Myelofibrosis(MF), Polycythemia Vera (PV)

To assess the safety, tolerability and efficacy of itacitinib immediate release tablets in participants with Primary or Secondary Myelofibrosis who have received prior ruxolitinib and/or fedratinib monotherapy (LIMBER-213)

Incyte Study ID:
INCB 39110-213/LIMBER-213
CT.gov ID:
NCT04629508
View Results Summary
Eudra ID:
2020-003123-42
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Protocol and Statistical Analysis Plan
Available Languages: English
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Clinical Study Purpose

This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Myelofibrosis(MF)
  • Polycythemia Vera (PV)
    • PRODUCT
  • Drug: itacitinib
    • COLLABORATORS
    N/A
    DATE
    Jul 2021 - Aug 2023
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    RENOVATIO CLINICAL CONSULTANTS LLC
    SPRING, TX, US, 77380
    Name
    NEW JERSEY HEMATOLOGY ONCOLOGY ASSOCIATES LLC
    BRICK, NJ, US, 08724-3009
    Name
    MIDAMERICA CANCER CARE
    KANSAS CITY, MO, US, 64114
    Name
    RCCA MD, LLC
    BETHESDA, MD, US, 20817
    Name
    VANDERBILT UNIVERSITY
    NASHVILLE, TN, US, 37235
    Name
    CHU UCL NAMUR UNIVERSITY HOSPITAL MONT-GODINNE
    YVOIR, Belgium, 05530

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Diagnosis of primary MF meeting the 2016 WHO criteria for overt PMF or secondary MF (PPV-MF or PET-MF) meeting the 2008 IWG-MRT criteria.
    • At least Intermediate 1 risk MF according to the DIPSS.

    Exclusion Criteria

    • Prior treatment with a JAK inhibitor other than ruxolitinib or fedratinib
    • Record of ≥ 10% myeloid blasts in the peripheral blood (on peripheral blood smear) or bone marrow prior to or at the time of screening

    Protocol Summary

    Incyte Study ID:
    INCB 39110-213/LIMBER-213
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    4
    Primary Outcome
    Open

    Part 1 : Treatment Emergent Adverse Events (TEAE'S)

    Timeframe: 24 Weeks

    Part 2 : Spleen Volume Reduction by MRI/CT Scan

    Timeframe: 24 weeks

    Part 2 : Spleen Volume Reduction

    Timeframe: 24 weeks

    Secondary Outcome
    Open

    Part 2 : Treatment Emergent Adverse Events (TEAE'S)

    Timeframe: 13 months

    Part 2 : Improvement in Total Symptom Score (TSS)

    Timeframe: 24 Weeks

    Part 2 : Improvement in quality of life.

    Timeframe: 24 weeks

    Part 2 : Improvement in Patient Global Impression of Change (PGIC)

    Timeframe: 24 Weeks