Cyclin E-Mediated Human Proopiomelanocortin Regulation as a Therapeutic Target for Cushing Disease.
Ning-Ai Liu, Takako Araki, Daniel Cuevas-Ramos...
https://pubmed.ncbi.nlm.nih.gov/25942479Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID03774446
A Phase 2 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of oral seliciclib in people with newly diagnosed, persistent, or recurrent Cushing disease. This phase 2, open-label, multicenter trial aims to understand how seliciclib impacts quality of life and the clinical signs and symptoms of this condition. The study involves patients who have confirmed pituitary-related excess production of adrenocorticotropic hormone (ACTH). Participants will receive 80 mg of oral seliciclib daily for 4 weeks. Up to 13 people will be treated in this trial. The study measures changes in hormone levels and other health indicators before and after treatment, including tumor size and quality of life. This trial does not include a placebo group and is open-label, meaning both participants and researchers know the treatment being given. During the study, participants will undergo assessments including blood and saliva tests for hormone levels, MRI scans to check tumor size, visual field exams, and quality of life questionnaires. Researchers will monitor urinary free cortisol levels to assess treatment effects. Safety will be tracked through recording adverse events. The total participation time is 4 weeks, with evaluations at the start and end of treatment.
CONDITIONS
Brief Title
Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male and female patients at least 18 years old
- Confirmed pituitary origin of excess adrenocorticotropic hormone (ACTH) production
- Persistent hypercortisolemia shown by two consecutive 24-hour urinary free cortisol assessments at least 1.5 times the upper limit of normal
- Normal or elevated ACTH levels
- Presence of pituitary adenoma larger than 1 cm on MRI or specific ACTH gradient on inferior petrosal sinus sampling
- Recurrent or persistent Cushing disease confirmed by pathology or testing
- Completion of required washout periods from certain medications affecting steroidogenesis or liver enzymes before screening
You will not qualify if you...
- Patients with unstable or compromised visual fields
- Compression of optic chiasm with normal visual fields
- Cushing's syndrome not caused by pituitary ACTH secretion
- Hypercortisolism due to adrenal tumors or bilateral adrenal hyperplasia
- Known inherited syndromes causing hormone oversecretion
- Diagnosis of glucocorticoid-remedial aldosteronism
- Cyclic or pseudo-Cushing's syndrome
- Major surgery within 1 month before screening
- Low serum potassium below 3.5 despite replacement
- Poorly controlled diabetes (HbA1C over 8%)
- Significant cardiovascular impairment or risk
- Liver disease or abnormal liver tests
- Estimated glomerular filtration rate below 45 mL/min/1.73 m2
- Not biochemically euthyroid
- Medical conditions interfering with study or results
- Pregnancy or lactation without proper contraception
- Recent participation in other investigational drug trials or prior seliciclib treatment
- Ongoing medical treatment for Cushing disease
- Recent pituitary irradiation or radionuclide treatment
- Known allergy to seliciclib
- History of non-compliance or unreliability
- Positive hepatitis B or C tests
- Prolonged QTcF interval on ECG over 450 milliseconds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants take oral seliciclib once daily to evaluate its safety and efficacy for Cushing disease.
Baseline visit and 1 follow-up visit at week 4
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
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Research Team
D
Daniel Gomez
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Targeting zebrafish and murine pituitary corticotroph tumors with a cyclin-dependent kinase (CDK) inhibitor.
Ning-Ai Liu, Hong Jiang, Anat Ben-Shlomo...
https://pubmed.ncbi.nlm.nih.gov/21536883