KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment
Status unconfirmed · Phase 2/Phase 3
Conditions studied: Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Post-Essential Thrombocythemia MF (Post-ET-MF)
In brief
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.
Key facts
- Study ID
- NCT03662126
- Run by
- Kartos Therapeutics, Inc.
- People needed
- 385
- Starts
- 2019-01-15
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2023-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Centro de oncologia Leonardo da Vinci — Fortaleza, Ceará, Brazil (enrolling)
- Fundacao Doutor Amaral Carvalho — Jaú, Brazil (enrolling)
- The Alfred Hospital — Melbourne, Australia (enrolling)
- Icon Cancer Center — South Brisbane, Australia (enrolling)
- Hospital Erasto Gaertner — Curitiba, Paraná, Brazil (enrolling)
- Hospital das Clínicas UFG — Goiânia, Brazil (enrolling)
- Royal Adelaide Hospital — Adelaide, Australia (enrolling)
- Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
- Brookdale University Hospital and Medical Center — Brooklyn, New York, United States (enrolling)
- South Eastern Private Hospital — Noble Park, Australia (enrolling)
- Mt. Sinai — New York, New York, United States (enrolling)
- Gabrail Cancer Center — Canton, Ohio, United States (enrolling)
- University of Illinois at Chicago — Chicago, Illinois, United States (enrolling)
- UNICAMP - Universidade Estadual de Campinas Hemocentro — Campinas, São Paulo, Brazil (enrolling)
- Avera Cancer Institute — Sioux Falls, South Dakota, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Medical College of Wisconsin - Froedtert Hospital — Milwaukee, Wisconsin, United States (enrolling)
- Sanatorio de la Mujer — Rosario, Santa Fe Province, Argentina (enrolling)
- Instituto Medico Alexander Fleming — Buenos Aires, Argentina (enrolling)
- Centro Medico San Luis — CABA, Argentina (enrolling)
- Hospital Privado - Centro Medico de Cordoba - Oncology — Córdoba, Argentina (enrolling)
- Monash Medical Centre — Clayton, Victoria, Australia (enrolling)
- Fiona Stanley Hosital — Murdoch, Western Australia, Australia (enrolling)
- Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica — Porto Alegre, Brazil (enrolling)
Full record on ClinicalTrials.gov
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