Status:
COMPLETED
SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome
Lead Sponsor:
Sparrow Pharmaceuticals
Conditions:
Cushing's Syndrome I
Cushing Disease Due to Increased ACTH Secretion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 subje...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05307328
Start Date
September 1 2022
End Date
August 1 2025
Last Update
October 8 2025
Active Locations (12)
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1
St. Joseph's Hospital and Medical Center - Barrow Neurological Institute (BNI) - Pituitary Center
Phoenix, Arizona, United States, 85013
2
Southwest General Healthcare Center
Fort Myers, Florida, United States, 33907
3
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, United States, 55905
4
Washington University School of Medicine - Center for Advanced Medicine (CAM)
St Louis, Missouri, United States, 63110