Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome
Medical College of Wisconsin
Summary
This is a phase I study with a primary objective of determining the recommended phase II dose of iadademstat with azacitidine in adult subjects with myelodysplastic syndrome (MDS).
Description
This is a single-arm, open-label phase 1 study designed to evaluate the safety of iadademstat with azacitidine therapy. The trial will follow a 3+3 phase 1 dose-escalation design. First, three participants are given a low dose of the experimental treatment and monitored for pre-specified toxicity events. If 0 participants experience one of these toxicity events, then the next group of three participants is enrolled at a higher dose. If two or three participants experience toxicity, then the next group of three participants is enrolled at a lower dose (or the study ends). If one participant ex…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female 18 years or older. 2. Patients must have a diagnosis of myelodysplastic syndrome (MDS), or MDS / myeloproliferative neoplasm (MPN), chronic myelomonocytic leukemia (CMML) as defined by the World Health Organization (WHO) criteria. 3. Intermediate, high, or very-high risk by the Revised International Prognostic Scoring System (IPSS-R). 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (0-3 if performance status is considered due to MDS). 5. Patient must have a body weight of at least 50 kg. 6. Patient must meet the following screening…
Interventions
- DrugAzacitidine Level -1
Intravenous (IV) or subcutaneous (SC) 75 mg / m\^2 days 1-7 X 28 days.
- DrugAzacitidine Level 0
Intravenous (IV) or subcutaneous (SC) 75 mg / m\^2 days 1-7 X 28 days.
- DrugAzacitidine Level 1
Intravenous (IV) or subcutaneous (SC) 75 mg / m\^2 days 1-7 X 28 days.
- DrugIadademstat Level -1
75 µg by mouth (PO) 5 days on, 2 days off for 2 weeks every 28 days.
- DrugIadademstat Level 0
75 µg PO 5 days on, 2 days off for 3 weeks every 28 days.
- DrugIadademstat Level 1
100 µg PO 5 days on, 2 days off for 3 weeks every 28 days.
Location
- Froedtert Hospital & the Medical College of WisconsinMilwaukee, Wisconsin