IMG-7289, With and Without ATRA, in Patients With Advanced Myeloid Malignancies

• Status: Completed
• Trial end date: 2018-12-12
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imago BioSciences,Inc.
• Treatments: Tretinoin

Criteria

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

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