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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03136185




Registration number
NCT03136185
Ethics application status
Date submitted
18/04/2017
Date registered
2/05/2017
Date last updated
27/02/2019

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
IMG-7289-CTP-102
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
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
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
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

Outcomes
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.

Eligibility
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
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

Study design
Purpose of the study
Treatment
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
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
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
Michigan

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

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/show/NCT03136185
Trial related presentations / publications
Public notes

Contacts
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
+1-415-529-5055
Fax 0 0
Email 0 0
jennifer.peppe@imagobio.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03136185