Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment...
Cushing's SyndromeThis study will evaluate whether the drug mifepristone can improve the symptoms of Cushing's syndrome in people with ectopic adrenal corticotrophin hormone (ACTH) secretion. Cushing's syndrome occurs when the adrenal glands produce too much cortisol, a hormone that helps to regulate the body's use of salt and food. Excessive cortisol is usually the result of too much ACTH, the hormone that causes the adrenal glands to make cortisol. The extra ACTH is made either by a tumor in the pituitary gland (called Cushing's disease) or by a tumor somewhere else (called ectopic ACTH secretion). Mifepristone blocks the action of cortisol in the body. The drug has been used safely to treat a few people with Cushing's syndrome and patients with certain kinds of cancer, gynecological diseases and psychiatric disorders. People between 18 and 85 years of age with Cushing's syndrome caused by EXCESS ACTH secretion may be eligible for this study. Candidates are admitted to the hospital for evaluation to confirm Cushing's syndrome and to determine its cause. The evaluation includes blood and urine tests, imaging tests, dexamethasone and corticotropin-releasing hormone tests and inferior petrosal sinus sampling. Patients determined to have Cushing's syndrome due to ECTOPIC ACTH secretion undergo imaging studies (CT, MRI and a nuclear medicine scan) and begin mifepristone therapy. Participants remain in the hospital for the following tests and procedures: Physical examination, electrocardiogram (EKG) and blood and urine tests Completion of medical questionnaires DEXA scan to determine bone mineral density and body composition Glucose tolerance test Urine pregnancy test and ultrasound to measure uterine lining thickness (for women) Patients take mifepristone by mouth 3 times a day. The dose is increased every week or so until symptoms improve or the highest dosage allowed is reached. Patients may remain in the hospital for all or part of the dose-finding part of the study. During this period (usually 2 to 4 weeks), blood pressure, glucose tolerance and blood chemistries are measured and EKG and urinalysis done every 5 to 14 days. When the mifepristone dose is stable patients remain on that dose for at least 2 weeks and are then re-evaluated. Patients then return to the hospital for evaluations every 3 months. Those who do well on the drug may continue to take it for up to 12 months.
Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin
Pancreatic NeoplasmPituitary Neoplasm2 moreThis study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.
A Prospective Cohort Study for Patients With Adrenal Diseases
Adrenal AdenomaCushing Syndrome4 moreThe purpose of this study is to investigate the pathologic features, complications, and prognostic factors of functioning adrenal adenoma and suggest follow-up algorithms for adrenal incidentaloma.
Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran...
Cushing SyndromeNeoplasmsThe primary objective is to determine the effect of relacorilant on the pharmacokinetics (PK) of the sensitive P-glycoprotein (P-gp) substrate dabigatran etexilate.
A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's...
Endogenous Cushing's SyndromeThis is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushing's Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole.
Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome
Cushing's SyndromeEctopic Corticotropin Syndrome4 moreThe study aim was to investigate the efficacy and safety of Osilodrostat in patients with Cushing's syndrome due to causes other than Cushing's disease in Japan.
Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
Cushing's SyndromeCushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from cortisol overproduction by the adrenal glands is the subject of this protocol. Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic administration of high doses of glucocorticoids, were not eligible for enrollment in this study. The purpose of this study was to evaluate the safety and efficacy of CORT125134 for treatment of endogenous Cushing's syndrome. The multicenter study was conducted in the United States and in Europe.
Treatment for Endogenous Cushing's Syndrome
Endogenous Cushing's SyndromeThe primary objectives of this study are to evaluate the clinical responder rate, defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of hypercortisolism.
Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism...
Mild HypercortisolismThe purpose of this study is to determine whether mifepristone is an effective treatment for hyperglycemia due to mild hypercortisolism. To test the hypothesis that GR blockade with mifepristone will decrease the severity of metabolic syndrome features as measured by waist circumference, lipid profile, body mass index, blood pressure and insulin resistance, measured by HOMA-IR score. To test the hypothesis that GR blockade with mifepristone will improve QoL, depression and anxiety scores, measured by validated assessments, in patients with mild hypercortisolism.
A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome
Cushing's SyndromePatients will receive Corlux (mifepristone) daily for up to 24 weeks. Assessments of the signs and symptoms of Cushing's syndrome will be obtained.