ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02842827
Recruitment Status : Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Imago BioSciences,Inc.

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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Drug: IMG-7289 Drug: All-trans retinoic acid Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Multiple ascending dose
MAD Cohorts using IMG-7289 alone
Drug: IMG-7289
LSD1 inhibitor

Experimental: Combination Therapy
IMG-7289 in combination with all-trans retinoic acid (ATRA)
Drug: IMG-7289
LSD1 inhibitor

Drug: All-trans retinoic acid
Derivative of Vitamin A, differentiating agent.
Other Name: ATRA, tretinoin, Vesanoid®

Experimental: Ascending duration
Treatment duration extension Cohorts using IMG-7289 alone
Drug: IMG-7289
LSD1 inhibitor




Primary Outcome Measures :
  1. Safety and tolerability as measured by monitoring of adverse events, changes in physical examinations, vital signs and laboratory parameters [ Time Frame: Assessed from time of first dose through 28 days after end of treatment. ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters as measured by acute and steady state sampling [ Time Frame: 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) ]
  2. The adequacy of the treatment regimen in producing a pharmacodynamic effect as measured by the IWG/Cheson response criteria [ Time Frame: Assessed from time of first dose through approximately 28 initial days of treatment.] ]
    Peripheral blood and bone marrow will be collected serially for assessment of response.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842827


Locations
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Sponsors and Collaborators
Imago BioSciences,Inc.
Investigators
Principal Investigator: Ian Lewis Royal Adelaide Hospital

Responsible Party: Imago BioSciences,Inc.
ClinicalTrials.gov Identifier: NCT02842827     History of Changes
Other Study ID Numbers: IMG-7289-CTP-101
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Imago BioSciences,Inc.:
LSD1

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents