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Clinical trial

A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis

ID
Name
IMG-7289-CTP-102
Description
This is a Phase 1/2 open-label study to evaluate the safety, tolerability, steady-state pharmacokinetic (PK) and pharmacodynamics (PD) of a lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat (IMG-7289/MK-3543), administered orally once daily in participants with myelofibrosis. The primary hypothesis is that bomedemstat is a safe and tolerable orally available agent when administered to participants with myelofibrosis including primary myelofibrosis (PMF), post-polycythaemia vera-myelofibrosis (PPVMF), and post-essential thrombocythaemia-myelofibrosis (PET-MF) (collectively referred to as 'MF'); inhibition of LSD1 by bomedemstat will reduce spleen size in those with splenomegaly, improve haematopoiesis and reduce constitutional symptoms associated with these disorders.
Trial arms
Trial start
2017-07-18
Estimated PCD
2022-03-08
Trial end
2022-03-08
Status
Completed
Phase
Early phase I
Treatment
Bomedemstat
Oral (capsule) administration according to dose allocation.
Arms:
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d, Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d, Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d, Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d, Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d, Ph 2b PMF: Bomedemstat 0.5 mg/kg/d, Ph 2b PMF: Bomedemstat 0.6 mg/kg/d, Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d, Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
Other names:
IMG-7289, MK-3543, LSD1 inhibitor
Size
90
Primary endpoint
Number of Participants With Dose Limiting Toxicities (DLTs)
Up to Day 7 of the ITP
Number of Participants With Serious Adverse Events
Up to approximately 30 months
Number of Participants With Adverse Events
Up to approximately 30 months
Number of Participants That Discontinued Study Treatment Due To AEs
Up to approximately 29 months
Phase 1/2a Portion: Observed Maximum Concentration (Cmax) of Bomedemstat
Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
Phase 1/2a Portion: Time to Maximum Concentration (Tmax) of Bomedemstat
Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
Phase 1/2a Portion: Area Under the Concentration-time Curve of Bomedemstat From Time 0 to 24 Hours Post-dose (AUC0-24)
Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
Phase 1/2a Portion: Apparent Total Clearance (CL/F) of Bomedemstat After Oral Administration
Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
Percentage Change From Baseline in Spleen Volume
Baseline, ITP Day 84 (Study Day 84), ITP Day 168 (Study Day 168), ATP1 Day 84 (Study Day 253), and ATP1 Day 168 (Study Day 337)
Percentage Change From Baseline in Spleen Size
Baseline, ITP Day 84 (Study Day 84), ITP Day 168 (Study Day 168), ATP1 Day 84 (Study Day 253), ATP1 Day 168 (Study Day 337), ATP2 Day 84 (Study Day 422), ATP2 Day 168 (Study Day 506), and ATP3 Day 84 (Study Day 591)
Eligibility criteria
Inclusion Criteria: * \>18 years of age * Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, or PPV-MF or PET-MF per the International Working Group for Myelofibrosis Research and Treatment * High or intermediate-2 risk disease Exclusion Criteria: * Receiving other treatments for the condition (with exceptions and time limits) * Major surgery in last 4 weeks, any surgery in the last 2 weeks * History of, or scheduled, hematopoietic stem cell transplant within 24 weeks of Screening * History of splenectomy * Current use of prohibited medications * A concurrent second active and nonstable malignancy * Known human immunodeficiency virus infection or active Hepatitis B or Hepatitis C virus infection * Other hematologic/biochemistry requirements, as per protocol * Use of an investigational agent within last 14 days * Pregnant or lactating females
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}
Updated at
2024-01-10

1 organization

1 product

4 indications

Organization
Imago BioSciences
Product
Bomedemstat
Indication
Myelofibrosis
Indication
Post-polycythemia Vera Myelofibrosis (PPV-MF)
Indication
Post-essential Thrombocythemia Myelofibrosis
Indication
Primary Myelofibrosis (PMF)