A Study of the Safety and Tolerability of INCB053914 in People with Advanced Malignancies

Overview

  • Study type

    Interventional
  • Study phase

    I/II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 15-007313
    NCT ID: NCT02587598
    Sponsor Protocol Number: INCB 53914-101

About this study

The purpose of this study is to evaluate the safety, effectivenes, drug action, and drug/ body interactions, and to determine the maximum tolerated dose of PIM kinase inhibitor INCB053914 in people with advanced malignancies.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Age 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
  • Willing to undergo a pretreatment bone marrow biopsy and aspirate, or have an archival sample used
    • Collected 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Taimur Sher, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20302310

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