Advanced/Metastatic

Open-Label Safety and Tolerability Study of INCB057643 in Subjects with Advanced Malignancies

Incyte Study ID:
INCB 57643-101
CT.gov ID:
NCT02711137
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 and Statistical Analysis Plan
Available Languages: English
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Clinical Study Purpose

The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies.

Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCB057643
  • Drug: Gemcitabine
  • Drug: Paclitaxel
  • Drug: Rucaparib
  • Drug: Abiraterone
  • Drug: Ruxolitinib
  • Drug: Azacitidine
    • COLLABORATORS
    N/A
    DATE
    May 2016 - Feb 2019
    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
    Birmingham, AL, US, 35294-3300
    Name
    University of California
    La Jolla, CA, US, 92093
    Name
    Sarah Cannon Research Institute at Health One
    Denver, Colorado, US, 80218
    Name
    Yale University
    New Haven, CT, US, 06510
    Name
    Sylvester Comprehensive Cancer Center
    Miami, FL, US, 33136
    Name
    Hematology - Oncology Associates of Treasure Coast
    Port St. Lucie, FL, US, 34952

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histologically or cytologically confirmed diagnosis of relapsed or refractory advanced or metastatic malignancies:
    • * Part 1: solid tumors or lymphomas, or hematologic malignancies

    Exclusion Criteria

    • Inadequate bone marrow function per protocol-specified hemoglobin, platelet count, and absolute neutrophil count
    • Inadequate organ function per protocol-specified total bilirubin, AST and ALT, creatinine clearance and alkaline phosphatase.

    Protocol Summary

    Incyte Study ID:
    INCB 57643-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    137
    Primary Outcome
    Open

    Safety and tolerability of INCB057643 as monotherapy and in combination with standard of care (SOC) agents in patients with advanced malignancies; assessed by clinical laboratory assessments, physical examinations, 12 lead ECGs, and adverse events (AEs)

    Timeframe: From screening through at least 30 days after end of treatment, up to approximately 24 months

    Secondary Outcome
    Open

    Pharmacokinetics of INCB057643 as monotherapy in the fasted state and in the fed state (food effect; Part 2 only) and when administered in combination with Standard of Care (SOC) agents in the fasted state assessed by plasma and urine concentrations

    Timeframe: Protocol-defined timepoints in treatment Cycle 1 and 2, up to approximately 1 month.

    Measurement of cellular myc protein concentrations before and after administration of INCB057643 when administered as monotherapy

    Timeframe: PD in plasma at pre-dose and 0.5, 1, 2, 4, 6 and 8 hours postdose, up to approximately 1 month.

    Efficacy of INCB057643 when administered as monotherapy and in combination with SOC agents based on the investigator assessment of response using criteria appropriate for each disease in subjects with advanced malignancies criteria

    Timeframe: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months