Study Comparing KRT-232 to Best Available Therapy for Treating Myelofibrosis in Patients Who No Longer Respond to JAK Inhibitors

Sponsor: Kartos Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03662126

Provider View

This clinical trial is testing a new oral medication, KRT-232, for patients with myelofibrosis who have stopped benefiting from JAK inhibitor treatments. The study will compare KRT-232 to other available treatments to see which is more effective.

Patient Parameters

Program Overview

The study is exploring a new treatment option, KRT-232, for patients with myelofibrosis (MF) who no longer respond to JAK inhibitors. KRT-232 works by blocking a protein called MDM2, which is a new approach to treating MF. The study has two parts: Phase 2 will find the best dose and schedule for KRT-232, and Phase 3 will compare KRT-232 to the best available therapy (BAT). In Phase 3, patients will be randomly assigned to receive either KRT-232 or BAT, with the option to switch to KRT-232 if their condition worsens or after 6 months on BAT.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF).
  • Classified as high, intermediate-2, or intermediate-1 risk according to the Dynamic International Prognostic System (DIPSS).
  • Have not responded to previous treatment with a JAK inhibitor.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, indicating they are fully active or able to carry out light work.

Exclusion Criteria

  • Have had a spleen removal surgery.
  • Have received radiation treatment to the spleen within the last 3 months.
  • Have had a major bleeding event or brain bleed in the last 6 months.
  • Have had a stroke or temporary reduction in blood flow to the brain in the last 6 months.
  • Have previously been treated with an MDM2 inhibitor or p53-directed therapy.
  • Have had a stem cell transplant or plan to have one.
  • Have had a major organ transplant.
  • Have a heart rhythm problem with a QTc interval greater than 480 milliseconds.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.