Bomedemstat in Patients With Polycythemia Vera
Study Details
Study Description
Brief Summary
This is a Phase 2 open label study of an orally administered LSD1 inhibitor, bomedemstat (IMG-7289), in patients with polycythemia vera.
This study investigates the following:
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The safety and tolerability of bomedemstat
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The pharmacodynamic effect of bomedemstat
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of bomedemstat administered orally once daily in patients with polycythemia vera.
Patients will receive 36 weeks of dosing and may qualify for additional treatment thereafter.
Patients will be followed closely throughout the study for both Adverse Events by frequent monitoring of clinical signs and symptoms as well as safety labs. Efficacy and pharmacodynamic effects will be closely monitored by frequent hematology assessments of peripheral blood. Throughout dosing, transfusions or phlebotomy may be administered if needed in accordance with standard institutional guidelines.
To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: bomedemstat bomedemstat administered daily for 36 weeks |
Drug: bomedemstat
LSD1 inhibitor
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment-emergent adverse events [Assessed from baseline through 14 days after end of treatment]
Incidence and severity of treatment-emergent adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
- Incidence of patients who achieve a reduction of hematocrit [Assessed serially at each visit from baseline through week 36]
Incidence of patients who achieve a reduction of hematocrit (Hct) to <45% without phlebotomy.
Secondary Outcome Measures
- Evaluate the duration of change in hematocrit [Assessed from baseline through week 36]
Incidence of patients with a durable change of hematocrit to <45% without phlebotomy
- Pharmacodynamics of bomedemstat on platelet count [Assessed from baseline through week 36]
Incidence and durability of reduction of platelet count
- Pharmacodynamics of bomedemstat on WBC [Assessed from baseline through week 36]
Incidence and durability of reduction of white blood cell (WBC) count
- Incidence of thrombotic and hemorrhagic events [Assessed from baseline through week 36]
Incidence of new thrombotic or hemorrhagic events
- Incidence of spleen volume reduction [Assessed from baseline through week 36]
Incidence of achieving a reduction in spleen volume in patients with enlarged spleen at baseline
- Incidence of disease progression [Assessed from baseline through week 36]
Incidence of progression to post-polycythemia vera myelofibrosis, myelodysplastic syndrome or transformation to acute myeloid leukemia
- Evaluate pharmacokinetics: maximum plasma concentration (Cmax) of bomedemstat [Assessed Day 1 up to Day 57]
Calculate Cmax with sparse blood sampling
- Evaluate pharmacokinetics: exposure of bomedemstat [Assessed Day 1 up to Day 57]
Calculate area under the curve (AUC) with sparse blood sampling
- Evaluate pharmacokinetics: half life of bomedemstat [Assessed Day 1 up to Day 57]
Calculate half life (t 1/2) with sparse blood sampling
- Evaluate the change in patient reported symptoms on the MFSAF [Assessed from baseline through week 36]
Change in patient-reported symptom burden as evaluated by the Myelofibrosis Symptom Assessment Form (MFSAF); scoring of 0-70 with higher scores representing a worse outcome
- Evaluate the change in patient reported symptoms on the PGIC [Assessed from week 12 through week 36]
Change in patient-reported symptom burden as evaluated by Patients' Global Impression of Change (PGIC) scale
- Evaluate duration of change in patient-reported symptom burden [Assessed from baseline through week 36]
Incidence of patients achieving a durable reduction of the MFSAF Score
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms
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Bone marrow fibrosis score of Grade 0 or Grade 1
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Patients that have failed at least one standard cytoreductive therapy to lower hematocrit
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Platelet count ≥250 x 10ˆ9/L
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Absolute neutrophil count (ANC) ≥1.5 x 10ˆ9/L
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Life expectancy >36 weeks.
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Must have discontinued prior cytoreductive therapy for 2 weeks (4 weeks for interferon) prior to study drug initiation.
Exclusion Criteria:
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Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater
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Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1).
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Uncontrolled active infection.
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Current use of prohibited medications
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Known HIV infection or active Hepatitis B or Hepatitis C virus infection
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Evidence of increased risk of bleeding, including known bleeding disorders
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Other hematologic/biochemistry requirements, as per protocol
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Pregnant or lactating females
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Imago BioSciences,Inc.
Investigators
- Study Director: Hugh Rienhoff, MD, Imago BioSciences,Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IMG-7289-CTP-203