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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
BOREAS Trial 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.Check my eligibility
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.See study design
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.
BOREAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
BOREAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
(Part A Only) Spleen Volume Reduction (SVR)
(Part B Only) Spleen Volume Reduction (SVR)
Secondary outcome measures
(Part A only) Improvement in Total Symptom Score (TSS)
Spleen
Blood Transfusion
+4 moreBOREAS 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.
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Who is running the clinical trial?
Kartos Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
1,065 Total Patients Enrolled
3 Trials studying Primary Myelofibrosis
204 Patients Enrolled for Primary Myelofibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously received MDM2 or p53-targeted therapy.I have had or plan to have a stem cell transplant from a donor.I have had my spleen removed.I have not had any major bleeding or brain bleeding in the last 6 months.I have not had a stroke or temporary paralysis in the last 6 months.I have been diagnosed with a form of myelofibrosis.My condition is classified as high, intermediate-2, or intermediate-1 risk.I have been treated with a JAK inhibitor, but it did not work for me.I can take care of myself and am up and about more than 50% of my waking hours.I have not had radiation to my spleen in the last 3 months.I have had a major organ transplant.My previous treatment with a JAK inhibitor did not work and I can still care for myself.
Research Study Groups:
This trial has the following groups:- Group 1: Part A Cohort 2
- Group 2: Part A Cohort 4b
- Group 3: Part B Arm 2 Best Available Therapy
- Group 4: Part B Arm 1 KRT-232
- Group 5: Part A Cohort 1
- Group 6: Part A Cohort 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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