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KRT-232 for Myelofibrosis (BOREAS Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Kartos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
Must not have
Prior MDM2 inhibitor therapy or p53-directed therapy
Prior allogeneic stem-cell transplant or plans for allogeneic stem cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study KRT-232, a new drug that inhibits MDM2, for the treatment of patients with myelofibrosis who are no longer benefiting from treatment with a JAK inhibitor. The trial will be conducted in 2 phases.

Who is the study for?
This trial is for patients with myelofibrosis who haven't responded to JAK inhibitor treatment. They should have a performance status score of 2 or less, indicating they can perform daily activities with some effort. The trial excludes those with significant heart issues, recent major organ transplants, brain injuries or strokes within the past 6 months, prior splenectomy, and previous treatments targeting MDM2 or p53.
What is being tested?
The study tests KRT-232 against Best Available Therapy (BAT) in myelofibrosis patients unresponsive to JAK inhibitors. Phase 2 determines the optimal dose of KRT-232; Phase 3 compares its effectiveness to BAT chosen by physicians. Participants are randomly assigned in a 2:1 ratio favoring KRT-232 and may switch from BAT to KRT-232 if needed.
What are the potential side effects?
While specific side effects for KRT-232 aren't listed here, similar drugs often cause fatigue, nausea, diarrhea, liver function changes and potential blood cell count alterations. Side effects vary based on individual health conditions and drug interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a form of myelofibrosis.
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My condition is classified as high, intermediate-2, or intermediate-1 risk.
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I have been treated with a JAK inhibitor, but it did not work for me.
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I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously received MDM2 or p53-targeted therapy.
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I have had or plan to have a stem cell transplant from a donor.
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I have had my spleen removed.
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I have not had radiation to my spleen in the last 3 months.
Select...
I have had a major organ transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
(Part A Only) Spleen Volume Reduction (SVR)
(Part B Only) Spleen Volume Reduction (SVR)
Secondary study objectives
(Part A only) Improvement in Total Symptom Score (TSS)
Spleen
Blood Transfusion
+4 more

Awards & Highlights

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

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Part B Arm 1 KRT-232Experimental Treatment1 Intervention
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)
Group II: Part A Cohort 4bExperimental Treatment1 Intervention
KRT-232 240 mg by mouth once daily for Days 1-5, off treatment for Days 6-28 (28-day cycles)
Group III: Part A Cohort 3Experimental Treatment1 Intervention
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)
Group IV: Part A Cohort 2Experimental Treatment1 Intervention
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Group V: Part A Cohort 1Experimental Treatment1 Intervention
KRT-232 120 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Group VI: Part B Arm 2 Best Available TherapyActive Control1 Intervention
Best available therapy at the discretion of the investigator, on a 28-day cycle.

Find a Location

Who is running the clinical trial?

Kartos Therapeutics, Inc.Lead Sponsor
16 Previous Clinical Trials
1,665 Total Patients Enrolled

Media Library

Best Available Therapy (BAT) Clinical Trial Eligibility Overview. Trial Name: NCT03662126 — Phase 2 & 3
Myelofibrosis Research Study Groups: Part A Cohort 2, Part A Cohort 4b, Part B Arm 2 Best Available Therapy, Part B Arm 1 KRT-232, Part A Cohort 1, Part A Cohort 3
Myelofibrosis Clinical Trial 2023: Best Available Therapy (BAT) Highlights & Side Effects. Trial Name: NCT03662126 — Phase 2 & 3
Best Available Therapy (BAT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03662126 — Phase 2 & 3
~56 spots leftby Dec 2025
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