Trials / Unknown
UnknownNCT03662126
KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment
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
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 385 (estimated)
- Sponsor
- Kartos Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Primary Myelofibrosis (PMF)
- Post-Polycythemia Vera MF (Post-PV-MF)
- Post-Essential Thrombocythemia MF (Post-ET-MF)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KRT-232 | KRT-232, administered by mouth |
| DRUG | Best Available Therapy (BAT) | Best available therapy options include: 1. hydroxyurea 2. chemotherapy or 3. supportive care (including but not limited to corticosteroids and androgens; JAK inhibitors not allowed). |
Timeline
- Start date
- 2019-01-15
- Primary completion
- 2023-12-31
- Completion
- 2025-12-31
- First posted
- 2018-09-07
- Last updated
- 2023-04-28
Locations
191 sites across 28 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Croatia, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Lithuania, Mexico, Philippines, Poland, Portugal, Romania, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03662126. Inclusion in this directory is not an endorsement.