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Epigenetic Modulator

Bomedemstat for Myeloproliferative Disorders

Phase 2
Waitlist Available
Research Sponsored by Imago BioSciences,Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

Study Summary

This trial is assessing the long-term safety and effectiveness of a drug for patients with a specific type of blood cancer who participated in earlier studies of the drug.

Who is the study for?
This trial is for patients with myeloproliferative disorders who have already completed a treatment period in a previous bomedemstat study. They must be assessed by the investigator as suitable for continued dosing and agree to use contraception. Excluded are those on certain medications, unable to consent or comply, pregnant or breastfeeding women, participants in other trials, and anyone non-compliant in past studies.Check my eligibility
What is being tested?
The trial tests the long-term safety and effectiveness of an oral drug called bomedemstat (MK-3543) for people with blood disorders like primary myelofibrosis and essential thrombocythemia. It's an extension study for those who've been part of prior related research.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical concerns may include digestive issues, fatigue, liver function changes, bleeding problems due to platelet count alterations. Participants' experiences will vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Essential Thrombocythemia (ET) Participants Only: Change from Baseline in Platelet Counts
Myelofibrosis (MF) Participants Only: Change from Baseline in Spleen Volume
Number of Participants who Experience a Serious Adverse Event (SAE)
+3 more
Other outcome measures
Change from Baseline in Complete Blood Count (CBC)
Change from Baseline in Spleen Size
Change from Baseline in the Mutant (Variant) Allele Burden
+7 more

Side effects data

From 2022 Phase 1 & 2 trial • 90 Patients • NCT03136185
88%
Thrombocytopenia
63%
Nausea
50%
Oedema peripheral
38%
Pneumonia
38%
Diarrhoea
38%
Dysgeusia
25%
Pyrexia
25%
Pollakiuria
25%
Hot flush
25%
Fatigue
25%
Anaemia
25%
Constipation
25%
COVID-19
25%
Vomiting
25%
Hypoalbuminaemia
25%
Decreased appetite
25%
Muscular weakness
25%
Pain in extremity
25%
Myalgia
25%
Chronic obstructive pulmonary disease
25%
Epistaxis
25%
Hypotension
25%
Tachycardia
13%
Dry mouth
13%
Conjunctivitis
13%
Contusion
13%
Upper respiratory tract infection
13%
Cardiac murmur
13%
Hyperuricaemia
13%
Nephrolithiasis
13%
Pruritus
13%
Rash
13%
Small intestinal haemorrhage
13%
Rectal haemorrhage
13%
Influenza
13%
Neutropenia
13%
Septic shock
13%
Headache
13%
Dyspnoea
13%
Respiratory failure
13%
Ocular hyperaemia
13%
Bradycardia
13%
Lymphopenia
13%
Abdominal distension
13%
Abdominal pain
13%
Oral pain
13%
Erysipelas
13%
Fall
13%
Skin infection
13%
Blood alkaline phosphatase increased
13%
Activated partial thromboplastin time prolonged
13%
Parkinson's disease
13%
Blood lactate dehydrogenase increased
13%
Blood uric acid increased
13%
Blood sodium decreased
13%
Blood calcium decreased
13%
Blood potassium decreased
13%
Increased appetite
13%
Blood glucose increased
13%
Hypokalaemia
13%
Prothrombin time prolonged
13%
Hypophosphataemia
13%
Blood phosphorus decreased
13%
Weight decreased
13%
Paraesthesia
13%
Genital rash
13%
Muscle spasms
13%
Musculoskeletal pain
13%
Hypoxia
13%
Cough
13%
Rhinorrhoea
13%
Rash maculo-papular
13%
Decubitus ulcer
13%
Nail dystrophy
13%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d

Trial Design

1Treatment groups
Experimental Treatment
Group I: BomedemstatExperimental Treatment1 Intervention
Participants will receive bomedemstat daily for 169 days with additional treatment continuing in participants deriving clinical benefit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bomedemstat
2017
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Imago BioSciences,Inc.Lead Sponsor
9 Previous Clinical Trials
364 Total Patients Enrolled
2 Trials studying Primary Myelofibrosis
130 Patients Enrolled for Primary Myelofibrosis
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)Lead Sponsor
9 Previous Clinical Trials
364 Total Patients Enrolled
2 Trials studying Primary Myelofibrosis
130 Patients Enrolled for Primary Myelofibrosis
Hugh Rienhoff, MDStudy DirectorImago BioSciences
2 Previous Clinical Trials
93 Total Patients Enrolled

Media Library

Bomedemstat (Epigenetic Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05223920 — Phase 2
Primary Myelofibrosis Research Study Groups: Bomedemstat
Primary Myelofibrosis Clinical Trial 2023: Bomedemstat Highlights & Side Effects. Trial Name: NCT05223920 — Phase 2
Bomedemstat (Epigenetic Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05223920 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widely dispersed is the implementation of this clinical trial within North America?

"The Fred Hutchinson Cancer Center in Seattle, Washington, University of Miami Leonard M. Miller in Miami, Florida and the University of Michigan in Ann Arbor, Michigan are a few of the sites conducting this medical trial alongside 5 additional places."

Answered by AI

Are applications for participation in this clinical trial currently being accepted?

"According to clinicaltrials.gov, this particular study is not currently enrolling patients; the original post was made on December 16th 2021 and last edited November 22nd 2022. Despite this lack of recruitment for this trial, there are 2524 other medical trials actively recruiting participants at present."

Answered by AI

What potential perils are associated with administering Bomedemstat?

"Our research team has assigned a score of 2 to Bomedemstat's safety profile, due to the lack of evidence regarding its efficacy but presence of data confirming security."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
University of Miami Leonard M. Miller
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)
2021. "Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05223920.
All > Essential Thrombocythemia > Myelofibrosis
~7 spots leftby Aug 2024
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