Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
Trial Parameters
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: * Male and female patients at least 18 years old * Patients with confirmed pituitary origin of excess adrenocorticotropic hormone (ACTH) production: * Persistent hypercortisolemia established by two consecutive 24-hour UFC assessment ≥1.5× the upper limit of normal * Normal or elevated ACTH levels * Pituitary adenoma (\>1 cm) on MRI or inferior petrosal sinus sampling (IPSS) central to peripheral ACTH gradient \>2 at baseline and \>3 after CRH stimulation * Recurrent or persistent CD defined as pathologically confirmed resected pituitary ACTH-secreting tumor or IPSS central to peripheral ACTH gradient \>2 at baseline and \>3 after CRH stimulation, and 24h-UFC \>ULN beyond post-surgical week 6 * Patients on medical treatment for Cushing disease. The following washout periods must be completed before screening assessments are performed: * Inhibitors of steroidogenesis: metyrapone, ketoconazole: 2 weeks; Levoketoconazole: 3 weeks; osilodrostat: 6 weeks * Somatostatin r