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MyelofibrosisPhase 2NCT06619522

A Phase 2 Study of INCB57643 (BET Inhibitor) in Combination With Ruxolitinib in JAK Inhibitor-naïve Patients With Myelofibrosis

A Phase 2 study testing Ruxolitinib and INCB57643 in people with Myelofibrosis, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To assess INCB05643 + ruxolitinib JAKi-naive patients with myelofibrosis Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelofibrosis
What is being tested?
Ruxolitinib and INCB57643
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
11 Sep 2024to 9 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (aged ≥ 18 years). Because no dosing or adverse event data are currently available on the use of ruxolitinib in combination with INC057643 in patients \<18 years of age, children are excluded from this study.
  • Patients with confirmed diagnosis of MF who meet all of the following criteria:
  • DIPSS-plus (see Appendix 3) risk category of intermediate-1, intermediate-2, or high
  • Platelet count ≥100 × 109/L without the assistance of thrombopoietic factors or transfusions
  • ANC ≥1 × 109/L without the assistance of granulocyte growth factors
  • Spleen volume of ≥450 cm3 by MRI/CT or spleen length ≥5 cm below the left costal margin
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  • Peripheral blood blast count \<10% at the screening hematology assessment
  • At least 2 symptoms that are measurable (each with a score 3) or 1 symptom with a score of 5 or a total symptom score of 10 using the MFSAF v4.0
  • No prior treatment with JAKi or BETi allowed
  • ECOG performance status ≤ 2 (Appendix 1)
  • Life expectancy of \>24 weeks
  • Serum total bilirubin ≤1.5 × ULN (total bilirubin \>1.5 × ULN is acceptable if direct bilirubin ≤ 1.2 × ULN or with a diagnosis of Gilbert\'s syndrome)
  • AST and ALT ≤2.5 × ULN. The AST and /or ALT may be elevated up to 5 × ULN if the elevation can be reasonably ascribed to liver involvement.
  • Calculated or measured CrCl ≥50 mL/min (either measured or estimated by the Cockcroft- Gault formula) {Cockcroft-Gault formula for eCrCl: eCrCl = (140 - Age) × Mass (kg) × [0.85 if Female]/ 72 × Serum Creatinine (mg/dL)} or GFR ≥50 ml/min/1.73 m2 calculated by the Modification of Diet in Renal Disease formula.
  • Patients must have fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy (residual CTCAE Grade 1 toxicity, e.g., Grade 1 peripheral neuropathy, and residual alopecia are allowed).
  • Both male and female patients and partners of patients, with reproductive potential, must agree to use at least one highly effective contraceptive method while on study therapy and for 90 days after the last dose of INCB057643 for male patients and male partners of female patients, and for 180 days after the last dose of study drug for female patients and female partners of male patients. NOTE: Patients may consider seeking information from the study investigator regarding donation and cryopreservation of germ cells prior to treatment. Male patients should be informed of the risk of testicular toxicity and provided with adequate advice regarding sperm preservation.
  • Patients must give written informed consent to participate in this study before the performance of any study-related procedure.

Who cannot join

  • Prior treatment with a BET inhibitor.
  • Prior treatment with a JAK inhibitor, including ruxolitinib.
  • Patients who have had a prior splenectomy.
  • Patients who have had splenic irradiation within 6 months of starting study treatment.
  • Current known active or chronic infection with TB, HIV, Hepatitis B, or Hepatitis C. Screening of patients with serologic testing for these viruses is not required. However, patients who have a past history of viral hepatitis or in whom there is a current suspicion of viral hepatitis should have DNA/RNA testing for Hepatitis B and Hepatitis C performed to determine whether there is any current evidence for ongoing infection with these viruses. Patients considered to be at risk for HIV infection should have HIV testing performed. Testing for COVID-19 is not mandatory during the screening for this study. However, based on the local epidemiologic situation and each patient's individual COVID-19 exposure risk and/or vaccination status, investigators should consider testing and in the case of COVID-19 positivity consider delaying the start of the study treatment until the infection is resolved.
  • Patients with active clinically significant infection will not be eligible for enrollment until recovery for at least 2 weeks prior to the first dose of study drug.
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  • Patients with anemia deemed clinically significant by the investigator from iron deficiency, B12 and folate deficiencies, or hemolytic anemia.
  • Patient with a major bleeding event causing a decrease in Hgb of ≥2g/dL or leading to transfusion of ≥2 units of packed red cells in the last 6 months prior to enrollment.
  • Patients with liver cirrhosis Child-Pugh Class B or C (see Appendix 4).
  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption or patients with hypersensitivity to any ingredient in the formulation of ruxolitinib.
  • Patients who have or have had progressive multifocal leukoencephalopathy (PML).
  • Ongoing uncontrolled hypertension despite maximal antihypertensive treatment.
  • Any other concurrent severe and/or uncontrolled concomitant medical condition that in the opinion of the investigator could compromise participation in the study or analysis of study data. This includes but is not limited to clinically significant pulmonary disease or neurological disorders, or active or uncontrolled infections.
  • Systemic anticancer treatment other than hydroxyurea (HU) and anagrelide (ANA) less than 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study treatment. NOTE: HU and ANA are permitted to be used up to 72 hours prior to start of study drugs.
  • Any investigational agent (whether for cancer treatment or not) less than 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study treatment. \< 6 weeks for mitomycin-C or nitrosourea.
  • Hematopoietic growth factor (granulocyte growth factor, erythropoiesis stimulating agent, thrombopoietin mimetic) or androgenic steroids less than 4 weeks before the first dose of study drug.
  • Participants with laboratory values at screening defined in Table 18.

About this study

To assess INCB05643 + ruxolitinib JAKi-naive patients with myelofibrosis

Read the detailed description

Primary Objective:

To evaluate splenic response rate by imaging after 24 weeks of treatment.

Secondary Objectives:

To evaluate splenic response rate by imaging after 24 weeks of treatment. To evaluate splenic response rate by imaging after 12 weeks of treatment To evaluate splenic response rate by imaging after 12 weeks of treatment To evaluate the overall splenic response rate and the duration of splenic response To evaluate the overall splenic response rate and the duration of splenic response To evaluate the proportion of patients who achieve both a splenic response and a ≥ 50% reduction in TSS after 24 weeks of treatment.

Conditions
Myelofibrosis
Being tested
Ruxolitinib, INCB57643
Medical subject headings
Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06619522
Study groupRoleWhat they receive
INCB+ RExperimentalNot described
Receives: Drug: Ruxolitinib; Drug: INCB57643

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Adverse Events (AEs). Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start11 Sep 2024
  3. Primary completion9 May 2025
  4. Study completion9 May 2025

Why it stopped: 0 participant accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06619522
Sponsor's protocol ID
2024-1031
Other IDs
NCI-2024-08192
Status last verified
May 2025
First submitted
25 Sep 2024
Last updated
22 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib and INCB57643 in people with Myelofibrosis, run by M.D. Anderson Cancer Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Adverse Events (AEs). Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06619522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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