NCT02587598 is a Phase 1, PHASE2 clinical trial of INCB053914 in Solid Tumors, sponsored by Incyte Corporation.

Who is sponsoring NCT02587598?

NCT02587598 is sponsored by Incyte Corporation.

What drugs are being tested in NCT02587598?

Interventions in NCT02587598: INCB053914, I-DAC (Intermediate dose cytarabine), Azacitidine, Ruxolitinib.

What condition does NCT02587598 study?

NCT02587598 studies Solid Tumors.

Is NCT02587598 still recruiting?

NCT02587598 is currently terminated. Last updated 8 December 2021.

Are results published for NCT02587598?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-12-08 · How we verify

NCT02587598

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of INCB053914 in Subjects With Advanced Malignancies

Terminated Phase 1, PHASE2 Results posted Last updated 8 December 2021

What this trial tests

Phase 1, PHASE2 trial testing INCB053914 in Solid Tumors in 97 participants. Terminated before completion.

Timeline

29 December 2015

Primary endpoint
11 August 2020

11 August 2020

Quick facts

Lead sponsor	Incyte Corporation
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	97
Start date	29 December 2015
Primary completion	11 August 2020
Estimated completion	11 August 2020
Sites	19 locations across United States

Drugs / interventions tested

INCB053914 — full drug profile →
I-DAC (Intermediate dose cytarabine) — full drug profile →
Azacitidine (azacitidine) — full drug profile →
Ruxolitinib (RUXOLITINIB) — full drug profile →

Conditions studied

Solid Tumors — all drugs for Solid Tumors →

Sponsor

Incyte Corporation — full company profile →

Who can join

18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events Primary · Approximately 7 months

Group	Value	95% CI
Parts 1 and 2: INCB053914 100 mg QD	4
Parts 1 and 2: INCB053914 50 mg BID	11
Parts 1 and 2: INB053914 65 mg BID	4
Parts 1 and 2: INB053914 80 mg BID	21
Parts 1 and 2: INB053914 100 mg BID	12
Parts 1 and 2: INB053914 115 mg BID	6
Parts 3 and 4: INCB053914 50 mg BID + Cytarabine	6
Parts 3 and 4: INCB053914 50 mg BID + Azacitidine	7
Parts 3 and 4: INCB053914 80 mg BID + Azacitine	9
Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib	3
Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib	14

Evaluation of Phosphorylated BCL--2 Associated Death Promoter Protein (pBAD) Secondary · 1 month

Percent Inhibition of pBAD at the C1D15 trough from the pBAD at pre-dose by ex vivo cellular assay

Group	Value	95% CI
Parts 1 and 2: INCB053914 100 mg QD	41	16 – 67
Parts 1 and 2: INCB053914 50 mg BID	37	17 – 59
Parts 1 and 2: INB053914 65 mg BID	68	52 – 91
Parts 1 and 2: INB053914 80 mg BID	78	63 – 104
Parts 1 and 2: INB053914 100 mg BID	55	28 – 92
Parts 1 and 2: INB053914 115 mg BID	58	34 – 80

Pharmacokinetics: Tmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine Secondary · Cycle 1 Day 5

Group	Value	95% CI
Parts 3 & 4: INCB053914 50 mg BID + Cytarabine	1.52	1 – 2.07

Pharmacokinetics: AUCtau of Combination Treatment Group A INCB053914 50 mg + Cytarabine Secondary · Cycle 1 Day 5

Group	Value	95% CI
Parts 3 & 4: INCB053914 50 mg BID + Cytarabine	2860	± 2040

Pharmacokinetics: Cl/F of Combination Treatment Group A INCB053914 50 mg + Cytarabine Secondary · Cycle 1 Day 5

Group	Value	95% CI
Parts 3 & 4: INCB053914 50 mg BID + Cytarabine	122	± 213

Pharmacokinetics: Cmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine Secondary · Cycle 1 Day 5

Group	Value	95% CI
Parts 3 & 4: INCB053914 50 mg BID + Cytarabine	423	± 283

Pharmacokinetics: Cmin of Combination Treatment Group A INCB053914 50 mg + Cytarabine Secondary · Cycle 1 Day 5

Group	Value	95% CI
Parts 3 & 4: INCB053914 50 mg BID + Cytarabine	139	± 101

Pharmacokinetics: Tmax of Combination Group B INCB053914 80 mg + Azatcitidine Secondary · Cycle 1 Day 8

Group	Value	95% CI
Parts 3 & 4: INCB053914 80 mg BID + Azacitidine	2	1 – 4

Pharmacokinetics: AUCtau of Combination Group B INCB053914 80 mg + Azatcitidine Secondary · Cycle 1 Day 8

Group	Value	95% CI
Parts 3 & 4: INCB053914 80 mg BID + Azacitidine	11000	± 11100

Pharmacokinetics: Cl/F of Combination Group B INCB053914 80 mg + Azatcitidine Secondary · Cycle 1 Day 8

Group	Value	95% CI
Parts 3 & 4: INCB053914 80 mg BID + Azacitidine	30.8	± 24.7

Pharmacokinetics: Cmax of Combination Group B INCB053914 80 mg + Azatcitidine Secondary · Cycle 1 Day 8

Group	Value	95% CI
Parts 3 & 4: INCB053914 80 mg BID + Azacitidine	1320	± 1240

Pharmacokinetics: Cmin of Combination Group B INCB053914 80 mg + Azatcitidine Secondary · Cycle 1 Day 8

Group	Value	95% CI
Parts 3 & 4: INCB053914 80 mg BID + Azacitidine	513	± 431

Adverse events — posted to ClinicalTrials.gov

Time frame: up to approximately 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1 and 2 - INCB053914: 100 mg QD

Serious: 3/4 (75%)

Deaths: 4/4

Part 1 and 2 - INCB053914: 50 mg BID

Serious: 6/11 (55%)

Deaths: 8/11

Part 1 and 2 - INCB053914: 65 mg BID

Serious: 3/4 (75%)

Deaths: 4/4

Part 1 and 2 - INCB053914: 80 mg BID

Serious: 6/21 (29%)

Deaths: 19/21

Part 1 and 2 - INCB053914: 100 mg BID

Serious: 8/12 (67%)

Deaths: 9/12

Part 1 and 2 - INCB053914: 115 mg BID

Serious: 5/6 (83%)

Deaths: 4/6

Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine

Serious: 5/6 (83%)

Deaths: 6/6

Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine

Serious: 5/7 (71%)

Deaths: 7/7

Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine

Serious: 6/9 (67%)

Deaths: 9/9

Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib

Serious: 0/3 (0%)

Deaths: 1/3

Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib

Serious: 5/14 (36%)

Deaths: 3/14

Serious adverse events (77 terms)

Reaction	System	Part 1 and 2 - INCB053914:…	Part 1 and 2 - INCB053914:…	Part 1 and 2 - INCB053914:…	Part 1 and 2 - INCB053914:…	Part 1 and 2 - INCB053914:…	Part 1 and 2 - INCB053914:…	Part 3 and 4 - INCB053914:…	Part 3 and 4 - INCB053914:…	Part 3 and 4 - INCB053914:…	Part 3 and 4 - INCB053914:…	Part 3 and 4 - INCB053914:…
Disease progression	General disorders	—	—	—	—	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Clostridium difficile infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—
Acute febrile neutrophilic dermatosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Carotid artery occlusion	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Haemorrhagic infarction	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Infective myositis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (230 terms — click to expand)

Reaction	System	Part 1 and 2 - INCB053914:…	Part 1 and 2 - INCB053914:…	Part 1 and 2 - INCB053914:…	Part 1 and 2 - INCB053914:…	Part 1 and 2 - INCB053914:…	Part 1 and 2 - INCB053914:…	Part 3 and 4 - INCB053914:…	Part 3 and 4 - INCB053914:…	Part 3 and 4 - INCB053914:…	Part 3 and 4 - INCB053914:…	Part 3 and 4 - INCB053914:…
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Disease progression, Febrile neutropenia, Pneumonia, Sepsis, Pyrexia, Rash maculo-papular, Clostridium difficile infection, Haematuria.

Data from ClinicalTrials.gov NCT02587598 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting Pim kinases in hematological cancers: molecular and clinical review.
Bellon M, Nicot C. · · 2023 · cited 58× · PMID 36694243 · DOI 10.1186/s12943-023-01721-1
JAK Inhibition for the Treatment of Myelofibrosis: Limitations and Future Perspectives.
Bose P, Verstovsek S. · · 2020 · cited 51× · PMID 32903304 · DOI 10.1097/hs9.0000000000000424
Preclinical characterization of INCB053914, a novel pan-PIM kinase inhibitor, alone and in combination with anticancer agents, in models of hematologic malignancies.
Koblish H, Li YL, Shin N, Hall L, et al · · 2018 · cited 42× · PMID 29927999 · DOI 10.1371/journal.pone.0199108
The pan-PIM inhibitor INCB053914 displays potent synergy in combination with ruxolitinib in models of MPN.
Mazzacurati L, Collins RJ, Pandey G, Lambert-Showers QT, et al · · 2019 · cited 24× · PMID 31725895 · DOI 10.1182/bloodadvances.2019000260
Management of myelofibrosis after ruxolitinib failure.
Bose P, Verstovsek S. · · 2020 · cited 16× · PMID 32297800 · DOI 10.1080/10428194.2020.1749606
Finding a Jill for JAK: Assessing Past, Present, and Future JAK Inhibitor Combination Approaches in Myelofibrosis.
Kuykendall AT, Horvat NP, Pandey G, Komrokji R, et al · · 2020 · cited 15× · PMID 32823910 · DOI 10.3390/cancers12082278
Pim Kinases: Important Regulators of Cardiovascular Disease.
Nock S, Karim E, Unsworth AJ. · · 2023 · cited 13× · PMID 37511341 · DOI 10.3390/ijms241411582
Targeting PIM Kinases to Improve the Efficacy of Immunotherapy.
Clements AN, Warfel NA. · · 2022 · cited 12× · PMID 36429128 · DOI 10.3390/cells11223700

Verify or expand the search:

Other trials of INCB053914

Trials testing the same drug.

NCT03688152 — A Safety and Tolerability Study of INCB053914 in Combination With INCB050465 in Diffuse Large B-Cell Lymphoma · Phase 1 · completed

Other recruiting trials for Solid Tumors

Currently open trials in the same condition.

NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
NCT07395258 — A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Differe · Phase 1 · recruiting
NCT07505069 — Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors · EARLY_PHASE1 · recruiting

Other Incyte Corporation trials

Trials by the same sponsor.

NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di · Phase 2 · recruiting
NCT07441694 — Study of INCA036978 in Participants With Myeloproliferative Neoplasms · Phase 1 · recruiting
NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not recruiting
NCT07284849 — A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 i · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02587598 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
Last refreshed: 8 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02587598.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing