Advanced/Metastatic

Study of INCB053914 in Subjects With Advanced Malignancies

Incyte Study ID:
INCB 53914-101
CT.gov ID:
NCT02587598
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463
Other
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Results Available

Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
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Clinical Study Purpose

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).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCB053914
  • Drug: I-DAC (Intermediate dose cytarabine)
  • Drug: Azacitidine
  • Drug: Ruxolitinib
    • COLLABORATORS
    N/A
    DATE
    Dec 2015 - Aug 2020
    TYPE
    Interventional
    PHASE
    Phase 1/Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    University of Alabama at Birmingham
    Birmingham, Alabama, US, 35294
    Name
    The University of Arizona Cancer Center
    Tuscan, Arizona, US, 85719
    Name
    UC Davis comprehensive Cancer Center
    Sacramento, California, US, 95817
    Name
    UCLA Medical Hematology & Oncology
    Santa Monica, CA, US, 90095
    Name
    Yale University
    New Haven, Connecticut, US, 06511
    Name
    Mayo Clinic Florida
    Jacksonville, FL, US, 32224

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Aged 18 years or older
    • Confirmed diagnosis of select advanced malignancy

    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

    Protocol Summary

    Incyte Study ID:
    INCB 53914-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    97
    Primary Outcome
    Open

    Determination of the safety and tolerability of INCB053914 as measured by the number of participants with adverse events

    Timeframe: Approximately 24 months

    Part 4 only : Determination of the efficacy of INCB053914 in combination with the intermediate-dose cytarabine (I DAC) in subjects with relapsed or refractory acute myeloid leukemia (AML) based on objective remission rate (ORR)

    Timeframe: Approximately 2 months

    Part 4 only : Determination of the efficacy of INCB053914 in combination with azacitidine in subjects with newly diagnosed AML who are 65 years or older and unfit for intensive chemotherapy based on ORR

    Timeframe: Approximately 6 months

    Part 4 only: Determination of the initial efficacy of INCB053914 in combination with select SOC agents as measured by the Objective Remission Rate (ORR)

    Timeframe: Approximately 24 months

    Determination of the efficacy of INCB053914 in combination with the intermediate-dose cytarabine (I DAC) in subjects with relapsed or refractory acute myeloid leukemia (AML) based on objective remission rate (ORR)

    Timeframe: Approximately 24 months

    Determination of the efficacy of INCB053914 in combination with azacitidine in subjects with newly diagnosed AML who are 65 years or older and unfit for intensive chemotherapy based on ORR

    Timeframe: Approximately 24 months

    Secondary Outcome
    Open

    Plasma concentrations oF INCB053914 will be determined by the use of validated assays

    Timeframe: Cycle 1, Cycle 2 (Part 2 food-effect cohort only), approximately 24 months

    Pharmacodynamic profile of INCB053914 determined by phosphorylation of Bcl-2-associated death promoter protein

    Timeframe: approximately 1 month

    Objective Remission Rate (ORR) of INCB053914 in subjects with measurable disease

    Timeframe: Baseline through end of study, approximately 24 months

    Part 4 only: Change and percentage change in spleen volume from baseline through Week 12 measured by MRI or CT in applicable subjects

    Timeframe: Baseline through end of study, approximately 24 months