A Phase 2 Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
Cedars-Sinai Medical Center
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)
Description
This phase 2 multicenter, open-label clinical trial will evaluate safety and efficacy of oral seliciclib in patients with newly diagnosed, persistent, or recurrent Cushing disease. Up to 13 subjects will be treated with 80 mg each day for 4 weeks. The study will also evaluate effects of seliciclib on quality of life and clinical signs and symptoms of Cushing disease.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 IP…
Interventions
- DrugSeliciclib
Drug: Seliciclib
Location
- Cedars-Sinai Medical CenterLos Angeles, California