CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
bomedemstat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02842827
NCT02842827Phase 2Completed

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

Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)·interventional·Posted Jul 25, 2016·Updated Jul 11, 2023

In Brief

A Phase 2 clinical trial evaluating bomedemstat and tretinoin for Acute Myeloid Leukemia and Myelodysplastic Syndrome. Completed, enrolled 45 participants across 1 site.

Detailed Summary

This is an open label study of the dose and duration of an orally administered lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat, in patients with high-risk acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Some participants may also receive all-trans retinoic acid (ATRA; also known as tretinoin and Vesanoid®) in combination with bomedemstat. This study investigates the following: * The safety and tolerability of bomedemstat with and without ATRA * The pharmacodynamic effect of different doses of bomedemstat and treatment durations, as well as bomedemstat administered in combination with ATRA * The pharmacokinetics of bomedemstat with and without ATRA

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 25, 2016
Enrollment StartOct 6, 2016
Primary CompletionOct 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.9 years ago

Interventions

bomedemstatdrug

oral administration

tretinoindrug

oral administration