INCB057643 +/- Ruxolitinib for Myelofibrosis
(LIMBER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new drug called INCB057643, alone or with ruxolitinib, for patients with certain blood cancers like myelofibrosis. The goal is to see if it can stop cancer growth or help other treatments work better. Ruxolitinib has been approved for the treatment of myelofibrosis and has shown clinical benefits in reducing symptoms and improving survival.
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but it does mention that you cannot use certain medications like potent CYP3A4 inhibitors or inducers within 14 days before starting the study treatment. If you are currently taking ruxolitinib and have a suboptimal response, you can continue it at your current dose.
Is the treatment with INCB057643 and Ruxolitinib safe for humans?
Ruxolitinib, used for treating myelofibrosis, has been studied extensively and is generally well-tolerated, with common side effects like anemia (low red blood cell count) and thrombocytopenia (low platelet count) that are usually manageable. No new safety concerns have been identified in recent studies, and non-blood-related side effects are mostly mild.12345
How does the drug INCB057643 differ from other treatments for myelofibrosis?
INCB057643 is a novel drug that targets BET proteins, which are involved in regulating gene expression, making it different from ruxolitinib, a JAK inhibitor that targets specific enzymes involved in cell signaling. This unique mechanism of action may offer an alternative for patients who do not respond well to existing treatments like ruxolitinib.26789
Are You a Good Fit for This Trial?
This trial is for adults with myelofibrosis or other advanced myeloid neoplasms who have tried at least one treatment without success. They must not be candidates for a stem-cell transplant and agree to prevent pregnancy. A palpable spleen of certain size and specific disease risk categories are required.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive INCB057643 as monotherapy or in combination with ruxolitinib for dose escalation and dose expansion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- INCB057643
- Ruxolitinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School