Status:
UNKNOWN
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib
Lead Sponsor:
Kartos Therapeutics, Inc.
Conditions:
Myelofibrosis
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the s...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO)
- Treatment with ruxolitinib for ≥18 weeks prior to study entry, and on a stable dose of ruxolitinib in the 8 weeks prior to study entry
- Spleen ≥5 cm palpable below the LLCM or ≥450 cm3 by MRI or CT
- Patients must have at least 2 symptoms with a score of at least 1 on the MFSAF v4.0
- ECOG performance status of 0 to 2
Exclusion
- Patients who are positive for TP53 mutations
- Documented disease progression or clinical deterioration any time while on ruxolitinib treatment
- Patients who have had a documented spleen response to ruxolitinib.
- Prior splenectomy
- Prior MDM2 inhibitor therapy or p53-directed therapy
Key Trial Info
Start Date :
January 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04485260
Start Date
January 28 2021
End Date
October 1 2024
Last Update
May 9 2022
Active Locations (38)
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1
City of Hope
Duarte, California, United States, 91010
2
John Hopkins University
Baltimore, Maryland, United States, 21205
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029