Back to resultsIMG-7289 in Patients With Myelofibrosis
Primary Purpose
Myelofibrosis, Post-polycythemia Vera Myelofibrosis (PPV-MF), Post-essential Thrombocythemia Myelofibrosis (PET-MF)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IMG-7289
Sponsored by
About this trial
This is an interventional treatment trial for Myelofibrosis focused on measuring LSD1
Eligibility Criteria
Inclusion Criteria:
- >18 years
- Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, PPV-MF or PET-MF per the IWG-MRT
- High or intermediate-2 risk disease, as defined per protocol
Exclusion Criteria:
- Receiving other treatments for the condition (with exceptions and time limits)
- Major surgery in last 4 weeks, minor 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 HIV infection or active Hepatitis B or Hepatitis C virus infection
- Other hematologic/biochemistry requirements, as per protocol
- Use of investigational agent within last 14 days
- Pregnant or lactating females
Sites / Locations
- University of Michigan
- Royal Adelaide Hospital
- Universitatsklinikum Essen
- Azienda Ospedaliero Universitaria Careggi
- Guy's and St Thomas' Hospitals
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMG-7289
Arm Description
Single starting dose with individualized dose titrations throughout
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events, and changes in physical examination, vital signs and laboratory parameters [safety and tolerability]
as measured by the frequent monitoring of: adverse events, physical examination and vital signs and laboratory parameters.
Secondary Outcome Measures
Drug Concentration (performed in Phase 1/2a only)
as measured by Cmin sampling.
Spleen Volume
Reduction in spleen volume based on MRI (or CT)
Full Information
NCT ID
NCT03136185
First Posted
April 18, 2017
Last Updated
February 8, 2023
Sponsor
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
1. Study Identification
Unique Protocol Identification Number
NCT03136185
Brief Title
IMG-7289 in Patients With Myelofibrosis
Official Title
A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 8, 2022 (Actual)
Study Completion Date
March 8, 2022 (Actual)
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 Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with myelofibrosis.
This study investigates the following:
The safety and tolerability of IMG-7289
The pharmacokinetics of IMG-7289 (performed in Phase 1/2a only)
The pharmacodynamic effect of IMG-7289
Detailed Description
With enrollment complete in Phase 1/2a, expansion into Phase 2b has occurred. New patients will be enrolled into Phase 2b study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis, Post-polycythemia Vera Myelofibrosis (PPV-MF), Post-essential Thrombocythemia Myelofibrosis (PET-MF), Primary Myelofibrosis (PMF)
Keywords
LSD1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMG-7289
Arm Type
Experimental
Arm Description
Single starting dose with individualized dose titrations throughout
Intervention Type
Drug
Intervention Name(s)
IMG-7289
Other Intervention Name(s)
LSD1 inhibitor
Intervention Description
Differentiation therapy
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events, and changes in physical examination, vital signs and laboratory parameters [safety and tolerability]
Description
as measured by the frequent monitoring of: adverse events, physical examination and vital signs and laboratory parameters.
Time Frame
Assessed from the time of first dose through 28 days after end of treatment.
Secondary Outcome Measure Information:
Title
Drug Concentration (performed in Phase 1/2a only)
Description
as measured by Cmin sampling.
Time Frame
Up to 3 months.
Title
Spleen Volume
Description
Reduction in spleen volume based on MRI (or CT)
Time Frame
Baseline to each visit where the variable is measured.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>18 years
Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, PPV-MF or PET-MF per the IWG-MRT
High or intermediate-2 risk disease, as defined per protocol
Exclusion Criteria:
Receiving other treatments for the condition (with exceptions and time limits)
Major surgery in last 4 weeks, minor 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 HIV infection or active Hepatitis B or Hepatitis C virus infection
Other hematologic/biochemistry requirements, as per protocol
Use of investigational agent within last 14 days
Pregnant or lactating females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Pettit
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Florence
Country
Italy
Facility Name
Guy's and St Thomas' Hospitals
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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IMG-7289 in Patients With Myelofibrosis
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