n = 4	Phase 1a TGB - INCB052793 50 mg n = 4	Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg n = 7	Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 n = 5	Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 n = 16
TEAE	3	3	6	4	3	6	3	4	4	7	5	16
SAE	0	1	0	2	3	2	1	2	2	5	4	14

Population analysed: Safety evaluable population included all participants exposed to ≥ 1 dose of study drug.

Primary outcome: Phase 2: Objective Response Rate (ORR) in Hematological Malignancies

Time frame: Baseline through end of study (Up to approximately 4.5 years). Count of participants. Unit: Participants

Measure	Phase 2 Cohort I-INCB052793 +Azacytidine (AML) n = 6	Phase 2 Cohort I-INCB052793 +Azacytidine (MDS) n = 3	Phase 2 Cohort J-Itacitinib +Azacitidine (AML) n = 8	Phase 2 Cohort J-Itacitinib +Azacitidine (MDS) n = 2
Value	0	1	1	0

Population analysed: Efficacy evaluable population included all participants exposed to ≥ 1 dose of study drug.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1a TGA - INCB052793 15 mg	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Phase 1a TGA - INCB052793 25 mg	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Phase 1a TGA - INCB052793 35 mg	0 of 6 (0%)	6 of 6 (100%)	2 of 6
Phase 1a TGA - INCB052793 50 mg	2 of 4 (50%)	4 of 4 (100%)	2 of 4
Phase 1a TGA - INCB052793 75 mg	3 of 3 (100%)	3 of 3 (100%)	1 of 3
Phase 1a TGA - INCB052793 100 mg	2 of 6 (33.3%)	6 of 6 (100%)	3 of 6
Phase 1a TGB - INCB052793 25 mg	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Phase 1a TGB - INCB052793 35 mg	2 of 4 (50%)	4 of 4 (100%)	1 of 4
Phase 1a TGB - INCB052793 50 mg	2 of 4 (50%)	4 of 4 (100%)	3 of 4
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg	5 of 7 (71.4%)	7 of 7 (100%)	3 of 7
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2	4 of 5 (80%)	5 of 5 (100%)	4 of 5
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2	14 of 16 (87.5%)	16 of 16 (100%)	12 of 16
Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2	7 of 9 (77.8%)	9 of 9 (100%)	7 of 9
Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2	8 of 10 (80%)	10 of 10 (100%)	6 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ekaterine Asatiani, M.D. study director

Incyte Corporation

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing INCB052793, gemcitabine and nab-paclitaxel in people with Solid Tumors and Advanced Malignancies, run by Incyte Corporation at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) (time frame: From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02265510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.