Actively Recruiting
Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
Led by Cedars-Sinai Medical Center · Updated on 2025-09-11
13
Participants Needed
1
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase 2 multicenter, open-label clinical trial will evaluate safety and efficacy of 4 weeks of oral seliciclib in patients with newly diagnosed, persistent, or recurrent Cushing disease. Funding Source - FDA Office of Orphan Products Development (OOPD)
CONDITIONS
Official Title
Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients at least 18 years old
- Confirmed pituitary origin of excess ACTH production
- Persistent hypercortisolemia established by two consecutive 24-hour UFC assessments 1.5 times the upper limit of normal
- Normal or elevated ACTH levels
- Pituitary adenoma (>1 cm) on MRI or central to peripheral ACTH gradient >2 at baseline and >3 after CRH stimulation by IPSS
- Recurrent or persistent Cushing disease confirmed by pathology or IPSS criteria with 24-hour UFC above upper limit of normal beyond 6 weeks post-surgery
- Completion of required washout periods from steroidogenesis inhibitors, somatostatin receptor ligand pasireotide, progesterone receptor antagonist mifepristone, dopamine agonist cabergoline, and CYP3A or CYP2B6 strong inducers or inhibitors before screening
You will not qualify if you...
- Compromised or unstable visual fields for at least 6 months
- Abutment or compression of the optic chiasm on MRI with normal visual fields
- Cushing's syndrome due to non-pituitary ACTH secretion
- Hypercortisolism caused by adrenal tumors or nodular bilateral adrenal hyperplasia
- Known inherited syndromes causing hormone oversecretion (e.g., Carney Complex, McCune-Albright syndrome, MEN 1)
- Diagnosis of glucocorticoid-remedial aldosteronism
- Cyclic Cushing's syndrome with normal UFC measurements within the last month
- Pseudo-Cushing's syndrome due to uncontrolled depression, anxiety, OCD, morbid obesity, alcoholism, or uncontrolled diabetes
- Major surgery within 1 month prior to screening
- Serum potassium below 3.5 despite replacement treatment
- Poorly controlled diabetes with HbA1C over 8%
- Significant cardiovascular impairment or risk (e.g., congestive heart failure NYHA III-IV, unstable angina, recent heart attack)
- Liver disease or abnormal liver enzymes at screening or advanced liver fibrosis
- Estimated glomerular filtration rate below 45 mL/min/1.73 m2
- Not biochemically euthyroid
- Conditions interfering with study conduct or safety, including immunocompromise, active infection, or recent alcohol misuse
- Pregnant or lactating women or women of childbearing potential not using acceptable contraception
- Participation in investigational drug studies within 1 month or prior seliciclib treatment
- Ongoing or anticipated additional treatments for Cushing disease
- Pituitary irradiation within last 5 years
- Prior radionuclide treatment
- Known allergy to seliciclib
- History of non-compliance or inability to complete the study
- Positive hepatitis B surface antigen or hepatitis C antibody
- Prolonged QTcF interval (>450 msec) on ECG screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
D
Daniel Gomez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here