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Fimepinostat for Cushing Disease

This study is testing a drug called Fimepinostat for people with Cushing Disease (CD). Cushing Disease is a condition where your body makes too much of a hormone called cortisol. Researchers want to see how safe and effective Fimepinostat is at two different doses. To join, you must be at least 18 years old and have confirmed Cushing syndrome that started in the pituitary gland. This means you have consistently high levels of cortisol in your urine and normal or high levels of another hormone called ACTH. The main goal is to see if Fimepinostat can lower your urine cortisol levels to a healthy range within 4 weeks. The current status of this study is unclear, but it plans to enroll 20 participants.

Study design
This is a pilot, short-term (4 weeks) study that will test two different doses of Fimepinostat. It will enroll 20 participants at a single location.
What's involved
You would receive Fimepinostat and have your urine cortisol levels measured at the start of the study and again after 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 4 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05971758

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of California, Los Angeles
~20 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Fimepinostat

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with mUFC ≤ 1.0xULN
Measured over Baseline, 4 weeks

Conditions

Cushing Disease

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Cushing Disease

NCT05971758

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ronald Reagan Medical Center

    Los Angeles, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Anthony Heaney, MD
[email protected]
310-825-5874
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Male and female patients at least 18 years old
Patients with confirmed pituitary origin Cushing syndrome defined as 1, 2\& 3 or 4 \& 5 below:
Levo-ketoconazole): 2 weeks
SRLs (pasireotide): 2 weeks
Progesterone receptor antagonist (mifepristone): 2 weeks
Dopamine agonists (cabergoline): 4 weeks
CYP3A4 strong inducers or inhibitors: varies between drugs; minimum 5-6 times the half-life of drug

Exclusion

Patients with compromised visual fields, or evidence of visual changes within past 6 months
Patients with sellar tumor abutting or compressing the optic chiasm on MRI and normal visual fields
Patients with Cushing's syndrome not due to an ACTH-secreting pituitary tumor
Patients who have undergone major surgery including pituitary surgery within 1 month of screening or who have any major surgical procedures planned across the study period
Patients with serum potassium \< 3.5 mEq/L unless stably controlled on potassium supplementation
Patients with poorly-controlled Diabetes mellitus evidenced by HbA1c levels \>8
Patients with poorly controlled hypertension (i.e. blood pressure ≥ 160/100 mm Hg)
Patients who have clinically significant cardiovascular impairment, as evidenced by the presence of bradycardia, ventricular tachycardia, history of myocardial infarction within past year, or any other cardiovascular impairment that may pose significant health risk in view of the investigator.
Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B and C, or chronic persistent hepatitis, or patients with ALT or AST \>1.5 x ULN, serum total bilirubin \>ULN, serum albumin \<0.67 x LLN at screening
Patients with renal disease or history of renal disease with creatinine clearance of 30 cm3/min or less and/or creatinine \> 1.5 mg/dl at screening
Patients not biochemically euthyroid. Patients receiving thyroid-replacement therapy must be on a stable dose for at least 3 months.
Patients who are known to be positive for HIV, or any other condition that significantly compromises subject's immune system.
History of alcohol abuse or illicit substance use within past year.
Female patients who are pregnant or lactating or are of childbearing potential unless willing to practice acceptable method of birth control. Women participating in the trial must employ double barrier method through oral contraceptive or diaphragm with partner utilizing a condom. Abstinence is an acceptable form of birth control if routinely practiced. Male participants must utilize a condom with spermicidal cap/jelly and agree to not donate sperm for up to 3 months beyond main study period.
Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to screening or within 5 half-lives of the investigational treatment whichever is longer.
Patients with concomitant treatment of strong CYP3A4 inducers or inhibitors.
Patients who have received pituitary irradiation within the last 5 years prior to the baseline visit
Patients with known hepatitis B surface antigen (HbsAg) positivity
Patients with known hepatitis C antibody (anti-HCV) positivity

What this trial measures

  • Number of participants with mUFC ≤ 1.0xULNBaseline, 4 weeks

    4 week UFC calculated as the mean of three 24h UFC specimens collected on consecutive days between day 24-28