Clinical Trials Search at Vanderbilt-Ingram Cancer Center
KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment
Multiple Cancer Types
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.
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.
Hematologic,
Leukemia
II
Savona, Michael
NCT03662126
VICCHEM18136
