Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
NCT04878003 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2022-05-09
Summary
This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF)
The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.
Conditions
- Primary Myelofibrosis (PMF)
- Post-Polycythemia Vera Myelofibrosis (Post-PV-MF)
- Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)
Interventions
- DRUG
-
KRT-232
KRT-232, administration by mouth
- DRUG
-
TL-895
TL-895, administration by mouth
Sponsors & Collaborators
-
Kartos Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-13
- Primary Completion
- 2024-05-31
- Completion
- 2025-10-31
- FDA Drug
- Yes
Countries
- United States
- Belarus
- Bulgaria
- Georgia
- Mexico
- Poland
- Russia
- South Africa
- Ukraine
Study Locations
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