IMG-7289 in Patients With Myelofibrosis



Status:Recruiting
Conditions:Hematology, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:July 1, 2017
End Date:February 1, 2020
Contact:Jennifer Peppe
Email:jennifer.peppe@imagobio.com
Phone:+1-415-529-5055

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A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in
patients with myelofibrosis.

This study investigates the following:

- The safety and tolerability of IMG-7289

- The pharmacokinetics of IMG-7289 (performed in Phase 1/2a only)

- The pharmacodynamic effect of IMG-7289

With enrollment complete in Phase 1/2a, expansion into Phase 2b has occurred. New patients
will be enrolled into Phase 2b study.

Inclusion Criteria:

- >18 years

- Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for
myeloproliferative neoplasms, PPV-MF or PET-MF per the IWG-MRT

- High or intermediate-2 risk disease, as defined per protocol

Exclusion Criteria:

- Receiving other treatments for the condition (with exceptions and time limits)

- Major surgery in last 4 weeks, minor surgery in the last 2 weeks

- History of, or scheduled, hematopoietic stem cell transplant within 24 weeks of
Screening

- History of splenectomy

- Current use of prohibited medications

- A concurrent second active and nonstable malignancy

- Known HIV infection or active Hepatitis B or Hepatitis C virus infection

- Other hematologic/biochemistry requirements, as per protocol

- Use of investigational agent within last 14 days

- Pregnant or lactating females
We found this trial at
2
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-647-8901
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Adelaide, South Australia
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