This is a randomized, placebo-controlled, crossover study of SPI-62 in subjects with ACTH-dependent Cushing’s syndrome. Subjects will receive each of the following 2 treatments for 12 weeks: SPI-62 and matching placebo
Condition or disease
Intervention/treatment
Phase
Cushing’s Syndrome ICushing Disease Due to Increased ACTH Secretion Cortisol ExcessCortisol; Hypersecretion Cortisol Overproduction Ectopic ACTH Secretion
Drug: SPI-62 Drug: Placebo
Phase 2
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 3 periods: a 28-day screening period (Days -35 to -8), a 7-day baseline period (Days -7 to -1), and a 24-week treatment period (Day 1 of Week 1 to Day 168 ± 3 days of Week 24). Up to 26 subjects will be enrolled with the aim that 18 subjects with Cushing’s disease will complete the study. Subjects will receive each of the following 2 treatments for 12 weeks: SPI-62 and matching placebo.
Study Design
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Study Type :
Interventional (Clinical Trial)
Estimated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Staggered parallel crossover
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing’s Syndrome
Friday April 12, 2019
8:30am – 4:30pm
Zuckerman Research Center
417 E. 68th St. New York, NY
Memorial Sloan Kettering Cancer Center
This course is suited for medical professionals, patients, and caregivers to improve patient care and outcomes through evidence-based discussion of clinical practice guidelines and emerging therapies in order to assess and update current practices to promote earlier diagnosis and treatment of pituitary diseases. The multidisciplinary nature of the course will allow the dissemination of knowledge across the variety of practitioners caring for pituitary patients, as well as for patients and caregivers.
After completion of this educational activity, participants will be up-to-date on the latest in ongoing care and clinical management of patients with pituitary conditions. The patient breakout sessions will provide pituitary patients the ability to review treatment options, learn about ongoing clinical trials, and discuss their comprehensive care with providers and other patients.
Memorial Sloan Kettering Cancer Center is providing this course to pituitary patients and caregivers free of charge. To register to attend, please email cme@mskcc.org . (Please note: Registration is required in order to attend.)