Phase 2 Multicenter Study Evaluating Oral Seliciclib for Treating Cushing Disease

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.

Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease