This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with essential thrombocythemia. This study investigates the following: - The safety and tolerability of IMG-7289 - The pharmacodynamic effect of IMG-7289
Recruiting
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| IMG-7289 | bomedemstat | IMG-7289 |
This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy and
pharmacodynamics of IMG-7289 administered orally once daily in patients with essential
thrombocythemia (ET). Patients will be dosed with IMG-7289 for 169 consecutive days in the
Initial Treatment Period (ITP). Qualifying patients may continue to receive IMG-7289 in the
Additional Treatment Period (ATP).
Safety will be evaluated by clinical assessments of safety parameters i.e. safety laboratory
testing, adverse event reporting, physical examination and vital sign assessments.
Pharmacodynamics will be evaluated by hematology assessment, patient reported symptom burden,
change in spleen size by palpation and other measures.
To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters
and pharmacodynamic markers.
| Name | Type | Description | Interventions |
|---|---|---|---|
| IMG-7289 | Experimental | IMG-7289 administered daily for 169 consecutive days |
|
Inclusion Criteria:
- Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic
criteria for myeloproliferative neoplasms.
- Requires treatment in order to lower platelet count based on patient age over 60 or
history of thrombosis.
- Have failed at least one standard therapy
- Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to
study drug initiation.
Exclusion Criteria:
- Has undergone major surgery ≤4 weeks prior to starting study drug or has not recovered
from side effects of such surgery.
- Unresolved treatment related toxicities from prior therapies (unless resolved to ≤
Grade 1).
- Uncontrolled active infection.
- Current use of prohibited medications
- 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | The safety of IMG-7289 when administered to patients with essential thrombocythemia |
| Time Frame: | Assessed from the time of first dose through 14 days after end of treatment. |
| Safety Issue: | |
| Description: | Safety measured by incidence and severity of treatment-emergent adverse events (using CTCAE), and changes in physical examination including vital signs, and hematology, coagulation, chemistry and urinalysis laboratory parameters. |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Imago BioSciences,Inc. |
July 19, 2021
