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

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)

Detailed Description:
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 29 subjects will be treated with up to 800 mg/day oral seliciclib for 4 days each week for 4 weeks and enrolled in sequential cohorts based on efficacy outcomes. The study will also evaluate effects of seliciclib on quality of life and clinical signs and symptoms of Cushing disease.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 29 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
Actual Study Start Date: November 2, 2018
Estimated Primary Completion Date: November 2022
Estimated Study Completion Date: November 2022

Arm:
- Experimental: Seliciclib