NCT03774446

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

A Phase 2 Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Cushing Disease

Interventions

Type	Name	Description
DRUG	Seliciclib	Drug: Seliciclib

Timeline

• Start date: 2018-11-02
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2018-12-13
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study