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BET Inhibitor

INCB57643 + Ruxolitinib for Myelofibrosis

Phase 2
Waitlist Available
Led By Mahesh Swaminathan, MBBS
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤ 2
Be older than 18 years old
Must not have
Prior splenectomy
Prior treatment with a BET inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to study the effectiveness of a combination of drugs, INCB05643 and ruxolitinib, in patients with myelofibrosis who have not been previously treated with J

Who is the study for?
This trial is for patients who have primary myelofibrosis or myelofibrosis and haven't been treated with JAK inhibitors before. Specific inclusion and exclusion criteria details are not provided, but typically these would outline the health status required to participate.
What is being tested?
The study is testing a combination of two drugs: INCB57643, which is a BET inhibitor, and Ruxolitinib. The goal is to see how effective this combo is for patients who have never taken JAK inhibitors.
What are the potential side effects?
While specific side effects aren't listed here, BET inhibitors like INCB57643 can cause gastrointestinal symptoms, fatigue, and blood-related issues; Ruxolitinib may lead to anemia, low platelet counts, dizziness among other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had my spleen removed.
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I have been treated with a BET inhibitor before.
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I have been treated with a JAK inhibitor like ruxolitinib.
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I do not have an active or chronic infection with TB, HIV, Hepatitis B, or Hepatitis C.
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My high blood pressure is not controlled despite taking the maximum treatment.
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I have not had a serious infection in the last 2 weeks.
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I have been diagnosed with PML.
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I have not had a major bleeding event in the past 6 months.
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My liver condition is classified as moderate to severe.
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I have severe anemia due to a specific medical condition.
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I had my spleen removed less than 6 months ago.
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I am not allergic to ruxolitinib or have specific rare genetic issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Adverse Events (AEs). Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: INCB+ RExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1170

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,616 Total Patients Enrolled
Mahesh Swaminathan, MBBSPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center
~20 spots leftby Apr 2027
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