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)

  • STATUS
    Recruiting
  • End date
    Feb 1, 2023
  • participants needed
    60
  • sponsor
    Incyte Corporation
Updated on 1 April 2021

Summary

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.

Details
Condition Myelosclerosis with myeloid metaplasia, Thrombocytosis, Polycythemia Vera, Myelofibrosis, thrombocythemia
Treatment itacitinib
Clinical Study IdentifierNCT04821791
SponsorIncyte Corporation
Last Modified on1 April 2021

Eligibility

Yes No Not Sure

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
Prior treatment with ruxolitinib and/or fedratinib monotherapy
Currently receiving ruxolitinib or fedratinib monotherapy for PMF or secondary MF
Splenomegaly defined as palpable spleen at least 5 cm below the left costal margin or volume 450 cm3 on imaging assessed during screening
Allogeneic stem cell transplant not planned
Platelet is greater than or equal to 50 109/L at screening
Ability to comprehend and willingness to sign a written ICF for the study
Willingness to avoid pregnancy or fathering children

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
For participants on ruxolitinib or fedratinib, unable to be tapered from that treatment over the course of 14 days without corticosteroids, hydroxyurea, or other agents
Treatment with ruxolitinib, fedratinib or other MF-directed therapy (approved or investigational) within 2 weeks of Day 1
Prior splenectomy or splenic irradiation within 6 months before receiving the first dose of itacitinib
Unable or unwilling to undergo serial MRI or CT scans for spleen volume measurement
Unable or unwilling to complete MFSAF v4.0 diary on a daily basis during the study
ECOG performance status 3
Life expectancy less than 24 weeks
Not willing to receive RBC or platelet transfusions
Participants with laboratory values at screening outside of protocol defined ranges
Significant concurrent, uncontrolled medical condition
Participants with impaired cardiac function or clinically significant cardiac disease unless approved by medical monitor/sponsor
History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful
Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
Evidence of HBV or HCV infection or risk of reactivation
Known HIV infection
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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