A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients with Myelofibrosis. - IMG-7289-CTP-102 Phase 2b expansion

Imago BioSciences Inc.0 sites75 target enrollmentNovember 7, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with myelofibrosis including primary myelofibrosis (PMF), post-polycythaemia vera myelofibrosis (PPV-MF), and post-essential thrombocythaemia myelofibrosis (PET-MF) (collectively referred to as ‘MF’)
Sponsor: Imago BioSciences Inc.
Enrollment: 75
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

November 7, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Willing and able to sign the approved informed consent.
•2\.Age: 18\+ years old at Screening.
•3\.Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Section 16\.2\), PPV\-MF per the IWG\-MRT (Section 16\.3\), or PET\-MF per the IWG\-MRT (Section 16\.4\) and meet the following additional subtype specific criteria:
•a.Classified as high risk (3 prognostic factors) OR intermediate risk\-2 (2 prognostic factors). The prognostic factors, defined by the International Working Group (Cervantes, et al., 2009\):
•i.Age \> 65 years;
•ii.Presence of constitutional symptoms (weight loss, fever, night sweats);
•iii.Marked anaemia (Hgb \< 10g/dL)\*;
•iv.History of leukocytosis \[WBC \> 25 x109/L (25,000/µL)];
•v.Circulating blasts \= 1%.
•\*A haemoglobin value \< 10 g/dL must be demonstrated during Screening for patients who are not transfusion dependent. Patients receiving regular transfusions of packed red blood cells will be considered to have haemoglobin \< 10 g/dL for the purpose of evaluation of risk factors.

•1\.Has undergone major surgery \=4 weeks prior to starting study drug or has not recovered from side effects of such surgery.
•2\.Has undergone any surgical procedure within 2 weeks, excluding minor procedures (e.g., skin biopsy or central venous catheter placement/removal) prior to starting study drug.
•3\.History of splenectomy.
•4\.History of or scheduled haematopoietic stem\-cell transplant within 24 weeks of screening.
•5\.Unresolved treatment related toxicities from prior therapies (unless resolved to \= Grade 1\).
•6\.Current use of a prohibited medication (e.g., romiplostim) or expected to require any of these medications during treatment with the investigational drug.
•7\.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.
•8\.Current use of monoamine oxidase A and B inhibitors (MAOIs).
•9\.Uncontrolled active infection.
•10\.A concurrent second active and non\-stable malignancy (patients with a concurrent second active but stable malignancy, such as non\-melanoma skin cancers, are eligible).