Clinical trial NCT05307328: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cushing's Syndrome I
Cushing Disease Due to Increased ACTH Secretion
Cortisol Excess
Cortisol; Hypersecretion
Cortisol Overproduction
Ectopic ACTH Secretion
Keywords: Cushing's Syndrome
ACTH Secretion
Cushing's Disease
Excessive Cortisol secretion
Cortisol
ectopic CRH secretion
Lead sponsor: Sparrow Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-04-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Staggered parallel crossover
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

* Male or non-menstruating female
* 18 years or older
* Active and consistent cortisol excess
* Documented diagnosis of ACTH-dependent Cushing's syndrome including Cushing's disease, ectopic ACTH secretion, and ectopic CRH secretion.

Exclusion Criteria:

* Recent (within 6 weeks) surgery for Cushing's or surgery planned within 24 weeks of randomization.
* History of any fractionated radiation therapy for Cushing's within the past 2 years or conventional radiation therapy within 4 years.
* History of bilateral adrenalectomy or exogenous, pseudo, cyclic, or non-ACTH-dependent Cushing's syndrome (including certain inherited conditions).
* High risk of acute morbidity from corticotroph adenoma growth (similar to that which occurs with Nelson's syndrome) defined as current evidence of macroadenoma at risk of impingement of vital structures.
* Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results, including but not limited to poor venous access or recent receipt or donation of blood products.
* Women who are currently pregnant, lactating or planning fertility and unwilling to adhere to approved contraceptives or abstinence.

Primary outcomes:
measure: Change from baseline in urinary HSD-1 ratio
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Treatment emergent adverse events
timeFrame: Baseline through 24 weeks of treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center - Barrow Neurological Institute (BNI) - Pituitary Center
state: Arizona
city: Fort Myers
country: United States
facility: Southwest General Healthcare Center
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center (MCCC) - Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Center for Advanced Medicine (CAM)
state: Missouri
city: Henderson
country: United States
facility: Comprehensive and Interventional Pain Management Llp
state: Nevada
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU) - Northwest Pituitary Center
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Plovdiv
country: Bulgaria
facility: Medical University of Plovdiv
city: Sofia
country: Bulgaria
facility: Clinical Center of Endocrinology and Gerontology, University Hospital of Endocrinology, Medical University Sofia (USHATE)
city: Sofia
country: Bulgaria
facility: Medical University of Sofia
city: Bucharest
country: Romania
facility: Carol Davila University of Medicine and Pharmacy
Study officials:
affiliation: Sparrow Pharmaceuticals (info@sparrowpharma.com)
name: Frank Czerwiec, MD
role: STUDY_DIRECTOR
References: