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RecruitingLast updated: 7 February 2024

(BOREAS: This phase II trial is evaluating an oral drug (KRT-232) for the treatment of patients with myelofibrosis who are no longer benefiting their current treatment with a JAK inhibitorAn Open-Label, Phase 2a/2b Study of KRT-232 in Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post-ET-MF) Who Have Failed a JAK Inhibitor

Clinical summary

Summary

Eligible patients will be randomised to receive varying doses of KRT-232 across either a 21-day or 28-day treatment cycle, depending on their group assignment.

Conditions

This trial is treating patients with Primary Myelofibrosis, Post-Polycythemia Vera or Post-Essential Thrombocythemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

(BOREAS

More information

Trial Identifiers

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Trial sponsor

Kartos Therapeutics, Inc.

Scientific Title

An Open-Label, Phase 2a/2b Study of KRT-232 in Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post-ET-MF) Who Have Failed a JAK Inhibitor

Eligibility

Inclusion

  • Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
  • High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
  • Failure of prior treatment with JAK inhibitor
  • ECOG ≤ 2

Exclusion

  • Prior splenectomy
  • Splenic irradiation within 3 months prior to randomization
  • History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization
  • History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization
  • Prior MDM2 inhibitor therapy or p53-directed therapy
  • Prior allogeneic stem-cell transplant or plans for allogeneic stem cell transplant
  • History of major organ transplant
  • Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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