Study #2018-0906
A Phase 2/3 Randomized, Controlled, Open-Label Study ofKRT-232 in Subjects with Primary Myelofibrosis (PMF),Post-Polycythemia Vera MF (Post-PV-MF), Or Post-EssentialThrombocythemia MF (Post-ET-MF) who are Relapsed orRefractory to Janus Kinase (JAK
MD Anderson Study Status
Enrolling
Treatment Agent
KRT-232, Best Available Therapy (BAT)
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.
Information and next steps
Disease:
Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Post-Essential Thrombocythemia MF (Post-ET-MF)
Study phase:
II/III
Physician name:
Prithviraj Bose
Department:
Leukemia
For general questions about clinical trials:
1-877-632-6789
Help #EndCancer
Give Now
Donate Blood
Due to our response to COVID-19, all blood donations at MD Anderson
Blood Donor Center locations are being held by appointment only.