Spots Global Cancer Trial Database for Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
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Trial Identification
Brief Title: Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
Official Title: A Phase 2 Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
Study ID: NCT03774446
Conditions
Interventions
Study Description
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 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars-Sinai Medical Center, Los Angeles, California, United States
Contact Details
Name: Shlomo Melmed, MD
Affiliation: Cedars-Sinai Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Ning-Ai Liu, MD, PhD
Affiliation: Cedars-Sinai Medical Center
Role: STUDY_DIRECTOR
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