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 |
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
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.
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
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