Status:
TERMINATED
SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
Lead Sponsor:
Sparrow Pharmaceuticals
Conditions:
Autonomous Cortisol Secretion (ACS)
ACTH-Independent Cushing Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is study with SPI-62 to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor. Each subject will receive 2mg of S...
Detailed Description
This is a multicenter, open-label, single-arm study, Phase 2 study to estimate SPI-62's effect on clinical features of hypercortisolism related to a benign adrenal tumor, including diabetes/impaired g...
Eligibility Criteria
Inclusion
- Diagnosis and main criteria for inclusion and exclusion:
- The following are the main inclusion criteria:
- Adults able to provide informed consent.
- Documented characteristically benign adrenal nodule, with diameter ≤ 4 cm, homogenous texture, and non-contrast computerized tomography ≤ 20 HU attenuation or proven to be non malignant.
- Diagnosis of diabetes mellitus, pre-diabetes or impaired glucose tolerance, either untreated or on stable standard of care treatment, based on at least one of:
- HbA1c ≥ 5.7% but not \> 9.5%
- 2-hour glucose level ≥ 7.8 mmol (140 mg/dL) on a 75 g OGTT
- At least one additional documented cortisol-related morbidities, either untreated or on stable standard of care treatment:
- hypercholesterolemia with total cholesterol \> 3.9 mM (150 mg/dL);
- hypertriglyceridemia with triglycerides \> 2.3 mM (200 mg/dL);
- osteopenia with bone densitometry Z-score \< -2.0 or T-score \< -1.0;
- history or evidence of minimally traumatic or osteoporotic fracture; or
- hypertension with resting supine blood pressure \> 130 but \< 180 mmHg systolic or \> 85 but \< 120 mmHg diastolic.
- Poorly suppressible hypercortisolemia:
- Morning serum cortisol \> 50 nM (1.8 mcg/dL) after a 1 mg ONDST.
- Subjects with dexamethasone \< 3.3 nmol/L (130 ng/dL) will undergo a high-dose (8 mg) ONDST.
- Subjects who take estrogen-containing medicines will be evaluated based on free cortisol \> 2.2 nM (80 ng/dL).
- For subjects with morning serum cortisol \> 138 nM (5.0 mcg/dL) after ONDST, the Investigator will assess for adrenal Cushing's syndrome.
Exclusion
- Diagnosis of ACTH-dependent Cushing's syndrome, pheochromocytoma, aldosteronoma, adrenocortical carcinoma, or congenital adrenal hyperplasia, or other malignancy associated hypercortisolism including history of adrenal carcinoma.
- History of adrenalectomy or planned adrenalectomy within 4 months after randomization.
- Exogenous hypercortisolism.
- Uncontrolled, clinically significant hypo- or hyperthyroidism.
- History of idiopathic thrombocytopenia.
- Moderately impaired renal function (estimated glomerular filtration rate \< 60 mL/min/1.73m2).
- History of cancer (other than non-melanoma skin, thyroid, or early-stage prostate cancer) within 3 years.
- Any major surgery, or significant post-operative sequelae, within 1 month prior to informed consent or planned during the trial.
- Pregnant or lactating.
- Positive test for severe acute respiratory syndrome coronavirus 2 infection within 4 weeks, or hospitalization for Coronavirus disease 2019 within 6 months, prior to randomization.
- Any other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results.
- Participation in any clinical trial within 3 months prior to the first dose of study drug, or longer depending on half-life of the investigational therapy.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05436639
Start Date
July 1 2023
End Date
February 18 2025
Last Update
February 26 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, United States, 55905
2
Ohio State McCampbell Outpatient Care
Columbus, Ohio, United States, 43210
3
C.M.D.T.A. Neomed
Brasov, Romania, 500283
4
Institutul National de Endocrinologie
Bucharest, Romania, 11863