KRT-232 for Myelofibrosis
(BOREAS Trial)
Trial Summary
What is the purpose of this trial?
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug KRT-232 for Myelofibrosis?
What safety data exists for KRT-232 (Navtemadlin) in humans?
Navtemadlin, also known as KRT-232, has been studied for its safety in humans, particularly in the context of myelofibrosis and other conditions. While specific safety data for KRT-232 is not detailed in the provided research, it is mentioned alongside other novel therapies being developed for myelofibrosis, suggesting ongoing evaluation of its safety profile.16789
How is the drug KRT-232 (Navtemadlin) different from other treatments for myelofibrosis?
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 2 Treatment
Phase 2 will determine the KRT-232 recommended dose and dosing schedule
Phase 3 Treatment
Phase 3 will test KRT-232 vs Best Available Therapy (BAT) with an option to cross-over to KRT-232 after 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Best Available Therapy (BAT)
- KRT-232
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kartos Therapeutics, Inc.
Lead Sponsor