IMG-7289 in Patients With Essential Thrombocythemia
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|ClinicalTrials.gov Identifier: NCT04254978|
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : June 22, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Essential Thrombocythemia||Drug: IMG-7289||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multi-center, open-label|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy and Pharmacodynamics of IMG-7289 in Patients With Essential Thrombocythemia|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||June 2022|
IMG-7289 administered daily for 169 consecutive days
Other Name: bomedemstat
- 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 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.
- The efficacy of IMG-7289 when administered to patients with essential thrombocythemia [ Time Frame: Assessed serially at each visit from time of first dose through 14 days after end of treatment ]Change in platelet counts to the protocol defined target threshold, in the absence of new thromboembolic events
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): NCT04254978
|Contact: Jennifer Peppeemail@example.com|
|Contact: Amber Jonesfirstname.lastname@example.org|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Trinity Samson TaussigResearch@ccf.org|
|Study Director:||Hugh Rienhoff, MD||Imago BioSciences|