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LSD1 Inhibitor
Bomedemstat for Polycythemia Vera
Phase 2
Waitlist Available
Research Sponsored by Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
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 at designated time points on day 1, day 15 and at investigators choice of one of any regularly scheduled study visit from week 4 (day 29) to week 8 (day 57)
Awards & highlights
Study Summary
This trial studies an oral drug to treat a blood disorder. It will look at safety and how it affects the body.
Who is the study for?
This trial is for people with Polycythemia Vera who haven't responded well to at least one standard treatment. They should have a certain level of platelets and white blood cells, expect to live more than 36 weeks, and meet specific diagnostic criteria. Those with severe physical limitations, unresolved side effects from past treatments, certain infections or bleeding risks, pregnant or breastfeeding women, or on prohibited meds can't join.Check my eligibility
What is being tested?
The study tests Bomedemstat (MK-3543), an oral drug that targets LSD1 enzymes in patients with Polycythemia Vera. The goal is to see if it's safe and can manage the disease by reducing blood counts, improving symptoms, and shrinking enlarged spleens within 36 weeks.See study design
What are the potential side effects?
While the exact side effects are not listed here, typical reactions may include issues related to digestion due to oral intake of medication; potential impact on blood counts since it targets hematologic response; fatigue as commonly seen in such treatments; and possibly liver enzyme changes given its metabolic pathway.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at designated time points on day 1, day 15 and at investigators choice of one of any regularly scheduled study visit from week 4 (day 29) to week 8 (day 57)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at designated time points on day 1, day 15 and at investigators choice of one of any regularly scheduled study visit from week 4 (day 29) to week 8 (day 57)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who discontinued study intervention due to AEs
Number of participants with adverse events (AEs)
Number of participants with change from baseline of hematocrit to <45% without phlebotomy at Week 36
Secondary outcome measures
Area under the curve 0-24 (AUC 0-24) of bomedemstat
Duration of platelet count ≤ 450 x 10^9/L in participants at Week 36
Duration of reduction of hematocrit to <45% without phlebotomy
+12 moreSide effects data
From 2018 Phase 1 & 2 trial • 45 Patients • NCT02842827100%
Diarrhoea
50%
Epistaxis
50%
Hypophosphataemia
50%
Hypotension
50%
Nausea
50%
Hypokalaemia
50%
Conjunctivitis
25%
Pyrexia
25%
Hypomagnesaemia
25%
Confusional state
25%
Acute pulmonary oedema
25%
Vomiting
25%
Dyspnoea
25%
Cellulitis
25%
Lower respiratory tract infection bacterial
25%
Pneumonia
25%
Anaemia
25%
Thrombocytopenia
25%
Conjunctival hyperaemia
25%
Eye haemorrhage
25%
Eye pain
25%
Eye swelling
25%
Gastrooesophageal reflux disease
25%
Chest pain
25%
Pain
25%
Thirst
25%
Subcutaneous haematoma
25%
Decreased appetite
25%
Fluid overload
25%
Hypoglycaemia
25%
Arthralgia
25%
Depressed level of consciousness
25%
Dysgeusia
25%
Multiple organ dysfunction syndrome
25%
Hypoxia
25%
Tachypnoea
25%
Skin lesion
25%
Otitis externa
25%
Lower respiratory tract infection fungal
25%
Hypertension
25%
Oedema
25%
Hordeolum
25%
Haematuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day
Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day
Cohort 1a: Bomedemstat 0.75 mg/kg/Day
Cohort 1b: Bomedemstat 1.5 mg/kg/Day
Cohort 1c: Bomedemstat 3 mg/kg/Day
Cohort 1d: Bomedemstat 6 mg/kg/Day
Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day
Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day
Trial Design
1Treatment groups
Experimental Treatment
Group I: bomedemstatExperimental Treatment1 Intervention
Participants will receive bomedemstat daily for 36 weeks and may qualify for additional treatment thereafter if deriving clinical benefit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bomedemstat
2016
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)Lead Sponsor
9 Previous Clinical Trials
424 Total Patients Enrolled
2 Trials studying Polycythemia Vera
114 Patients Enrolled for Polycythemia Vera
Imago BioSciences,Inc.Lead Sponsor
9 Previous Clinical Trials
424 Total Patients Enrolled
2 Trials studying Polycythemia Vera
114 Patients Enrolled for Polycythemia Vera
Hugh Rienhoff, MDStudy DirectorImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
2 Previous Clinical Trials
153 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bone marrow fibrosis is minimal.I have HIV or active Hepatitis B/C.I have tried at least one standard treatment to lower my blood volume without success.I stopped my previous cancer treatment 2 weeks ago, or 4 weeks ago if it was interferon.I have an ongoing infection that isn't under control.I need considerable assistance and am unable to care for myself.I have a condition that increases my risk of bleeding.My side effects from previous treatments are mild or gone.I have been diagnosed with Polycythemia Vera according to WHO standards.You are expected to live for at least 36 more weeks.
Research Study Groups:
This trial has the following groups:- Group 1: bomedemstat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has bomedemstat received endorsement from the Federal Drug Administration?
"Taking into consideration the Phase 2 status of bomedemstat, our team at Power assigned it a safety rating of two due to limited data supporting efficacy."
Answered by AI
What is the aggregate amount of individuals involved in this research?
"Affirmative. Information accessed from clinicaltrials.gov attests that this research protocol, which was first unveiled on February 1st 2023, is currently inviting participants to join the study. A total of 20 volunteers are expected to be recruited from a single medical centre."
Answered by AI
Is participation in this clinical trial currently available for persons seeking treatment?
"According to the listing on clinicaltrials.gov, this investigation is currently accepting volunteers; initial posting was February 1st 2023 with the most recent update being made on February 3rd of that same year."
Answered by AI
What is the ultimate objective of this research endeavor?
"Within the 14-day period assessed, this clinical trial is primarily assessing the percentage of patients that experience a decrease in hematocrit. Supporting data will be collected to evaluate the duration of this change, spleen volume reduction and Cmax with sparse blood sampling for bomedemstat pharmacokinetics."
Answered by AI
Who else is applying?
What site did they apply to?
Duke University Medical Center ( Site 0016)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I have a JAK2 gene that isn't working. I currently take 1500 mg of Hydroxyurea.
PatientReceived 2+ prior treatments
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