IMG-7289-CTP-102 Phase 2b expansion
Research type
Research Study
Full title
A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients with Myelofibrosis.
IRAS ID
257138
Contact name
Claire Harrison
Contact email
Sponsor organisation
Imago BioSciences Inc.
Eudract number
2018-003811-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
This is a clinical study of the safety and efficacy of IMG-7289, an inhibitor of an enzyme (LSD1) involved in blood cell development, for the treatment of myelofibrosis in 50 patients over the age of 18. All patients enrolled will be refractory or resistant to, inadequately controlled by or intolerant of available approved therapy, or in the Investigator’s judgment, not candidates for available approved therapy. Patients will need to discontinue any current therapy at least 2 weeks prior to the first dose of IMG-7289. During the Initial Treatment Period, patients will be treated once daily with IMG-7289 for 169 days. All patients will start at a dose of 0.5 mg/kg/day taken by mouth. The dose may be adjusted on an individual patient basis depending on how the platelet count responds to treatment – the therapeutic dose is that which brings the platelet count into the range of ≥ 50,000 to ≤ 75,000/µL (50-75 x 109/L). Patients will be assessed in clinic at specified times and this includes adverse event monitoring, vital signs, blood sampling for safety and research purposes (including DNA and immune hormones), urinalysis, and physical examinations including spleen measurement. Patients will also undergo: a bone marrow aspirate and biopsy twice during the study, once at study entry and again at Week 24; and, an MRI scan (or CT) 3 times during the study, at Day 0, Weeks 12 and 24. Patients may continue to receive IMG-7289 if, in the opinion of their study doctor, they have safely derived clinical benefit from IMG-7289.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0051
Date of REC Opinion
28 Mar 2019
REC opinion
Further Information Favourable Opinion