Spots Global Cancer Trial Database for SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome
Official Title: SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome
Study ID: NCT05307328
Study Description
Brief Summary: This is a randomized, placebo-controlled, study of SPI-62 in subjects with ACTH-dependent Cushing's syndrome caused by a non-adrenal tumor. Subjects will receive each of the following 2 treatments for 24 weeks: SPI-62 and matching placebo with the option of long-term extension.
Detailed Description: This is a multicenter, randomized, placebo-controlled, Phase 2 study to evaluate the pharmacologic effect, efficacy, and safety of SPI-62 in subjects with ACTH-dependent Cushing's syndrome. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in a screening period (Days -35 to -8), a baseline period (Days -7 to -1), and a treatment period (Day 1 of Week 1 to Day 168 ± 3 days of Week 24) and, the option of long-term extension. Subjects have the option to continue with the study on active study drug and return to the site every 3 months for blood tests and study drug dispensing. The visits may be conducted remotely if testing can be arranged.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Joseph's Hospital and Medical Center - Barrow Neurological Institute (BNI) - Pituitary Center, Phoenix, Arizona, United States
Southwest General Healthcare Center, Fort Myers, Florida, United States
Mayo Clinic Cancer Center (MCCC) - Rochester, Rochester, Minnesota, United States
Washington University School of Medicine - Center for Advanced Medicine (CAM), Saint Louis, Missouri, United States
Comprehensive and Interventional Pain Management Llp, Henderson, Nevada, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Oregon Health & Science University (OHSU) - Northwest Pituitary Center, Portland, Oregon, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Medical University of Plovdiv, Plovdiv, , Bulgaria
Clinical Center of Endocrinology and Gerontology, University Hospital of Endocrinology, Medical University Sofia (USHATE), Sofia, , Bulgaria
Medical University of Sofia, Sofia, , Bulgaria
Carol Davila University of Medicine and Pharmacy, Bucharest, , Romania
Contact Details
Name: Frank Czerwiec, MD
Affiliation: Sparrow Pharmaceuticals (info@sparrowpharma.com)
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
