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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02842827

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

Titles & IDs
Public title
IMG-7289, With and Without ATRA, in Patients With Advanced Myeloid Malignancies
Scientific title
A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 With and Without ATRA (Tretinoin) in Patients With Advanced Myeloid Malignancies
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Myelodysplastic Syndrome 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

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

Experimental: Multiple ascending dose - MAD Cohorts using IMG-7289 alone

Experimental: Combination Therapy - IMG-7289 in combination with all-trans retinoic acid (ATRA)

Experimental: Ascending duration - Treatment duration extension Cohorts using IMG-7289 alone

Treatment: Drugs: IMG-7289
LSD1 inhibitor

Treatment: Drugs: All-trans retinoic acid
Derivative of Vitamin A, differentiating agent.

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

Primary outcome [1] 0 0
Safety and tolerability as measured by monitoring of adverse events, changes in physical examinations, vital signs and laboratory parameters
Timepoint [1] 0 0
Assessed from time of first dose through 28 days after end of treatment.
Secondary outcome [1] 0 0
Pharmacokinetic parameters as measured by acute and steady state sampling
Timepoint [1] 0 0
Cohort 1, Cycle 1 (14 days): Day 1 (pre-dose and 1, 2, 3 and 24 hrs post dose), Day 7 (pre-dose and 0.5, 1, 2, 3, 4, 8, 24, 48, 96 and 168 hrs post dose)
Secondary outcome [2] 0 0
The adequacy of the treatment regimen in producing a pharmacodynamic effect as measured by the IWG/Cheson response criteria - Peripheral blood and bone marrow will be collected serially for assessment of response.
Timepoint [2] 0 0
Assessed from time of first dose through approximately 28 initial days of treatment.]

Key inclusion criteria
- >18 years

- Diagnosis of either AML (all subtypes excluding APL-AML) or MDS by World Health
Criteria (WHO)

- High 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

- Scheduled hematopoietic stem-cell transplant

- Current use of prohibited medications

- Clinical evidence of central nervous system (CNS) or pulmonary leukostasis,
disseminated intravascular coagulation, or CNS leukemia

- A concurrent second active and non-stable 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
Non-randomised trial
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 1
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

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

Ethics approval
Ethics application status

Brief summary
This is a Phase 1 open label study of the dose and duration of an orally administered LSD1
inhibitor, IMG-7289, in patients with acute myeloid leukemia (AML) and myelodysplastic
syndrome (MDS). Some participants may also receive all-trans retinoic acid (ATRA; also known
as tretinoin and Vesanoid®) in combination with IMG-7289. This study investigates the

- The safety and tolerability of IMG-7289, with and without ATRA

- The pharmacodynamic effect of different IMG-7289 doses and treatment durations, as well
as IMG-7289 administered in combination with ATRA

- The pharmacokinetics of IMG-2789, with and without ATRA
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
David Ross
Address 0 0
Royal Adelaide Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications