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

StatusRecruiting
PhasePhase 2
Started2018-11-02
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 11, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-09-09
Study Status, Oversight v8
Primary completion date2025-08→2026-08
Completion date2025-08→2026-08
2024-09-11
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 1 site
2023-09-10
Active, Not Recruiting→Recruiting Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v6
Trial statusActive, Not Recruiting→Recruiting
Enrollment target29→13
Eligibility criteria+928 characters
Inclusion criteriaCriteria: Male and female patients at least 18 years old Patients wi [...] rsistent hypercortisolemia established by two consecutive 24 h-hour UFC levelsassessment at least ≥1.5x5× the upper limit of normal Normal or elevated ACTH levels Pituitary macroadenomaadenoma (>1 cm) on MRI or inferior petrosal sinus sampling (IPSS) c [...] ral to peripheral ACTH gradient >2 at baseline and >3 after corticotropin-releasing hormone (CRH) stimulation Recurrent or persistent Cushing diseaseCD defined as pathologically confirmed resected pituitary ACTH [...] H gradient >2 at baseline and >3 after CRH stimulat [...]
Study description-143 characters
This phase 2 multicenter, open-label clinical trial will evaluate safety and efficacy of two of three potential doses/schedules of oral seliciclib in patients with newly diagnosed, persistent, or recurrent Cushing disease. Up to 2913 subjects will be treated with up to 80080 mg/day oral seliciclib for 4 days each weekday for 4 weeks and enrolled in sequential cohorts based on efficacy outcomes. The study will also evaluate effects of seliciclib on qual [...]
Study sitesdetails revised at 1 of 1 site
2023-06-15
Study Status v5
Primary completion date2025-03→2025-08
Completion date2025-03→2025-08
2022-05-24
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2022-11→2025-03
Completion date2022-11→2025-03
Study sitesdetails revised at 1 of 1 site
Show 3 earlier versions
2021-04-21
Study Status, Study Design, Contacts/Locations v3
Study sitescontacts updated at 1 of 1 site
2020-01-21
Study Status v2
Re-verified, no change to tracked fields
2019-11-26
Study Status, Eligibility v1
Eligibility criteria+316 characters
[...] ologically confirmed resected pituitary ACTH-secreting tumor or IPSS central to peripheral ACTH gradient >2 at baseline and >3 after CRH stimulation, and 24 hour UFC above the upper limit of normal reference [...] l week 6 Patients on medical treatment for Cushing disease. WashoutThe following washout periods must be completed before screening assessments are performed.: Inhibitors of steroidogenesis (metyrapone, ketoconazole): 2 weeks Somatostatin receptor ligand pasireotide: short-acting, 2 weeks; long-acting, 4 weeks Progesterone receptor antagonist (mifepristone): 2 weeks Dopamine agonists (cabe [...] [...]
2018-12-11
Original filing
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)
Trial Details
NCT Number NCT03774446
Lead Sponsor Cedars-Sinai Medical Center
Conditions Cushing Disease
Enrollment 13 participants
Start Date 2018-11-02
Primary Completion 2026-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2025-09-11