INCB 50465-304 Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis
What is the Purpose of this Study?
This study has 2 parts. If you choose to join:
- In Part 1, you will be randomly assigned (like a coin flip) to get either the study drug + ruxolitinib or placebo + ruxolitinib. After 24 weeks, you will move into Part 2.
- In Part 2, you will have the opportunity to take the study drug if you were assigned to receive placebo in Part 1.
The dose of ruxolitinib you take will depend on the amount you took before taking part in the study and will range from 5 mg to 25 mg. Participants will take ruxolitinib twice a day by mouth.
- In Part 1, you will be randomly assigned (like a coin flip) to get either the study drug + ruxolitinib or placebo + ruxolitinib. After 24 weeks, you will move into Part 2.
- In Part 2, you will have the opportunity to take the study drug if you were assigned to receive placebo in Part 1.
The dose of ruxolitinib you take will depend on the amount you took before taking part in the study and will range from 5 mg to 25 mg. Participants will take ruxolitinib twice a day by mouth.
What is the Condition Being Studied?
Myelofibrosis
Who Can Participate in this Study?
Adults who:
- Are diagnosed with myelofibrosis
- Have spleen enlargement from their therapy
For more information about who can join this study, please contact the study team at peggy.alton@duke.edu or 919-684-9220.
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to find out if an investigational drug called parsaclisib (the study drug) is a safe and effective addition to ruxolitinib therapy in patients with myelofibrosis. We want to compare how the study drug works versus a placebo (inactive substance) for people who continue to have enlargement of the spleen while being treated with ruxolitinib for myelofibrosis.
Study Details
Full Title
A Randomized, Double-Blind, Placebo-Controlled Study of the PI3K? Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib
Principal Investigator
Protocol Number
IRB:
PRO00107348
NCT:
NCT04551053
ClinicalTrials.gov
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