Study of INCB053914 in Subjects With Advanced Malignancies
Public ClinicalTrials.gov record NCT02587598. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Study of INCB053914 in Subjects With Advanced Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02587598
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 97 participants
Conditions and interventions
Conditions
Interventions
- INCB053914 Drug
- I-DAC (Intermediate dose cytarabine) Drug
- Azacitidine Drug
- Ruxolitinib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 28, 2015
- Primary completion
- Aug 10, 2020
- Completion
- Aug 10, 2020
- Last update posted
- Dec 7, 2021
2015 – 2020
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | 85719 | — |
| UC Davis comprehensive Cancer Center | Sacramento | California | 95817 | — |
| UCLA Medical Hematology & Oncology | Santa Monica | California | 90095 | — |
| Yale University | New Haven | Connecticut | 06511 | — |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | — |
| Florida Cancer Specialists & Research Institute | Sarasota | Florida | 33916 | — |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | — |
| Emory University-Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Dana-Farber Cancer Center | Boston | Massachusetts | 02215 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 69198 | — |
| Oncology Hematology Care Clinical Trials LLC | Cincinnati | Ohio | 45236 | — |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Oncology | Austin | Texas | 78705 | — |
| Texas Oncology | Tyler | Texas | 75702 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02587598, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 7, 2021 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02587598 live on ClinicalTrials.gov.