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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 36 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My spleen is enlarged and can be felt at least 5 cm below my ribcage.
Select...
I have active symptoms of myelofibrosis with a symptom score of 10 or more.
Select...
I have or am willing to get a bone marrow biopsy for my myelofibrosis diagnosis.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My condition is classified as intermediate-1, intermediate-2, or high risk.
Select...
I have been diagnosed with a form of myelofibrosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants achieving targeted reduction in spleen volume
Secondary outcome measures
Change in TSS
Duration of maintenance of targeted reduction in spleen volume
Number of Treatment Emergent Adverse Events (TEAE)
+4 moreTrial 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
~120
ruxolitinib
2017
Completed Phase 3
~600
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
54,913 Total Patients Enrolled
Albert Assad, M.DStudy DirectorIncyte Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had severe side effects from previous immunotherapy.I cannot swallow pills due to a condition in my upper digestive system.I haven't taken experimental drugs or standard treatments for myelofibrosis in the last 3 months.I haven't taken strong CYP3A4 affecting drugs recently or won't during the study.My liver and kidney functions are not normal.I have not fully recovered from major surgery complications.I am currently being treated for an infection.I have not received a live vaccine in the last 30 days.I am HIV positive.I do not have severe heart problems that could make the trial unsafe for me.My spleen is enlarged and can be felt at least 5 cm below my ribcage.I have active symptoms of myelofibrosis with a symptom score of 10 or more.I have or am willing to get a bone marrow biopsy for my myelofibrosis diagnosis.I have not taken drugs like INCB040093 or idelalisib for my condition.I have hepatitis B or C that needs treatment.My recent tests show low bone marrow function.I have had an active cancer within the last 2 years.I can take care of myself and am up and about more than half of my waking hours.My condition is classified as intermediate-1, intermediate-2, or high risk.I have been diagnosed with a form of myelofibrosis.I have previously used a JAK inhibitor medication.I have not had radiation treatment to my spleen in the last 6 months.I am not taking any medications that are not allowed in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group B : placebo + ruxolitinib
- Group 2: Group A : parsaclisib + ruxolitinib
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you tell me more about what parsaclisib is commonly used to treat?
"parsaclisib is a medication used to treat polycythemia vera, primary myelofibrosis, and other conditions including polycythemia that has not responded well to hydroxyurea."
Answered by AI
Are there different sites across the state conducting this clinical trial?
"There are 37 clinical trial sites for this particular study, located at medical centers such as Wake Forest Baptist Medical Center in Winston-Salem, University of Nebraska Medical Center in Omaha, and Oregon Health & Science University in Columbus, among other locations."
Answered by AI
Are there any spots still available for this research project?
"Yes, this study is still recruiting patients. The information on clinicaltrials.gov shows that the trial was first posted on 5/27/2021 and has been updated as recently as 10/17/2022."
Answered by AI
Has the FDA recognized parsaclisib as an effective treatment?
"There is both efficacy and safety data available for parsaclisib because it has progressed to Phase 3 trials. Consequently, our team at Power rates the safety of this medication as a 3."
Answered by AI
Are there other examples in which parsaclisib has been tested?
"Parsaclisib was first studied in 2002 at the National Institutes of Health Clinical Center. So far, there have been a total of 2783 completed studies. Currently, 114 parsaclisib studies are recruiting patients with a notable number taking place in Winston-Salem, North carolina."
Answered by AI
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