Study of INCB053914 in Subjects With Advanced Malignancies

Overview

This is an open-label, dose-escalation study of the PIM kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 2 parts.

  • Part 1 (dose escalation) will evaluate safety, and determine the maximum tolerated dose of INCB053914 and the recommended phase 2 dose (a tolerated pharmacologically active dose that will be taken forward into Part 2 of the study).

  • Part 2 (dose expansion) will further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the recommended Phase 2 dose.

SparkCures ID 774
Trial Phase Phase 1/2
Enrollment 145 Patients
Treatments
Trial Sponsors
  • Incyte Corporation
NCT Identifier

NCT02587598

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

Inclusion Criteria:

  • Aged 18 years or older
  • Confirmed diagnosis of select advanced malignancy
  • Unresponsive to currently available therapy and there is no standard-of-care therapy available, in the judgment of the investigator
  • Willingness to undergo a pretreatment bone marrow biopsy and 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
  • Not currently a candidate for curative treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status
    • Part 1: 0 or 1
    • Part 2: 0, 1, or 2
  • Life expectancy > 12 weeks

Exclusion Criteria:

  • 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 anticancer medication or anticancer therapy within 5 half-lives prior to receiving the first dose of study drug (within 6 weeks for mitomycin-C or nitrosoureas)
  • Prior receipt of a PIM inhibitor
  • Known active disease involving the central nervous system
  • Screening 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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Florida Cancer Specialists
South

Fort Myers, FL

Mayo Clinic (Jacksonville)

Jacksonville, FL

Oncology Hematology Care Inc. (Kenwood)

Deer Park, OH

Stephenson Cancer Center

Oklahoma City, OK

Tennessee Oncology
Centennial Clinic

Nashville, TN

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

University of Rochester Medical Center
James P. Wilmot Cancer Center

Rochester, NY

Alabama
California
Connecticut
Florida
Florida Cancer Specialists
South

Fort Myers, FL

Mayo Clinic (Jacksonville)

Jacksonville, FL

Illinois
Massachusetts
Michigan
Nebraska
New York
University of Rochester Medical Center
James P. Wilmot Cancer Center

Rochester, NY

Ohio
Oncology Hematology Care Inc. (Kenwood)

Deer Park, OH

Oklahoma
Stephenson Cancer Center

Oklahoma City, OK

Tennessee
Tennessee Oncology
Centennial Clinic

Nashville, TN

Texas

Resources

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