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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
IMG-7289 in Patients With Myelofibrosis
Scientific title
A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelofibrosis 0 0
Post-polycythemia Vera Myelofibrosis (PPV-MF) 0 0
Post-essential Thrombocythemia Myelofibrosis (PET-MF) 0 0
Primary Myelofibrosis (PMF) 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Study type
Description of intervention(s) / exposure
Treatment: Drugs - IMG-7289

Experimental: IMG-7289 - Single starting dose with individualized dose titrations throughout

Treatment: Drugs: IMG-7289
Differentiation therapy

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Assessed from the time of first dose through 28 days after end of treatment.
Secondary outcome [1] 0 0
Drug Concentration (performed in Phase 1/2a only) - as measured by Cmin sampling.
Timepoint [1] 0 0
Up to 3 months.
Secondary outcome [2] 0 0
Spleen Volume - Reduction in spleen volume based on MRI (or CT)
Timepoint [2] 0 0
Baseline to each visit where the variable is measured.

Key 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
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key 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

- 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

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Country [2] 0 0
State/province [2] 0 0
Country [3] 0 0
United Kingdom
State/province [3] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Imago BioSciences,Inc.

Ethics approval
Ethics application status

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
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Kristen Pettit
Address 0 0
University of Michigan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jennifer Peppe
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see