Clinical trial NCT05223920: Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thrombocythemia, Essential
Primary Myelofibrosis
Lead sponsor: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2022-02-04
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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').


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants who Experience an Adverse Event (AE)
timeFrame: Up to approximately 3 years
measure: Number of Participants who Experience a Serious Adverse Event (SAE)
timeFrame: Up to approximately 3 years
measure: Number of Participants who Discontinue Study Intervention due to an AE
timeFrame: Up to approximately 3 years
measure: Myelofibrosis (MF) Participants Only: Change from Baseline in Spleen Volume
timeFrame: Baseline and up to approximately 3 years
measure: Essential Thrombocythemia (ET) Participants Only: Change from Baseline in Platelet Counts
timeFrame: Baseline and up to approximately 3 years
Secondary outcomes:
Other outcomes:
measure: Participant-reported Symptom Burden Response Rate on the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Total Symptom Score (TSS)
timeFrame: Baseline and up to approximately 3 years
measure: MF Participants: Objective Response Rate (ORR)
timeFrame: Up to approximately 3 years
measure: MF Participants: Duration of Response (DOR)
timeFrame: Up to approximately 3 years
measure: ET Participants: ORR
timeFrame: Up to approximately 3 years
measure: ET Participants: DOR
timeFrame: Up to approximately 3 years
measure: Change from Baseline in Spleen Size
timeFrame: Baseline and up to approximately 3 years
measure: Change from Baseline in the Mutant (Variant) Allele Burden
timeFrame: Baseline and up to approximately 3 years
measure: Change from Baseline in Complete Blood Count (CBC)
timeFrame: Baseline and up to approximately 3 years
measure: ET Participants Only: Change from Baseline in the Patient Global Impression of Change (PGIC) Score
timeFrame: Baseline and up to approximately 3 years
measure: ET Participants Only: Number of Participants who Experience a Thrombotic or Hemorrhagic Event
timeFrame: Baseline and up to approximately 3 years
Locations:
city: Miami
country: United States
facility: University of Miami Leonard M. Miller
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Pittsburgh
country: United States
facility: UMPC Hillman Cancer Center
state: Pennsylvania
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast Hospital and Health Service
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Essen
country: Germany
facility: Universittsklinikum Essen
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Varese
country: Italy
facility: Ospedale di Circolo-a Fondazione Macchi
state: VA
city: Alessandria
country: Italy
facility: Azienda Ospedaliera SS. Antonio
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi - S.O.D. Ematologia (CRIMM)
city: Pavia
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna
city: Papatoetoe
country: New Zealand
facility: Middlemore Clinical Trials
state: Aukland
city: Takapuna
country: New Zealand
facility: Waitemata District Health Board
state: Aukland
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and Saint Thomas' NHS Foundation Trus
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: