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A Phase 2/3 Randomized, Controlled, Open-Label 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 Are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment
Description
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.
Trial Eligibility
Inclusion Criteria: * 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 Criteria: * 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)
Study Info
Organization
Kartos Therapeutics, Inc.
Primary Outcome
(Part A Only) Spleen Volume Reduction (SVR)
Interventions
Locations Recruiting
The Kirklin Clinic of UAB Hospital
United States, Alabama, Birmingham
University of Southern California Norris Comprehensive Cancer Center
United States, California, Los Angeles
Stanford Cancer Center - Palo Alto
United States, California, Stanford
Innovative Clinical Research Institute
United States, California, Whittier
University Cancer Institute
United States, Florida, Boynton Beach
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