Clinical trial

A Multi-Center, Open Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Patients With Myeloproliferative Neoplasms (MPNs) Enrolled in a Prior Bomedemstat Clinical Study

Name

IMG-7289-CTP-202

Description

This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat (MK-3543, formerly called IMG-7289) administered orally once daily in participants with an MPN who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102 and IMG-7289-CTP-201 (referred to hereafter as 'feeder studies').

Trial arms

Trial start

2021-12-16

Estimated PCD

2024-08-22

Trial end

2024-08-22

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Bomedemstat

Capsule (oral)

Arms:

Bomedemstat

Other names:

IMG-7289, MK-3543

Size

Primary endpoint

Number of Participants who Experience an Adverse Event (AE)

Up to approximately 3 years

Number of Participants who Experience a Serious Adverse Event (SAE)

Up to approximately 3 years

Number of Participants with Clinically Significant Change from Baseline in One or More Vital Signs

Baseline and up to approximately 3 years

Number of Participants with Clinically Significant Changes from Baseline in One or More Laboratory Parameters

Baseline and up to approximately 3 years

Myelofibrosis (MF) Participants Only: Change from Baseline in Spleen Volume

Baseline and up to approximately 3 years

Essential Thrombocythemia (ET) Participants Only: Change from Baseline in Platelet Counts

Baseline and up to approximately 3 years

Eligibility criteria

Inclusion Criteria: 1. Completed at least one Treatment Period (TP) in a prior bomedemstat MPN protocol (such as, but not limited to, IMG-7289-CTP-102 or IMG-7289-CTP-201). 2. In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat. Exclusion Criteria: 1. Ongoing participation in another investigational study (except observational studies). 2. A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted). 3. Current use of a prohibited medication (e.g., romiplostim). 4. Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol. 5. Females who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study. 6. Women of childbearing potential (WOCBP) and fertile men unwilling to agree to use an approved method of contraception from time of enrollment until 14 days after last bomedemstat dose.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2024-03-22

1 organization

1 product

3 indications

Product

Bomedemstat

Indication

Thrombocythemia

Indication

Essential

Indication

Primary Myelofibrosis

Organization

Imago BioSciences