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KRT-232 for Myelofibrosis (BOREAS Trial)
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.
BOREAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBOREAS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BOREAS Trial Design
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Who is running the clinical trial?
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- 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.
- 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
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Do we have any precedent for using KRT-232 in this way?
"KRT-232 was first researched in 2017 at Huntsman Cancer Institute/University of Utah. There have been 7 completed clinical trials and 13 more are ongoing, with a significant portion taking place in New Haven, Connecticut."
Are investigators still looking for new participants in this research study?
"This clinical trial, which was first posted on January 15th 2019, is currently seeking patients, as reported on clinicaltrials.gov."
At how many different locations can people participate in this research?
"Currently, this study has 16 enrolment sites which are actively recruiting patients. These locations include Yale University in New Haven, Tom Baker Cancer Center in Calgary, Summit Medical Group in Florham Park, and other centres across the globe."
How many people are currently enrolled in this clinical trial?
"In order to move forward with this study, we need 385 individuals that fit the specified bill. These people can come from multiple places, such as Yale University and Tom Baker Cancer Center."
What is the goal of this research?
"The primary goals of this 24-week study are to observe a reduction in spleen volume (SVR) and, separately, an improvement the total symptom score (TSS). TSS will be measured by the modified MPN-SAF v2.0 over the course of 48 weeks while SVR is only being evaluated during Part B of the trial. Additionally, researchers want to track the rate at which patients become RBC transfusion independent as well as general overall survival rates."
Who else is applying?
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