Study on the Safety and Effectiveness of KRT-232 with Ruxolitinib for Myelofibrosis Patients with Limited Response to Ruxolitinib

Sponsor: Kartos Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04485260

Provider View

This clinical trial is testing a new treatment combination of KRT-232 and ruxolitinib for patients with different types of myelofibrosis who have not responded well to ruxolitinib alone after at least 18 weeks of treatment.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining KRT-232 with ruxolitinib is safe and effective for patients with myelofibrosis who have not had a good response to ruxolitinib after 18 weeks. The main goal is to determine the best dose of KRT-232 to use with ruxolitinib for future studies.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.
  • Have been treated with ruxolitinib for at least 18 weeks before joining the study and have been on a stable dose for the last 8 weeks.
  • Have an enlarged spleen that is at least 5 cm below the rib cage or measures 450 cm³ or more by MRI or CT scan.
  • Experience at least two symptoms related to myelofibrosis with a score of at least 1 on a specific symptom assessment form.
  • Have an ECOG performance status score between 0 and 2, indicating full activity or some restriction in physically strenuous activity.

Exclusion Criteria

  • Have a positive test for TP53 mutations.
  • Have shown disease progression or worsening symptoms while on ruxolitinib treatment.
  • Have had a reduction in spleen size in response to ruxolitinib.
  • Have had spleen removal surgery.
  • Have previously received MDM2 inhibitor therapy or treatments targeting the p53 protein.

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