Fimepinostat, Combination HDAC and Pi3-kinase Inhibitor Tumor-Directed Therapy for Cushing Disease

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05971758
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cushing Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Fimepinostat — DRUG
    The study will allow us to determine the efficacy and safety of these doses in the treatment of Cushing Disease (CD) and guide dose selection for subsequent, larger studies.

Study Details

Supported by the pre-clinical data (summarized in Research Strategy), the investigators propose that Fimepinostat is an ideal candidate drug in the treatment and intervention of patients with Cushing Disease. The investigators propose a pilot, short-term (4 weeks) phase II single-center study to demonstrate the safety and efficacy of Fimepinostat in the treatment of patients with de novo, persistent, and/or recurrent CD recruited at the University of California, Los Angeles. The trial will have a 2-arm design and will simultaneously examine two different doses of Fimepinostat. The study will allow the investigators to determine the efficacy and safety of these doses in the treatment of CD and guide dose selection for subsequent, larger studies. Funding Source - FDA OOPD.

Key Dates

Start date
Jan 16, 2025
Status verified
Jul 2025
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fimepinostat 60mg
    two 30mg capsules once a day, 10 subjects
  • Active Comparator: Fimepinostat 30mg
    single 30mg capsule daily in 10 subjects

Primary Outcome Measure

Number of participants with mUFC ≤ 1.0xULN [ Time Frame: Baseline, 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ronald Reagan Medical CenterLos AngelesCalifornia90095-

Find similar trials in Los Angeles, CA

By research site
Ronald Reagan Medical Center· Los Angeles, CA

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