EUCTR2016-000899-23-NL进行中（未招募）1 期
Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing’s Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Is a male or female adult, 18–80 years of age
- •2. Has a diagnosis of endogenous Cushing’s syndrome confirmed by:
- •At least two of the following test criteria (Nieman 2008):
- •Urinary free cortisol above the upper limit of normal (ULN) (50.0 µg/24 h) in at least 2, and up to 4, complete 24 hour collections within 3 weeks prior to Day 1 (baseline)
- •Late-night salivary cortisol above the ULN (at least 2, and up to 4, collections using a salivette) within 3 weeks prior to Day 1 (baseline)
- •Lack of cortisol suppression (>1.8 µg/dL serum cortisol) on either 1 mg overnight or 2-mg 48 hour dexamethasone suppression testing during screening or within 12 weeks before the ICF is signed.
- •At least two of the following clinical signs and symptoms of Cushing’s syndrome:
- •Facial characteristics of a Cushingoid appearance (moon facies, dorsocervical fat pad, plethora)
- •Increased body weight or central obesity
- •Proximal muscle weakness
- •Low bone mass (dual energy X-ray absorptiometry [DXA] T < -1.0)
- •Psychiatric symptoms (including depression or psychosis)
- •Hirsutism and/or violaceous striae and/or acne
- •Easy bruising
- •A patient with an adrenal lesion may alternatively qualify if there is autonomous cortisol secretion based on dexamethasone suppression testing (Fassnacht 2016) and supporting evidence of clinically significant cortisol excess. Such a patient must have:
- •Radiologically proven unilateral or bilateral adrenal disease (nodules, hyperplasia)
- •Lack of cortisol suppression (>5 µg/dL serum cortisol) on either 1-mg overnight or 2-mg 48-hour dexamethasone suppression testing during screening
- •Low or suppressed ACTH (<10 pg/mL) to confirm ACTH-independency
- •Presence of at least two comorbidities potentially related to cortisol excess (eg, type 2 diabetes, hypertension, obesity, osteoporosis), of which at least one is inadequately controlled by medical measures
- •3. Requires medical treatment of hypercortisolemia (i.e. those for whom surgery or radiation is contraindicated or has been refused)
- •Examples include, but are not limited to, patients with Cushing’s disease who are post-surgery and/or post-radiation for whom additional surgery is not recommended; de novo patients with Cushing’s disease who are not eligible for surgery due to comorbidities; and patients with ectopic ACTH-dependent Cushing’s syndrome in which the tumor cannot be localized or completely removed.
- •4. Meets at least one of the following criteria:
- •Has type 2 diabetes mellitus as confirmed at screening visit with a fasting glucose >126 mg/dL and a 2-hour oral glucose tolerance test [oGTT] result for plasma glucose =200 mg/dL at 2 hours (Standards of Medical Care in Diabetes – 2015)
- •Has impaired glucose tolerance (2-hour oGTT result for plasma glucose in the range of = 140 mg/dL to <200 mg/dL) (Standards of Medical Care in Diabetes – 2015)
- •Has hypertension (mean systolic BP of 130–170 mmHg and/or a mean diastolic BP of
- •85–110 mmHg) based on 24 hour ambulatory BP measurement (O’Brien 2013)
- •5. If taking antidiabetic medication, is on a stable dose (i.e. cannot start new medication or change dose within 4 weeks prior to the first dose of study drug)
- •6. If taking antihypertensive medication, is on a stable dose (i.e. cannot start new medication or change dose within 4 weeks prior to the screening ambulatory BP measurement)
- •7. Has potassium within the normal range (3.5–5.3 mEq/L) at screening or corrected to within the normal range by Day 1
排除标准
- •1. Has a non-endogenous source of hypercortisolemia
- •2. Has pseudo-Cushing’s syndrome. Patients with known or suspected pseudo-Cushing’s syndrome based on medical history (such as patients with severe obesity, major depression, or a history of alcoholism) should undergo a dexamethasone-CRH/DDAVP stimulation test (Yanovski 1993, Giraldi 2007, Yanovski 1998) to rule-in or rule-out this possibility.
- •3. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
- •4. Has poorly controlled hypertension, defined as systolic BP >170 mmHg or diastolic BP >110 mmHg at screening
- •5. Has Stage 4 renal failure (ie, glomerular filtration rate =29 mL/min)
- •6. Has elevated total bilirubin >1.5×ULN or elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3×ULN
- •7. For patients with diabetes or abnormal oGTT at screening: Has glycated hemoglobin (HbA1c) of >12% within 3 months of first dose of study drug
- •8. Has a screening hemoglobin level of <9 g/dL
- •9. Has a clinically significant electrocardiogram (ECG) abnormality at screening, which, in the opinion of the Investigator, will make the patient an unsuitable candidate for the study
- •10. Has a confirmed screening QTcF interval >450 ms for males and >470 ms for females (using Fridericia’s correction) in the presence of a normal QRS interval (QRS <120 ms) or a history of additional risk factors for torsades de pointes
- •11. Is currently receiving chemotherapy for a tumor related to Cushing’s syndrome
- •12. Had radiation therapy for Cushing’s syndrome-related tumor within 1 year of screening period
- •13. Is planning surgery or radiation therapy for Cushing’s syndrome-related tumor during the study
- •14. Has used or plans to use any of the following treatments for Cushing’s syndrome, as specified:
- •Adrenostatic medications: metyrapone, ketoconazole, fluconazole, aminoglutethimide, or etomidate from 4 weeks prior to baseline (Day 1) through the follow-up visit
- •Adrenolytic medications:
- •oIn Group 1, any patients taking mitotane
- •oIn Group 2 only, patients with adrenocortical carcinomas taking mitotane whose dose has not been stable for at least 2 months prior to baseline (Day 1) or in whom increases in the mitotane dosage are expected through the end of dosing
- •Neuromodulator drugs that act at the hypothalamic-pituitary level: serotonin antagonists (cyproheptadine, ketanserin, retanserin), dopamine agonists (bromocriptine, cabergoline), gamma-aminobutyric acid agonists (sodium valproate), and somatostatin receptor ligands (octreotide long-acting release [LAR], pasireotide LAR, lanreotide) from 8 weeks before baseline (Day 1) through the follow-up visit. Use of short-acting somatostatin analogs (octreotide, pasireotide) from 4 weeks prior to baseline (Day 1) through the follow-up visit.
- •Mifepristone, from 6 weeks before baseline (Day 1) through the follow-up visit
- •15. Has started or increased (or plans to start or increase) the dose of an antidepressant medication (eg, selective serotonin reuptake inhibitors or tricyclic compound) from 6 weeks before baseline (Day 1) through the end of the study dosing period
- •16. Has started or increased (or plans to start or increase) the dose of a lipid-lowering drug from 4 weeks before baseline (Day 1) through the follow-up visit
- •17. Is lactating
- •18. Has an acute or unstable medical problem that could be aggravated by treatment with the investigational study drug
- •19. Has a history of hypersensitivity or severe reaction to th
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