Study of INCB053914 in Subjects With Advanced Malignancies

Stopped early · Phase 1/Phase 2

Conditions studied: Solid Tumors

In brief

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).

Key facts

Study ID

NCT02587598

Run by

Incyte Corporation

People needed

97

Starts

2015-12-29

Expected to finish

2020-08-11

Last updated by the study team

2021-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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.

You may not qualify if…

• 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

Where it is running

• The University of Arizona Cancer Center — Tucson, Arizona, United States
• UC Davis comprehensive Cancer Center — Sacramento, California, United States
• UCLA Medical Hematology & Oncology — Santa Monica, California, United States
• Yale University — New Haven, Connecticut, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Florida Cancer Specialists & Research Institute — Sarasota, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Emory University-Winship Cancer Institute — Atlanta, Georgia, United States
• University of Maryland — Baltimore, Maryland, United States
• Dana-Farber Cancer Center — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Oncology Hematology Care Clinical Trials LLC — Cincinnati, Ohio, United States
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Texas Oncology — Austin, Texas, United States
• Texas Oncology — Tyler, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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