Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
ConditionCushing Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center
About this trial
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
Qualifiers
Male and female patients at least 18 years old
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
Disqualifiers
Patients with compromised visual fields, and not stable for at least 6 months
Patients with abutment or compression of the optic chiasm on MRI and normal visual fields
Patients with Cushing's syndrome due to non-pituitary ACTH secretion
Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia
Trial design
Treatments tested in this trial
- Seliciclib
Treatment groups
13 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov