Advanced/Metastatic

An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies

Incyte Study ID:
INCB 59872-101
CT.gov ID:
NCT02712905
Eudra ID:
2017-001710-28
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/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCB059872
  • Drug: all-trans retinoic acid (ATRA)
  • Drug: azacitidine
  • Drug: nivolumab
    • COLLABORATORS
    N/A
    DATE
    May 2016 - Apr 2022
    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, 35487
    Name
    Moores UCSD Cancer Center
    La Jolla, CA, US, 92093
    Name
    UCLA Medical Center
    Los Angeles, CA, US, 90095
    Name
    Northwestern University
    Chicago, IL, US, 60208
    Name
    University of Kansas Center for Research, Inc.
    Kansas City, KS, US, 66045
    Name
    Roswell Park Cancer Institute
    Buffalo, NY, US, 14263

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Male or female subjects, age 18 years or older.
    • Presence of measurable disease that has been confirmed by histology or cytology.

    Exclusion Criteria

    • Receipt of anticancer medications, anticancer therapies, or investigational drugs within the defined interval before the first administration of study drug.
    • Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for stable chronic toxicities (≤ Grade 2) not expected to resolve.

    Protocol Summary

    Incyte Study ID:
    INCB 59872-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    116
    Primary Outcome
    Open

    Safety and tolerability of INCB059872 in monotherapy and in combination with other therapies as measured by the frequency, duration, and severity of adverse events (AEs) in participants, and determine recommended dose(s) for further study

    Timeframe: AEs assessed from screening through 30 days after end of treatment, up to 6 months

    Secondary Outcome
    Open

    Tumor response rates in subjects with measurable disease

    Timeframe: Tumor response at protocol-defined intervals from baseline through end of treatment, up to approximately 6 months

    Maximum observed plasma concentration (Cmax) of INCB059872

    Timeframe: 0.5, 1, 2, 4, 6 hours postdose on Days 1 and 15 in treatment Cycle 1 and for food effect in Cycle 2, up to approximately 1 month

    Area under the single-dose plasma concentration-time curve (AUC0-t) of INCB059872

    Timeframe: 0.5, 1, 2, 4, 6 hours postdose on Days 1 and 15 in treatment Cycle 1 and for food effect in Cycle 2, up to approximately 1 month