Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)
- Conditions
- Thrombocythemia, EssentialPrimary Myelofibrosis
- Interventions
- Registration Number
- NCT05223920
- Lead Sponsor
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
- Brief Summary
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').
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Completed at least one Treatment Period (TP) in a prior bomedemstat Myeloproliferative Neoplasm (MPN) protocol (such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 or IMG-7289-CTP-201/MK-3543-003).
- In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.
- Ongoing participation in another investigational study (except observational studies).
- A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted).
- Current use of a prohibited medication (e.g., romiplostim).
- 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.
- Females who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bomedemstat Bomedemstat Participants will receive bomedemstat daily for 169 days with additional treatment continuing in participants deriving clinical benefit.
- Primary Outcome Measures
Name Time Method Number of Participants who Experience an Adverse Event (AE) Up to approximately 3 years An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study.
Number of Participants who Experience a Serious Adverse Event (SAE) Up to approximately 3 years An SAE is defined as any AE, whether or not related to the study drug, which results in the following outcomes:
* Death
* Life-threatening experience
* Required or prolonged inpatient hospitalization
* Persistent or significant disability/incapacity
* Congenital anomaly
* Important medical events that, based upon appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.Number of Participants who Discontinue Study Intervention due to an AE Up to approximately 3 years An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study.
Myelofibrosis (MF) Participants Only: Change from Baseline in Spleen Volume Baseline and up to approximately 3 years Spleen volume will be assessed by magnetic resonance imaging (MRI) (or computed tomography \[CT\] where applicable) at pre-specified timepoints. Change from baseline in spleen volume will be reported.
Essential Thrombocythemia (ET) Participants Only: Change from Baseline in Platelet Counts Baseline and up to approximately 3 years Blood samples will be collected at pre-specified timepoints to determine platelet counts. Change from baseline in platelet counts will be reported.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Gold Coast Hospital and Health Service
🇦🇺Southport, Queensland, Australia
Guy's and Saint Thomas' NHS Foundation Trus
🇬🇧London, United Kingdom
University of Miami Leonard M. Miller
🇺🇸Miami, Florida, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
UMPC Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
University College London Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Royal North Shore Hospital
🇦🇺Saint Leonards, New South Wales, Australia
Azienda Ospedaliero Universitaria di Bologna
🇮🇹Pavia, Italy
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Universittsklinikum Essen
🇩🇪Essen, Germany
Azienda Ospedaliero-Universitaria Careggi - S.O.D. Ematologia (CRIMM)
🇮🇹Firenze, Italy
Ospedale di Circolo-a Fondazione Macchi
🇮🇹Varese, VA, Italy
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Azienda Ospedaliera SS. Antonio
🇮🇹Alessandria, Italy
Middlemore Clinical Trials
🇳🇿Papatoetoe, Aukland, New Zealand
Waitemata District Health Board
🇳🇿Takapuna, Aukland, New Zealand