Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06502145
Phase
PHASE1
Status
Recruiting
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Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine Level -1 — DRUG
    Intravenous (IV) or subcutaneous (SC) 75 mg / m\^2 days 1-7 X 28 days.
  • Azacitidine Level 0 — DRUG
    Intravenous (IV) or subcutaneous (SC) 75 mg / m\^2 days 1-7 X 28 days.
  • Azacitidine Level 1 — DRUG
    Intravenous (IV) or subcutaneous (SC) 75 mg / m\^2 days 1-7 X 28 days.
  • Iadademstat Level -1 — DRUG
    75 µg by mouth (PO) 5 days on, 2 days off for 2 weeks every 28 days.
  • Iadademstat Level 0 — DRUG
    75 µg PO 5 days on, 2 days off for 3 weeks every 28 days.
  • Iadademstat Level 1 — DRUG
    100 µg PO 5 days on, 2 days off for 3 weeks every 28 days.

Study Details

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).

Key Dates

Start date
Jan 10, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose level -1
    Dose level -1 will be considered only if there are dose-limiting toxicities at dose level 0. This is a regimen of azacitidine and iadademstat.
  • Experimental: Dose level 0
    This is a regimen of azacitidine and iadademstat.
  • Experimental: Dose level 1
    This is a regimen of azacitidine and iadademstat.
  • Experimental: Maximum Tolerated Dose (MTD)
    The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a dose-limiting toxicity.

Primary Outcome Measure

Recommended phase II dose of Iadademstat. [ Time Frame: Up to two years ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
Guru Subramanian Guru Murthy, MD, MS
[email protected]
Guru Subramanian Guru Murthy, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Froedtert Hospital & the Medical College of Wisconsin· Milwaukee, WI

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