©2024 Stanford Medicine
KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment
Recruiting
I'm InterestedTrial ID: NCT03662126
Purpose
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.
Official Title
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
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)
Intervention(s):
drug: KRT-232
drug: Best Available Therapy (BAT)
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Justin Abuel
6507231367