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New treatment option for Cushing Disease
Official title Fimepinostat, Combination HDAC and Pi3-kinase Inhibitor Tumor-Directed Therapy for Cushing Disease
ClinicalTrials.gov ID: NCT05971758
What this study is testing
What is Fimepinostat?
Fimepinostat is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for cushing disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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:
- Persistent hypercortisolism defined as a mean of 3 consecutive 24h UFC at baseline assessment ≥ 1.3x ULN
- Normal or elevated plasma ACTH levels
- Pituitary adenoma \> 4mm visible on MRI or inferior petrosal sinus sampling (IPSS) central to peripheral ACTH gradient \>2 at baseline and/or \>2...
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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:
- Persistent hypercortisolism defined as a mean of 3 consecutive 24h UFC at baseline assessment ≥ 1.3x ULN
- Normal or elevated plasma ACTH levels
- Pituitary adenoma \> 4mm visible on MRI or inferior petrosal sinus sampling (IPSS) central to peripheral ACTH gradient \>2 at baseline and/or \>2 after DDAVP stimulation.
- Recurrent or persistent CD defined as pathologically confirmed previously resected pituitary ACTH-secreting tumor, and 24 hour UFC \>ULN at least 4 weeks after pituitary surgery.
- Patients on medical treatment for CD. Washout periods will be completed as below before screening: Inhibitors of steroidogenesis (metyrapone, ketoconazole, osilodristat,
- 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.