To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)

Active:	No
Cancer Type:	Hematopoietic Malignancies Leukemia Unknown Primary	NCT ID:	NCT04551053
Trial Phases:	Phase III	Protocol IDs:	INCB 50465-304/LIMBER-304 (primary) NCI-2021-09614
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Incyte Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT04551053

Summary

The purpose of the study is to compare the efficacy and safety of parsaclisib when combined
with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis
who have suboptimal response while receiving ruxolitinib monotherapy.

Objectives

Prospective participants must be on stable doses of ruxolitinib ranging from 5 mg BID to 25
mg BID and will have been on that dose for at least the last 8 weeks prior to Day 1. At least
3 months duration of prior ruxolitinib is required. Participants must meet Protocol-defined
criteria for suboptimal response to ruxolitinib monotherapy. After participants have been
determined to be eligible for the study and completed the baseline symptom diary assessment
for 7 days, they will be randomized to 1 of 2 treatment groups, with stratification for
platelet count (= 100 × 10^9/L vs 50 to < 100 × 10^9/L inclusive) and DIPSS risk category
(high vs intermediate-2 vs intermediate-1).

Once a participant has completed the week 24 assessments, the participant's treatment
assignment will then be unblinded and if found to be placebo, the participant will have the
opportunity to crossover to begin receiving parsaclisib, together with continued ruxolitinib,
as long as hematology parameters are adequate.

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