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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
NCT02842827
Ethics application status
Date submitted
12/07/2016
Date registered
25/07/2016
Date last updated
26/02/2019

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
IMG-7289-CTP-101
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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.]

Eligibility
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
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

- 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
Treatment
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
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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

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 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
following:

- 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
https://clinicaltrials.gov/show/NCT02842827
Trial related presentations / publications
Public notes

Contacts
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