EUCTR2018-003811-23-DE
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Imago BioSciences, Inc.
- Enrollment
- 90
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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) intermediate risk\-2 (2 prognostic factors) or intermediate risk\-1 (1 prognostic factor). 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)\*;
Exclusion Criteria
- •1\. Has undergone major surgery \=4 weeks prior to starting study drug or has not recovered from side effects of such
- •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.
Outcomes
Primary Outcomes
Not specified
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