Myelofibrosis(MF)

study of the JAK inhibitor Ruxolitinib administered orally to patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)

Incyte Study ID:
CINC424A2201
CT.gov ID:
NCT01317875
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
Novartis
Study Contact Information:
1.855.463.3463
Study Complete
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Results Available

Protocol
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Statistical Analysis Plan (SAP)
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Clinical Study Purpose

This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib in patients with myelofibrosis (MF). The study consists of two periods: the core study period, comprising the dose escalation stage and the safety extension phase up to Week 24, then the extension study period beyond Week 24 and up to 3 years, to further characterize the safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting platelet counts < 100 x 10 ^9/L

Clinical Study Summary

MEDICAL CONDITION(S)
  • Myelofibrosis(MF)
    • PRODUCT
  • Drug: Ruxolitinib
    • COLLABORATORS
    Novartis
    DATE
    Mar 2011 - Dec 2019
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    Winter Park, Florida, US, 32789
    Name
    Baltimore, Maryland, US, 21229
    Name
    Houston, TX, US, 77030
    Name
    Vienna, Austria
    Name
    Beijing, China
    Name
    Nanjing, Jiangsu, China

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Require treatment for MF and classified at least as intermediate risk level 1 defined by the International Working Group.
    • Platelet count < 100x10 ^9/L at screening or at Study Day 1.

    Exclusion Criteria

    • Received platelet transfusion within 14 days prior to Screening evaluations.

    Protocol Summary

    Incyte Study ID:
    CINC424A2201
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    69
    Primary Outcome
    Open

    Incidence of Dose Limiting Toxicities

    Timeframe: 28 days

    Secondary Outcome
    Open

    Treatment Emergent Adverse Events (TEAE's)

    Timeframe: approximately 4 years

    Number of subjects achieving ≥ 50% reduction in palpable spleen length

    Timeframe: 24 weeks

    Change in Spleen Length as measure by palpation over time

    Timeframe: 156 weeks

    PK- C Reactive Protein Relationship

    Timeframe: 24 weeks

    PK- Interleukin 1 Receptor Antagonist Relationship

    Timeframe: 24 weeks

    PK- Tissue Necrosis Factor Receptor 2 Relationship

    Timeframe: 24 weeks

    AUC 0-Inf

    Timeframe: 0.25 to 0.75, 1 to 3, and 4 to 12 hours postdose on Day 1 and predose, 0.25 to 0.75 hours, and 1 to 3 hours postdose on Day 15, with a random sample on Days 29 and 57