Back to resultsExtension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)
Primary Purpose
Thrombocythemia, Essential, Primary Myelofibrosis
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bomedemstat
Sponsored by
About this trial
This is an interventional treatment trial for Thrombocythemia, Essential
Eligibility Criteria
Inclusion Criteria:
- 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).
- 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.
Sites / Locations
- University of Miami Leonard M. Miller
- University of Michigan
- Cleveland Clinic Foundation
- UMPC Hillman Cancer Center
- Fred Hutchinson Cancer Center
- Royal Prince Alfred Hospital
- Royal North Shore Hospital
- Gold Coast Hospital and Health Service
- Royal Adelaide Hospital
- Universittsklinikum Essen
- Queen Mary Hospital
- Ospedale di Circolo-a Fondazione Macchi
- Azienda Ospedaliera SS. Antonio
- Azienda Ospedaliero-Universitaria Careggi - S.O.D. Ematologia (CRIMM)
- Azienda Ospedaliero Universitaria di Bologna
- Middlemore Clinical Trials
- Waitemata District Health Board
- University College London Hospitals NHS Foundation Trust
- Guy's and Saint Thomas' NHS Foundation Trus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bomedemstat
Arm Description
Participants will receive bomedemstat daily for 169 days with additional treatment continuing in participants deriving clinical benefit.
Outcomes
Primary Outcome Measures
Number of Participants who Experience an Adverse Event (AE)
An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient 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)
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 with Clinically Significant Change from Baseline in One or More Vital Signs
Vital signs will include resting heart rate, semi-supine systolic/diastolic blood pressure, respiratory rate and body temperature. Clinical significance will be determined by the investigator.
Number of Participants with Clinically Significant Changes from Baseline in One or More Laboratory Parameters
Laboratory investigation will include hematology, coagulation, clinical chemistry and urinalysis. Clinical significance will be determined by the investigator.
Myelofibrosis (MF) Participants Only: Change from Baseline in Spleen Volume
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
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
Full Information
NCT ID
NCT05223920
First Posted
August 31, 2021
Last Updated
July 11, 2023
Sponsor
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
1. Study Identification
Unique Protocol Identification Number
NCT05223920
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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').
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocythemia, Essential, Primary Myelofibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bomedemstat
Arm Type
Experimental
Arm Description
Participants will receive bomedemstat daily for 169 days with additional treatment continuing in participants deriving clinical benefit.
Intervention Type
Drug
Intervention Name(s)
Bomedemstat
Other Intervention Name(s)
IMG-7289, MK-3543
Intervention Description
Capsule (oral)
Primary Outcome Measure Information:
Title
Number of Participants who Experience an Adverse Event (AE)
Description
An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with bomedemstat under this protocol until completion of the study.
Time Frame
Up to approximately 3 years
Title
Number of Participants who Experience a Serious Adverse Event (SAE)
Description
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.
Time Frame
Up to approximately 3 years
Title
Number of Participants with Clinically Significant Change from Baseline in One or More Vital Signs
Description
Vital signs will include resting heart rate, semi-supine systolic/diastolic blood pressure, respiratory rate and body temperature. Clinical significance will be determined by the investigator.
Time Frame
Baseline and up to approximately 3 years
Title
Number of Participants with Clinically Significant Changes from Baseline in One or More Laboratory Parameters
Description
Laboratory investigation will include hematology, coagulation, clinical chemistry and urinalysis. Clinical significance will be determined by the investigator.
Time Frame
Baseline and up to approximately 3 years
Title
Myelofibrosis (MF) Participants Only: Change from Baseline in Spleen Volume
Description
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.
Time Frame
Baseline and up to approximately 3 years
Title
Essential Thrombocythemia (ET) Participants Only: Change from Baseline in Platelet Counts
Description
Blood samples will be collected at pre-specified timepoints to determine platelet counts. Change from baseline in platelet counts will be reported.
Time Frame
Baseline and up to approximately 3 years
Other Pre-specified Outcome Measures:
Title
Participant-reported Symptom Burden Response Rate on the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Total Symptom Score (TSS)
Description
The MPN-SAF is a questionnaire to assess symptoms including fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers. Participant responses for each symptom is scored on an 11-point scale (0 = absent/as good as it can be to 10 = worst imaginable/as bad as it can be). The MPN-SAF TSS is the summation of all the individual scores on a 100-point scale. The participant-reported symptom burden response rate will be assessed as the change from baseline in the percentage of participants who achieve a ≥50% reduction to the MPN-SAF TSS.
Time Frame
Baseline and up to approximately 3 years
Title
MF Participants: Objective Response Rate (ORR)
Description
ORR is the percentage of participants with Complete Response (CR) or Partial Response (PR) per International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European Leukemia Network (ELN) response criteria. For MF participants, CR is, in bone marrow: age-adjusted normocellularity, <5% blasts; ≤grade 1 MF AND hemoglobin (Hb) ≥100 g/L and <upper normal limit (UNL); neutrophil count ≥ 1 x 10^9/L and <UNL; platelet count ≥100 x 10^9/L and <UNL; <2% immature myeloid cells AND resolution of disease symptoms; spleen and liver not palpable; no evidence of extramedullary hematopoiesis. For MF participants, PR is all CR criteria WITH Hb ≥85 but <100 g/L and platelet count ≥50, but <100 x 10^9/L and <UNL OR WITHOUT bone marrow criteria.
Time Frame
Up to approximately 3 years
Title
MF Participants: Duration of Response (DOR)
Description
For participants who demonstrate a confirmed CR or PR, DOR is defined as the time from CR or PR to documented progressive disease (PD) or death. For MF participants, PD is the appearance of a new splenomegaly that is palpable at least 5 cm below the left costal margin (LCM) OR a ≥100% increase in palpable distance, below LCM, for baseline splenomegaly of 5-10 cm OR a 50% increase in palpable distance, below LCM, for baseline splenomegaly of >10 cm OR leukemic transformation confirmed by a bone marrow blast count of ≥20% OR a peripheral blood blast content of ≥20% associated with an absolute blast count of ≥1 x 109/L that lasts for at least 2 weeks.
Time Frame
Up to approximately 3 years
Title
ET Participants: ORR
Description
ORR is the percentage of participants with CR or PR per IWG-MRT and ELN response criteria. For ET participants, CR is durable resolution of disease-related signs, AND platelet count ≤400 x 10^9/L, WBC count <10 x 10^9/L, absence of leukoerythroblastosis, AND without signs of progressive disease, and absence of any hemorrhagic or thrombotic events, AND bone marrow histological remission. For ET participants, PR is all CR criteria WITHOUT bone marrow histological remission.
Time Frame
Up to approximately 3 years
Title
ET Participants: DOR
Description
For participants who demonstrate a confirmed CR or PR, DOR is defined as the time from CR or PR to documented PD or death. For ET participants, PD is transformation into PV, post-ET myelofibrosis, myelodysplastic syndrome, or acute leukemia.
Time Frame
Up to approximately 3 years
Title
Change from Baseline in Spleen Size
Description
Spleen size will be measured by palpation at pre-specified timepoints. The change from baseline in spleen size will be presented.
Time Frame
Baseline and up to approximately 3 years
Title
Change from Baseline in the Mutant (Variant) Allele Burden
Description
Mutant (variant) allele burden will be assessed by genetic testing of germline samples, peripheral blood, and bone marrow at pre-specified timepoints. The change from baseline in the mutant allele burden will be presented.
Time Frame
Baseline and up to approximately 3 years
Title
Change from Baseline in Complete Blood Count (CBC)
Description
CBC will include red and white blood cell (RBC and WBC) and circulating blast cell counts. Blood samples will be taken at pre-specified timepoints to determine CBC. The change from baseline in CBC will be presented.
Time Frame
Baseline and up to approximately 3 years
Title
ET Participants Only: Change from Baseline in the Patient Global Impression of Change (PGIC) Score
Description
The PGIC is a single-score questionnaire and is scored on a scale of 1 to 7. A higher score indicates a worse outcome. The changes from baseline in the PGIC score will be reported.
Time Frame
Baseline and up to approximately 3 years
Title
ET Participants Only: Number of Participants who Experience a Thrombotic or Hemorrhagic Event
Description
The number of participants who experience a thrombotic or hemorrhagic event will be reported
Time Frame
Baseline and up to approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Miami Leonard M. Miller
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
UMPC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Royal North Shore Hospital
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Gold Coast Hospital and Health Service
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Universittsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Ospedale di Circolo-a Fondazione Macchi
City
Varese
State/Province
VA
ZIP/Postal Code
2100
Country
Italy
Facility Name
Azienda Ospedaliera SS. Antonio
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi - S.O.D. Ematologia (CRIMM)
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Bologna
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Middlemore Clinical Trials
City
Papatoetoe
State/Province
Aukland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Waitemata District Health Board
City
Takapuna
State/Province
Aukland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 12G
Country
United Kingdom
Facility Name
Guy's and Saint Thomas' NHS Foundation Trus
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)
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