To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Partic… (NCT04629508) | Clinical Trial Compass
CompletedPhase 2
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)
United States4 participantsStarted 2021-07-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Timeframe: up to 724 days
2
Part 1: Number of Participants With Any Grade 3 or Higher TEAE