SPI-62 As A Treatment For Hypercortisolism Related To A Benign Adrenal Tumor

Overview

About this study

The purpose of this study is to evaluate the effectiveness, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 Criteria:

  • Diagnosis of ACTH-dependent Cushing's syndrome, pheochromocytoma, aldosterinoma, 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/1.73m^2 ).
  • 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 coronovirus 2 infection within 4 weeks, or hospitalization for Coronovirus 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.

Eligibility last updated 4/26/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Irina Bancos, M.D., M.S.

Closed for enrollment

Contact information:

Vanessa Fell

5072666068

fell.vanessa@mayo.edu

More information

Publications

Publications are currently not available