Solid TumorsPhase 1/2NCT02587598

Study of INCB053914 in Subjects With Advanced Malignancies

A Phase 1/2 study testing INCB053914, I-DAC (Intermediate dose cytarabine) and Azacitidine in people with Solid Tumors, run by Incyte Corporation at 19 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors
What is being tested?: INCB053914, I-DAC (Intermediate dose cytarabine) and Azacitidine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 97 participants
Where: 19 sitesUnited States
Study dates: 29 Dec 2015to 11 Aug 2020
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

Aged 18 years or older
Confirmed diagnosis of select advanced malignancy
Parts 1 and 2:
Unresponsive to currently available therapy and there is no standard-of-care therapy available in the judgment of the investigator.
Not currently a candidate for curative treatment
Parts 3 and 4:

Show all 14Show fewer

Subjects with relapsed/refractory AML must have received either induction chemotherapy for AML or hypomethylating agents for hematologic disease before AML.
Elderly subjects (≥ 65 years) with newly diagnosed AML must be treatment naive and unfit for intensive chemotherapy.
Myelofibrosis subjects must have been treated with ruxolitinib for ≥ 6 months with a stable dose for ≥ 8 weeks (acceptable doses are 5 mg twice daily [BID] to 25 mg BID).
Willingness to undergo a pretreatment bone marrow biopsy and/or aspirate, or archival sample obtained since completion of most recent therapy (as appropriate to subjects with existing bone marrow disease or for whom bone marrow examination is a component of disease status assessment)
Eastern Cooperative Oncology Group (ECOG) performance status
Part 1: 0 or 1
Parts 2, 3 and 4: 0, 1, or 2
Life expectancy > 12 weeks or ≥ 24 weeks for Part 3 and Part 4 MF subjects.

Who cannot join

Inadequate bone marrow or organ function
Received an investigational agent within 5 half-lives or 14 days, whichever is longer, prior to receiving the first dose of study drug
Received non-biologic anticancer medication within 5 half-lives prior to receiving the first dose of study drug (within 6 weeks for mitomycin-C or nitrosoureas), within 28 days for any antibodies or biological therapies
Prior receipt of a PIM inhibitor
Any history of disease involving the central nervous system (Part 1). Known active disease involving the central nervous system (Part 2).
Screening corrected QT interval (QTc) interval > 470 milliseconds
Radiotherapy within the 2 weeks prior to initiation of treatment
Chronic or current active infection requiring systemic antibiotic, antifungal, or antiviral treatment

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Emory University-Winship Cancer Institute
Atlanta, Georgia, 30322
Texas Oncology
Austin, Texas, 78705
University of Maryland
Baltimore, Maryland, 21201
Dana-Farber Cancer Center
Boston, Massachusetts, 02215
Oncology Hematology Care Clinical Trials LLC
Cincinnati, Ohio, 45236
Mayo Clinic Florida
Jacksonville, Florida, 32224
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Tennessee Oncology
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06511
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 69198
UC Davis comprehensive Cancer Center
Sacramento, California, 95817
UCLA Medical Hematology & Oncology
Santa Monica, California, 90095
Florida Cancer Specialists & Research Institute
Sarasota, Florida, 33916
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
The University of Arizona Cancer Center
Tucson, Arizona, 85719
Texas Oncology
Tyler, Texas, 75702

Other trials in United States

About this study

Official title: A Phase 1/2 Study of INCB053914 in Subjects With Advanced Malignancies

This is an open-label, dose-escalation study of the proviral integration site of Moloney murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation) will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of INCB053914 in combination with select standard of care (SOC) agents and will identify the optimal INCB053914 dose in combination with conventional SOC regimens to take forward into Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and pharmacokinetics of the recommended Phase 2 dose combination(s).

Conditions: Solid Tumors
Being tested: INCB053914, I-DAC (Intermediate dose cytarabine), Azacitidine, Ruxolitinib
Keywords: leukemia, myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative neoplasms (MDS/MPN), myelofibrosis (MF), lymphoproliferative disorders, acute myeloid leukemia (AML), lymphomas, multiple myeloma (MM), PIM kinases
Medical subject headings: Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorders, Primary Myelofibrosis, Lymphoproliferative Disorders, Leukemia, Myeloid, Acute, Lymphoma, Multiple Myeloma

What participants receive

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

INCB053914Drug
Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria.
INCB053914 tablets to be administered by mouth.
I-DAC (Intermediate dose cytarabine)Drug
Cytarabine dose will be 1 g/m^2. Cytarabine will be administered as an intravenous (IV) infusion.
AzacitidineDrug
Also called Vidaza®
Azacitidine dose will be 75 mg/m^2. Azacitidine will be administered either sub-cutaneously (SC) or intravenously (IV).
RuxolitinibDrug
Starting dose of ruxolitinib will be the dose the subject was on at study entry Ruxolitinib will be administered by mouth.

Study groups in NCT02587598
Study group	Role	What they receive
Parts 1 and 2: INCB053914 100 mg QD	Experimental	INCB053914 will be self-administered orally once a day in as a 100mg immediate release tablet as a monotherapy. Receives: Drug: INCB053914
Parts 3 and 4: INCB053914 + Azacitidine	Experimental	Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914. Receives: Drug: INCB053914; Drug: Azacitidine
Parts 3 and 4: INCB053914 + I-DAC (Intermediate dose cytarabine)	Experimental	I-DAC (intermediate dose cytarabine) will be administered at a dose of 1 g/m2 per day as an infusion as a combination therapy with INCB053914. Receives: Drug: INCB053914; Drug: I-DAC (Intermediate dose cytarabine)
Parts 3 and 4: INCB053914 + Ruxolitinib	Experimental	Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914. Receives: Drug: INCB053914; Drug: Ruxolitinib
Parts 1 and 2: INCB053914 50 mg	Experimental	INCB053914 will be self-administered orally twice day in as a 50mg immediate release tablet as a monotherapy. Receives: Drug: INCB053914
Parts 1 and 2: INB053914 65 mg	Experimental	INCB053914 will be self-administered orally twice day in as a 65mg immediate release tablet as a monotherapy. Receives: Drug: INCB053914
Parts 1 and 2: INB053914 80 mg	Experimental	INCB053914 will be self-administered orally twice day in as a 80mg immediate release tablet as a monotherapy. Receives: Drug: INCB053914
Parts 1 and 2: INB053914 100 mg BID	Experimental	INCB053914 will be self-administered orally twice day in as a 100mg immediate release tablet as a monotherapy. Receives: Drug: INCB053914
Parts 1 and 2: INB053914 115 mg	Experimental	INCB053914 will be self-administered orally twice day in as a 115mg immediate release tablet as a monotherapy. Receives: Drug: INCB053914

What is being measured

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

Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events
Measured: Approximately 7 months
Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With the Intermediate-dose Cytarabine (I DAC) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) Based on Objective Remission Rate (ORR)
The primary efficacy endpoint of ORR in patients with AML who received INCB053914 in combination with cytarabine in Part 4 was not assessed because Part 4 was not opened for enrollment owing to this combination regimen not being tolerated in Part 3.
Measured: Approximately 2 months
Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With Azacitidine in Subjects With Newly Diagnosed AML Who Are 65 Years or Older and Unfit for Intensive Chemotherapy Based on ORR
The primary efficacy endpoint of ORR in patients with AML who received INCB053914 plus azacitidine in Part 4 was not performed due to limited enrollment as a result of early study termination.
Measured: Approximately 6 months

Secondary outcomes (21)

Evaluation of Phosphorylated BCL--2 Associated Death Promoter Protein (pBAD)
Percent Inhibition of pBAD at the C1D15 trough from the pBAD at pre-dose by ex vivo cellular assay
Measured: 1 month
Pharmacokinetics: Tmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Measured: Cycle 1 Day 5
Pharmacokinetics: AUCtau of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Measured: Cycle 1 Day 5
Pharmacokinetics: Cl/F of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Measured: Cycle 1 Day 5
Pharmacokinetics: Cmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Measured: Cycle 1 Day 5
Pharmacokinetics: Cmin of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Measured: Cycle 1 Day 5
Pharmacokinetics: Tmax of Combination Group B INCB053914 80 mg + Azatcitidine
Measured: Cycle 1 Day 8
Pharmacokinetics: AUCtau of Combination Group B INCB053914 80 mg + Azatcitidine
Measured: Cycle 1 Day 8
Pharmacokinetics: Cl/F of Combination Group B INCB053914 80 mg + Azatcitidine
Measured: Cycle 1 Day 8
Pharmacokinetics: Cmax of Combination Group B INCB053914 80 mg + Azatcitidine
Measured: Cycle 1 Day 8
Pharmacokinetics: Cmin of Combination Group B INCB053914 80 mg + Azatcitidine
Measured: Cycle 1 Day 8
Pharmacokinetics: Tmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Measured: Regimen 2 Week 4
Pharmacokinetics: AUCtau of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Measured: Regimen 2 Week 4
Pharmacokinetics: Cl/F of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Measured: Regimen 2 Week 4
Pharmacokinetics: Cmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Measured: Regimen 2 Week 4
Pharmacokinetics: Cmin of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Measured: Regimen 2 Week 4
Pharmacokinetics: Tmax of INCB053914 Monotherapy
Measured: Cycle 1 Day 8
Pharmacokinetics: AUCtau of INCB053914 Monotherapy
Measured: Cycle 1 Day 8
Pharmacokinetics: CL/F of INCB053914 Monotherapy
Measured: Cycle 1 Day 8
Pharmacokinetics: Cmax of INCB053914 Monotherapy
Measured: Cycle 1 Day 8
Pharmacokinetics: Ctau of INCB053914 Monotherapy
Measured: Cycle 1 Day 8

Timeline

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

29 Dec 201511 Aug 2020

First posted27 Oct 2015 (estimated)
Study start29 Dec 2015
Primary completion11 Aug 2020
Study completion11 Aug 2020

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.
Publications (1)Papers the sponsor has linked to this study.
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: Single group
Masking: None (open label)
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02587598
Sponsor's protocol ID: INCB 53914-101
Status last verified: Nov 2021
First submitted: 26 Oct 2015
Last updated: 8 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: No
Expanded access: Available

Publications

Patel MR, Donnellan W, Byrne M, Asch AS, Zeidan AM, Baer MR, Fathi AT, Kuykendall AT, Zheng F, Walker C, Cheng L, Marando C, Savona MR. Phase 1/2 Study of the Pan-PIM Kinase Inhibitor INCB053914 Alone or in Combination With Standard-of-Care Agents in Patients With Advanced Hematologic Malignancies. Clin Lymphoma Myeloma Leuk. 2023 Sep;23(9):674-686. doi: 10.1016/j.clml.2023.05.002. Epub 2023 May 15.
PubMed 37290996

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
Neoplasms
Active, not recruitingPhase 3
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
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Study of INCB053914 in Subjects With Advanced Malignancies
ClinicalTrials.gov ID: NCT02587598
Acronym / sponsor ID: INCB 53914-101
Conditions: Solid Tumors
Keywords: leukemia, myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative neoplasms (MDS/MPN), myelofibrosis (MF), lymphoproliferative disorders, acute myeloid leukemia (AML), lymphomas, multiple myeloma (MM)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 97 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: 29 Dec 2015 (actual)
Primary completion: 11 Aug 2020 (actual)
Study completion: 11 Aug 2020 (actual)
First posted: 27 Oct 2015 (estimated)
Results: Posted 8 Dec 2021

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: Single group
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Parts 1 and 2: INCB053914 100 mg QD	Experimental	Drug: INCB053914INCB053914 will be self-administered orally once a day in as a 100mg immediate release tablet as a monotherapy.
Parts 3 and 4: INCB053914 + Azacitidine	Experimental	Drug: INCB053914, Drug: AzacitidineAzacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
Parts 3 and 4: INCB053914 + I-DAC (Intermediate dose cytarabine)	Experimental	Drug: INCB053914, Drug: I-DAC (Intermediate dose cytarabine)I-DAC (intermediate dose cytarabine) will be administered at a dose of 1 g/m2 per day as an infusion as a combination therapy with INCB053914.
Parts 3 and 4: INCB053914 + Ruxolitinib	Experimental	Drug: INCB053914, Drug: RuxolitinibRuxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
Parts 1 and 2: INCB053914 50 mg	Experimental	Drug: INCB053914INCB053914 will be self-administered orally twice day in as a 50mg immediate release tablet as a monotherapy.
Parts 1 and 2: INB053914 65 mg	Experimental	Drug: INCB053914INCB053914 will be self-administered orally twice day in as a 65mg immediate release tablet as a monotherapy.
Parts 1 and 2: INB053914 80 mg	Experimental	Drug: INCB053914INCB053914 will be self-administered orally twice day in as a 80mg immediate release tablet as a monotherapy.
Parts 1 and 2: INB053914 100 mg BID	Experimental	Drug: INCB053914INCB053914 will be self-administered orally twice day in as a 100mg immediate release tablet as a monotherapy.
Parts 1 and 2: INB053914 115 mg	Experimental	Drug: INCB053914INCB053914 will be self-administered orally twice day in as a 115mg immediate release tablet as a monotherapy.

Who may qualify

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

Key inclusion criteria (14 listed)

Aged 18 years or older
Confirmed diagnosis of select advanced malignancy
Parts 1 and 2:
Parts 3 and 4:
Willingness to undergo a pretreatment bone marrow biopsy and/or aspirate, or archival sample obtained since completion of most recent therapy (as appropriate to subjects with existing bone marrow disease or for whom bone marrow examination is a component of disease status assessment)

Key exclusion criteria (8 listed)

Inadequate bone marrow or organ function
Received an investigational agent within 5 half-lives or 14 days, whichever is longer, prior to receiving the first dose of study drug
Received non-biologic anticancer medication within 5 half-lives prior to receiving the first dose of study drug (within 6 weeks for mitomycin-C or nitrosoureas), within 28 days for any antibodies or biological therapies
Prior receipt of a PIM inhibitor
Any history of disease involving the central nervous system (Part 1). Known active disease involving the central nervous system (Part 2).

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
INCB053914Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria. INCB053914 tablets to be administered by mouth.	Drug	Parts 1 and 2: INB053914 100 mg BID, Parts 1 and 2: INB053914 115 mg, Parts 1 and 2: INB053914 65 mg, Parts 1 and 2: INB053914 80 mg, Parts 1 and 2: INCB053914 100 mg QD, Parts 1 and 2: INCB053914 50 mg, Parts 3 and 4: INCB053914 + Azacitidine, Parts 3 and 4: INCB053914 + I-DAC (Intermediate dose cytarabine), Parts 3 and 4: INCB053914 + Ruxolitinib
I-DAC (Intermediate dose cytarabine)Cytarabine dose will be 1 g/m^2. Cytarabine will be administered as an intravenous (IV) infusion.	Drug	Parts 3 and 4: INCB053914 + I-DAC (Intermediate dose cytarabine)
AzacitidineAlso: Vidaza®Azacitidine dose will be 75 mg/m^2. Azacitidine will be administered either sub-cutaneously (SC) or intravenously (IV).	Drug	Parts 3 and 4: INCB053914 + Azacitidine
RuxolitinibStarting dose of ruxolitinib will be the dose the subject was on at study entry Ruxolitinib will be administered by mouth.	Drug	Parts 3 and 4: INCB053914 + Ruxolitinib

Primary outcome

Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events
Time frame: Approximately 7 months
Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With the Intermediate-dose Cytarabine (I DAC) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) Based on Objective Remission Rate (ORR)
Time frame: Approximately 2 months
The primary efficacy endpoint of ORR in patients with AML who received INCB053914 in combination with cytarabine in Part 4 was not assessed because Part 4 was not opened for enrollment owing to this combination regimen not being tolerated in Part 3.
Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With Azacitidine in Subjects With Newly Diagnosed AML Who Are 65 Years or Older and Unfit for Intensive Chemotherapy Based on ORR
Time frame: Approximately 6 months
The primary efficacy endpoint of ORR in patients with AML who received INCB053914 plus azacitidine in Part 4 was not performed due to limited enrollment as a result of early study termination.

21 secondary outcomes

Evaluation of Phosphorylated BCL--2 Associated Death Promoter Protein (pBAD)
Time frame: 1 month
Pharmacokinetics: Tmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Time frame: Cycle 1 Day 5
Pharmacokinetics: AUCtau of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Time frame: Cycle 1 Day 5
Pharmacokinetics: Cl/F of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Time frame: Cycle 1 Day 5
Pharmacokinetics: Cmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Time frame: Cycle 1 Day 5
Pharmacokinetics: Cmin of Combination Treatment Group A INCB053914 50 mg + Cytarabine
Time frame: Cycle 1 Day 5
Pharmacokinetics: Tmax of Combination Group B INCB053914 80 mg + Azatcitidine
Time frame: Cycle 1 Day 8
Pharmacokinetics: AUCtau of Combination Group B INCB053914 80 mg + Azatcitidine
Time frame: Cycle 1 Day 8
Pharmacokinetics: Cl/F of Combination Group B INCB053914 80 mg + Azatcitidine
Time frame: Cycle 1 Day 8
Pharmacokinetics: Cmax of Combination Group B INCB053914 80 mg + Azatcitidine
Time frame: Cycle 1 Day 8
Pharmacokinetics: Cmin of Combination Group B INCB053914 80 mg + Azatcitidine
Time frame: Cycle 1 Day 8
Pharmacokinetics: Tmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Time frame: Regimen 2 Week 4
Pharmacokinetics: AUCtau of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Time frame: Regimen 2 Week 4
Pharmacokinetics: Cl/F of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Time frame: Regimen 2 Week 4
Pharmacokinetics: Cmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Time frame: Regimen 2 Week 4
Pharmacokinetics: Cmin of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
Time frame: Regimen 2 Week 4
Pharmacokinetics: Tmax of INCB053914 Monotherapy
Time frame: Cycle 1 Day 8
Pharmacokinetics: AUCtau of INCB053914 Monotherapy
Time frame: Cycle 1 Day 8
Pharmacokinetics: CL/F of INCB053914 Monotherapy
Time frame: Cycle 1 Day 8
Pharmacokinetics: Cmax of INCB053914 Monotherapy
Time frame: Cycle 1 Day 8
Pharmacokinetics: Ctau of INCB053914 Monotherapy
Time frame: Cycle 1 Day 8

Results and safety

Results posted to the registry on 8 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Parts 1 and 2: INCB053914 100 mg QD	4	0
Parts 1 and 2: INCB053914 50 mg BID	11	0
Parts 1 and 2: INB053914 65 mg BID	4	0
Parts 1 and 2: INB053914 80 mg BID	21	0
Parts 1 and 2: INB053914 100 mg BID	12	0
Parts 1 and 2: INB053914 115 mg BID	6	0
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine	6	0
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine	7	0
Part 3 and 4 - INCB053914 80 mg BID + Azacitidine	9	0
Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib	3	0
Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib	14	0

Primary outcome: Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events

Time frame: Approximately 7 months. Number. Unit: Participants

Measure	Parts 1 and 2: INCB053914 100 mg QD n = 4	Parts 1 and 2: INCB053914 50 mg BID n = 11	Parts 1 and 2: INB053914 65 mg BID n = 4	Parts 1 and 2: INB053914 80 mg BID n = 21	Parts 1 and 2: INB053914 100 mg BID n = 12	Parts 1 and 2: INB053914 115 mg BID n = 3	Parts 3 and 4: INCB053914 50 mg BID + Cytarabine n = 6	Parts 3 and 4: INCB053914 50 mg BID + Azacitidine n = 7	Parts 3 and 4: INCB053914 80 mg BID + Azacitine n = 9	Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib n = 3	Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib n = 14
Value	4	11	4	21	12	6	6	7	9	3	14

Primary outcome: Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With the Intermediate-dose Cytarabine (I DAC) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) Based on Objective Remission Rate (ORR)

Time frame: Approximately 2 months

Population analysed: Part 4 was not opened for enrollment owing to combination regimen not being tolerated in Part 3.

Primary outcome: Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With Azacitidine in Subjects With Newly Diagnosed AML Who Are 65 Years or Older and Unfit for Intensive Chemotherapy Based on ORR

Time frame: Approximately 6 months

Population analysed: Part 4 was not opened for enrollment.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to approximately 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 and 2 - INCB053914: 100 mg QD	3 of 4 (75%)	4 of 4 (100%)	4 of 4
Part 1 and 2 - INCB053914: 50 mg BID	6 of 11 (54.5%)	11 of 11 (100%)	8 of 11
Part 1 and 2 - INCB053914: 65 mg BID	3 of 4 (75%)	4 of 4 (100%)	4 of 4
Part 1 and 2 - INCB053914: 80 mg BID	6 of 21 (28.6%)	20 of 21 (95.2%)	19 of 21
Part 1 and 2 - INCB053914: 100 mg BID	8 of 12 (66.7%)	12 of 12 (100%)	9 of 12
Part 1 and 2 - INCB053914: 115 mg BID	5 of 6 (83.3%)	6 of 6 (100%)	4 of 6
Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine	5 of 6 (83.3%)	6 of 6 (100%)	6 of 6
Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine	5 of 7 (71.4%)	7 of 7 (100%)	7 of 7
Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine	6 of 9 (66.7%)	8 of 9 (88.9%)	9 of 9
Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib	0 of 3 (0%)	3 of 3 (100%)	1 of 3
Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib	5 of 14 (35.7%)	14 of 14 (100%)	3 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37290996Patel MR, Donnellan W, Byrne M, Asch AS, Zeidan AM, Baer MR, Fathi AT, Kuykendall AT, Zheng F, Walker C, Cheng L, Marando C, Savona MR. Phase 1/2 Study of the Pan-PIM Kinase Inhibitor INCB053914 Alone or in Combination With Standard-of-Care Agents in Patients With Advanced Hematologic Malignancies. Clin Lymphoma Myeloma Leuk. 2023 Sep;23(9):674-686. doi: 10.1016/j.clml.2023.05.002. Epub 2023 May 15.

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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.

Fred Zheng, M.D. study director

Incyte Corporation

19 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 INCB053914, I-DAC (Intermediate dose cytarabine) and Azacitidine in people with Solid Tumors, run by Incyte Corporation at 19 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 14 inclusion and 8 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 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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 8 Dec 2021). 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?

Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events (time frame: Approximately 7 months). The study lists 3 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 NCT02587598, which also lists 1 linked publication.

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 8 Dec 2021.