To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)
Hematopoietic Malignancies
Leukemia
Unknown Primary
18 Years and older, Male and Female
INCB 50465-304/LIMBER-304 (primary)
NCI-2021-09614
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.
Eligibility
- Diagnosis of PMF, PPV-MF, or PET-MF.
- DIPSS risk category of intermediate-1, intermediate-2, or high.
- Treated with ruxolitinib for = 3 months with a stable dose for at least the last 8 weeks prior to Day 1
- Palpable spleen of = 5 cm below the left costal margin on physical examination at the screening visit.
- Active symptoms of MF at the screening visit, as demonstrated by the presence of a TSS of = 10 using the Screening Symptom Form.
- Participants with an ECOG performance status score of 0, 1, or 2.
- Screening bone marrow biopsy specimen and pathology report(s) available that was obtained within the prior 2 months or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24 and every 24 weeks there after. Screening/baseline biopsy specimen must show diagnosis of MF.
- Life expectancy of at least 24 weeks.
- Willingness to avoid pregnancy or fathering children.
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