Trial Title:
A Study of Bomedemstat (MK-3543) in Participants With Polycythemia Vera (MK-3543-004)
NCT ID:
NCT05558696
Condition:
Polycythemia Vera
Conditions: Official terms:
Polycythemia Vera
Polycythemia
Conditions: Keywords:
polycythemia vera
bomedemstat
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bomedemstat
Description:
Oral tablet
Arm group label:
Bomedemstat
Other name:
MK-3543
Other name:
IMG-7289
Summary:
This study will evaluate the safety, efficacy, pharmacokinetics (PK), and
pharmacodynamics of the orally administered lysine-specific demethylase 1 (LSD1)
inhibitor bomedemstat, in participants with polycythemia vera (PV). At Week 36 of dosing,
participants will be assessed for eligibility to receive additional treatment through
Week 52. Participants deriving clinical benefit and safely tolerating bomedemstat will
qualify for continued treatment at the Investigator's discretion.
Detailed description:
With Amendment 3, after all ongoing participants have reached 52 weeks of treatment,
eligible participants may transition to a bomedemstat extension study if available. With
Amendment 4, all secondary PK and patient reported outcome measures were designated as
exploratory.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Has a diagnosis of Polycythemia Vera per World Health Organization (WHO) diagnostic
criteria for myeloproliferative neoplasms
- Has a bone marrow fibrosis score of Grade 0 or Grade 1
- Has failed at least one standard cytoreductive therapy to lower hematocrit
- Has a life expectancy >36 weeks
- Has discontinued prior cytoreductive therapy for 2 weeks (4 weeks for interferon)
prior to study drug initiation
Exclusion Criteria:
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater
- Has unresolved treatment related toxicities from prior therapies (unless resolved to
≤ Grade 1)
- Has an uncontrolled active infection
- Has a known human immunodeficiency virus (HIV) infection or active Hepatitis B or
Hepatitis C virus infection
- Has evidence of increased risk of bleeding, including known bleeding disorders
- Is pregnant or lactating
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
BRCR Global ( Site 0120)
Address:
City:
Plantation
Zip:
33322
Country:
United States
Facility:
Name:
Hematology Oncology of the North Shore ( Site 0104)
Address:
City:
Skokie
Zip:
60076-1264
Country:
United States
Facility:
Name:
University of Michigan Comprehensive Cancer Center ( Site 0008)
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Peak ( Site 0118)
Address:
City:
Las Vegas
Zip:
89128
Country:
United States
Facility:
Name:
Duke University Medical Center ( Site 0016)
Address:
City:
Durham
Zip:
27705
Country:
United States
Facility:
Name:
Ohio State University Comprehensive Cancer Center ( Site 0103)
Address:
City:
Columbus
Zip:
43203
Country:
United States
Facility:
Name:
OHSU Knight Cardiovascular Institute Cardiology Clinic - South Waterfront ( Site 0102)
Address:
City:
Portland
Zip:
97239-4503
Country:
United States
Facility:
Name:
Huntsman Cancer Hospital at the University of Utah ( Site 0119)
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Facility:
Name:
Sunshine Coast Hematology and Oncology Clinic (Site 0506)
Address:
City:
Sunshine Coast
Zip:
4556
Country:
Australia
Facility:
Name:
Monash Medical Centre ( Site 0006)
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Facility:
Name:
Royal Perth Hospital ( Site 0504)
Address:
City:
Perth
Zip:
6000
Country:
Australia
Facility:
Name:
Gloucestershire Royal Hospital ( Site 0205)
Address:
City:
Gloucester
Zip:
GL1 3NN
Country:
United Kingdom
Facility:
Name:
United Lincolnshire Hospitals NHS Trust ( Site 0204)
Address:
City:
Lincoln
Zip:
LN2 5QY
Country:
United Kingdom
Facility:
Name:
Imperial College London ( Site 0025)
Address:
City:
London
Zip:
W12 0HS
Country:
United Kingdom
Facility:
Name:
Boston Pilgrim Hospital ( Site 0207)
Address:
City:
Boston
Zip:
PE21 9QS
Country:
United Kingdom
Facility:
Name:
Guys and St Thomas NHS Foundation Trust - Guys Hospital ( Site 0020)
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Facility:
Name:
Royal Gwent Hospital ( Site 0201)
Address:
City:
Newport
Zip:
NP9 2UB
Country:
United Kingdom
Start date:
September 7, 2023
Completion date:
March 24, 2025
Lead sponsor:
Agency:
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Agency class:
Industry
Source:
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05558696
https://www.merckclinicaltrials.com/
