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PI3K Inhibitor

Parsaclisib + Ruxolitinib for Myelofibrosis

Phase 3

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

History of Grade 3 or 4 irAEs from prior immunotherapy

Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 749 days

Awards & highlights

Pivotal Trial

Summary

This trial will compare the effectiveness of a new drug, parsaclisib, to a placebo when used with another drug, ruxolitinib, to treat myelofibrosis.

Who is the study for?

This trial is for adults with myelofibrosis, a type of bone marrow cancer. They should have an intermediate to high risk level, be able to perform daily activities (ECOG score 0-2), and have a life expectancy over 24 weeks. Participants need a spleen that's enlarged by at least 5 cm and must not plan on becoming pregnant or fathering children.

What is being tested?

The study tests the effectiveness of combining parsaclisib with ruxolitinib versus using ruxolitinib with a placebo in treating myelofibrosis. The goal is to see if adding parsaclisib improves patient outcomes compared to just using ruxolitinib alone.

What are the potential side effects?

Possible side effects include digestive issues, liver problems, infections due to weakened immune system, blood disorders like anemia or thrombocytopenia (low platelet count), fatigue, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spleen is enlarged and can be felt at least 5 cm below my ribcage.

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I have active symptoms of myelofibrosis with a symptom score of 10 or more.

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I have or am willing to get a bone marrow biopsy for my myelofibrosis diagnosis.

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I can take care of myself and am up and about more than half of my waking hours.

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My condition is classified as intermediate-1, intermediate-2, or high risk.

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I have been diagnosed with a form of myelofibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had severe side effects from previous immunotherapy.

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I cannot swallow pills due to a condition in my upper digestive system.

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I haven't taken strong CYP3A4 affecting drugs recently or won't during the study.

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My liver and kidney functions are not normal.

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I am currently being treated for an infection.

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I have not received a live vaccine in the last 30 days.

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I am HIV positive.

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I have not taken drugs like INCB040093 or idelalisib for my condition.

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I have hepatitis B or C that needs treatment.

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I have had an active cancer within the last 2 years.

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I have previously used a JAK inhibitor medication.

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I am not taking any medications that are not allowed in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 749 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 749 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 749 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving ≥35% Reduction in Spleen Volume From Baseline to Week 24 as Measured by Magnetic Resonance Imaging [MRI] (or Computed Tomography [CT] Scan in Applicable Participants)

Secondary study objectives

Change in TSS From Baseline to Week 24 as Measured by the MFSAF v4.0 Diary

Duration of Maintenance of a ≥35% Reduction in Spleen Volume

Number of Participants With Any Grade 3 or Higher TEAE

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group A : parsaclisib + ruxolitinibExperimental Treatment2 Interventions

Participants will receive parsaclisib and ruxolitinib starting from Day 1 for the duration of study, ruxolitinib dose will be determined by baseline platelet count.

Group II: Group B : placebo + ruxolitinibPlacebo Group2 Interventions

Participants will receive placebo and ruxolitinib starting from Day 1 for the duration of study, ruxolitinib dose will be determined by baseline platelet count.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

parsaclisib

2021

Completed Phase 2

~170

ruxolitinib

2017

Completed Phase 3

~660