IMG-7289 in Patients with Essential Thrombocythemia (ET) or Polycythemia Vera (PV)
NCT ID: NCT04262141
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
4 participants
INTERVENTIONAL
2020-10-02
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IMG-7289 in ET and PV Patients
Oral daily dose of 0.6 mg/kg/day IMG-7289 will be administered:
* The initial pilot period will enroll 8 participants to receive oral daily dose of IMG-7829 for 24 weeks, iteratively as long as there is clinical benefit in the absence of excess toxicity.
* The second stage group will enroll an additional 16 participants to receive IMG-7829 for over 2 years, iteratively as long as there is clinical benefit in the absence of toxicity.
IMG-7289
Daily oral dose of 0.6 mg/kg/day IMG-7829 capsules. Dose escalation an de-escalation rules applied as necessary.
Interventions
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IMG-7289
Daily oral dose of 0.6 mg/kg/day IMG-7829 capsules. Dose escalation an de-escalation rules applied as necessary.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Essential Thrombocythemia or Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Arber et al., 2016).
3. Patients that have failed at least one standard therapy (failure is the equivalent of inadequate response or intolerance).
4. Platelet count \>400 x 10\^9/L pre-dose Day 1for patients with essential thrombocytopenia.
5. Platelet count \>150 x 10\^9/L pre-dose Day 1 for patients with polycythemia vera.
6. Peripheral blast count \< 10% pre-dose Day 1.
7. Absolute neutrophil count (ANC) ≥ 0.5 x 10\^9/L pre-dose Day 1.
8. Fibrosis score ≤ grade 2, as per a slightly modified version (Arber et al., 2016) of the European Consensus Criteria for Grading Myelofibrosis, (Thiele et al., 2005).
9. Life expectancy \> 36 weeks.
10. Able to swallow capsules.
11. Amenable to blood draws, spleen size determination, bone marrow evaluations, and peripheral blood sampling during the study.
12. Must have discontinued prior therapy for condition under study for 2 weeks (4 weeks for interferon) prior to study drug initiation.
13. Agrees to use an approved method of contraception from Screening until 28 days after last administration of the study drug.
14. If male, agrees not to donate sperm or father a child for at least one month after the last dose of the study medication.
Exclusion Criteria
2. Currently pregnant, planning on being pregnant in the following 6 months or currently breastfeeding.
3. Currently residing outside the United States.
4. History of splenectomy.
5. Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1).
6. Uncontrolled active infection.
7. Known positive for HIV if not well-controlled (i.e., undetectable viral load), or infectious hepatitis, type A, B or C.
8. Current use of monoamine oxidase A and B inhibitors (MAOIs).
9. Evidence at the time of screening of increased risk of bleeding, including any of the following:
* Activated partial thromboplastin time (aPTT) \> 1.3 x the upper limit of normal
* International normalized ratio (INR) \>1.3 x the local upper limit of normal
* History of severe thrombocytopenia or platelet dysfunction unrelated to a myeloproliferative disorder or its treatment
* Known bleeding disorder (e.g., dysfibrinogenaemia, factor IX deficiency, haemophilia, Von Willebrand's disorder, Disseminated Intravascular Coagulation \[DIC\], fibrinogen deficiency, or other clotting factor deficiency)
10. Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to haemolysis, or leukaemic infiltration) as defined by any of the following local lab parameters:
1. Calculated glomerular filtration rate (GFR; using the Cockcroft-Gault equation) \< 40 mL/min or serum creatinine \> 1.5 x the local upper limit of normal
2. Aspartate transaminase (AST) or alanine aminotransferase (ALT) ≥ 2 x the local upper limit of normal
11. Current use of a prohibited medication (e.g., romiplostim) or expected to require any of these medications during treatment with the investigational drug.
12. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to IMG-7289 or LSD1 inhibitors (i.e., monoamine oxidase inhibitors; MAOIs) that contraindicates their participation.
13. Patients with impaired decision-making capacity.
18 Years
ALL
No
Sponsors
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Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
INDUSTRY
Terrence J Bradley, MD
OTHER
Responsible Party
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Terrence J Bradley, MD
Assistant Professor
Principal Investigators
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Terrence J Bradley, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Other Identifiers
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20190932
Identifier Type: -
Identifier Source: org_study_id