Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003)

Essential Thrombocythemia Clinical Trial

Official title:

A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy and Pharmacodynamics of IMG-7289 in Patients With Essential Thrombocythemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254978
• Other study ID #: IMG-7289-CTP-201
• Secondary ID: MK-3543-0032019-
• Status: Completed
• Phase: Phase 2
• Start date: September 8, 2020
• Est. completion date: March 23, 2023

Study information

• Verified date: March 2024
• Source: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, Bomedemstat (MK-3543, formerly called IMG-7289), in patients with essential thrombocythemia.

This study investigates the following:

• The safety and tolerability of Bomedemstat

• The pharmacodynamic effect of Bomedemstat

Description:

This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy and pharmacodynamics of Bomedemstat administered orally once daily in patients with essential thrombocythemia (ET). Patients will be dosed with Bomedemstat for 169 consecutive days in the Initial Treatment Period (ITP). Qualifying patients may continue to receive Bomedemstat in the Additional Treatment Period (ATP).

Safety will be evaluated by clinical assessments of safety parameters i.e., safety laboratory testing, adverse event reporting, physical examination and vital sign assessments. Pharmacodynamics will be evaluated by hematology assessment, patient reported symptom burden, change in spleen size by palpation and other measures.

To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms.

• Requires treatment in order to lower platelet count based on patient age over 60 or history of thrombosis.

• Have failed at least one standard therapy

• Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to study drug initiation.

Exclusion Criteria:

• Has undergone major surgery =4 weeks prior to starting study drug or has not recovered from side effects of such surgery.

• Unresolved treatment related toxicities from prior therapies (unless resolved to = Grade 1).

• Uncontrolled active infection.

• Current use of prohibited medications

• Known HIV infection or active Hepatitis B or Hepatitis C virus infection

• Other hematologic/biochemistry requirements, as per protocol

• Use of investigational agent within last 14 days

• Pregnant or lactating females

Related Conditions & MeSH terms

• Essential Thrombocythemia
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

Drug:
• Bomedemstat
Oral administration

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Clayton	Victoria
Australia	Local Institution	Herston	Brisbane
Australia	Local Institution	Southport	Queensland
Australia	Local Institution	St Leonards	New South Wales
Germany	Department of Hematology and Stem Cell Transplantation, West German Cancer Center (WTZ)	Essen
Germany	Local Institution	Jena
Hong Kong	Local Institution	Hong Kong
Italy	Local Institution	Alessandria
Italy	Local Institution	Bologna
Italy	CRIMM; Centro Ricerca e Innovazione delle Malattia Mieloproliferative, Azienda ospedaliera Universitaria Careggi	Florence
Italy	Local Institution	Varese
New Zealand	Local Institution	Auckland
New Zealand	Middlemore Hospital	Auckland
United Kingdom	Guys and St Thomas Hospital	London
United Kingdom	Local Institution	London
United Kingdom	Local Institution	London
United Kingdom	Local Institution	Oxford
United States	Local Institution	Ann Arbor	Michigan
United States	Cleveland Clinic	Cleveland	Ohio
United States	Local Institution	Durham	North Carolina
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	New York	New York
United States	Local Institution	Pittsburgh	Pennsylvania
United States	Local Institution	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Hong Kong,  Italy,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced an Adverse Event (AE)	An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during the study, in conjunction with the use of the drug or biologic, whether or not product related. This includes any untoward signs or symptoms experienced by the participant from the time of first dose with study treatment until completion of the study. The number of participants who experienced an AE is reported.	Up to approximately 30 months
Primary	Number of Participants Who Discontinued Study Treatment Due to an AE	An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in the study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with study treatment until completion of the study. The number of participants who discontinued study treatment due to an AE is reported.	Up to approximately 28 months
Primary	Percentage of Participants With Platelet Count =400 k/µL at Day 169	Blood samples were collected at pre-specified timepoints to determine platelet counts. The percentage of participants who achieved reduction in platelet count to =400k/µL in the absence of new thrombolytic events is reported.	Up to day 169

External Links

•   Merck Clinical Trials Information