EUCTR2018-001616-30-NL进行中（未招募）1 期
An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome - CORT125134-452
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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. Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome.
- •2. According to Investigator’s opinion will benefit from treatment with relacorilant.
- •3. Provide written informed consent.
- •4. If a female of childbearing potential, patients must be willing to use a highly effective method of contraception from 30 days before study entry until 28 days after the last dose of study drug. Male patients with a female partner must agree to 2 forms of contraception, one of which must be a double-barrier method, from study entry until 28 days after the last dose of study drug. Highly effective methods of contraception are detailed in the protocol.
- •5. Are willing to continue to refrain from using drugs that inhibit steroid biosynthesis by the adrenal cortex or ACTH secretion by a pituitary or extrapituitary ACTH secreting tumor.
- •6. Are able to return to the investigative site to complete the study evaluations outlined in the protocol.
- •7. For patients with Cushing syndrome due to an ACTH-secreting pituitary tumor, are able to obtain pituitary MRI imaging (up to 6 months before starting treatment in this study, or up to 6 weeks after start of treatment in this study) to assess changes in tumor size during dosing. A CT scan can be used instead in patients for whom MRI is contraindicated.
- •8. For patients entering the study >12 weeks after completing the last dose in the parent study, confirmation of hypercortisolism consistent with the criteria of the parent study is required.
- •9. For patients who received treatment for hypercortisolism after their last dose in the parent study, confirmation of hypercortisolism consistent with the criteria of the parent study is required.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Have been prematurely discontinued from relacorilant study treatment in the parent study for any reason
- •2. Are planning to start another Cushing syndrome drug after starting participation in this extension study.
- •3. Have an acute or unstable medical problem that could be aggravated by relacorilant treatment or has known active COVID-19 infection at Screening.
- •4. Are taking the following medications from the times specified below before the Study CORT125134-452 Day 1 visit and/or through the entire study period:
- •Medications used in the treatment of Cushing syndrome, with the exception of relacorilant, are prohibited:
- •– Adrenostatic medications: metyrapone, osilodrostat, ketoconazole, fluconazole, aminoglutethimide, or etomidate 4 weeks before Day 1 through the end of this study
- •– Neuromodulator drugs that act at the hypothalamic-pituitary level: serotonin antagonists (cyproheptadine, ketanserin, ritanserin), 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 Day 1 through the end of this study. Use of short-acting somatostatin analogs (octreotide, pasireotide) from 4 weeks before Day 1 through the end of this study.
- •Patients who require inhaled glucocorticoid use and have no alternative option if their condition deteriorates during the study.
- •Mifepristone, from 4 weeks before Day 1.
- •Ongoing use of any strong CYP3A4 inhibitors (including grapefruit, grapefruit juice, or grapefruit-containing products) or inducers during treatment with relacorilant.
- •Has used mitotane prior to Day 1.
- •Ongoing use of antidiabetic, antihypertensive, antidepressant, and/or lipid-lowering medications that are highly dependent on CYP3A for clearance and that cannot undergo dose modifications upon coadministration with strong CYP3A inhibitors.
- •5. Plans for prolonged regular use of systemic glucocorticoids from Day 1 through the end of the study.
- •6. Have received investigational treatment (drug, biological agent, or device) other than relacorilant within 4 weeks of study entry, or within 5 times the drug's half-life, whichever is longer.
- •7. Have a history of an allergic reaction or intolerance to relacorilant.
- •8. Have uncorrected clinically significant hypokalemia (potassium level of < 3 mEq/L) within 2 weeks before enrollment in this study (Day 1).
- •9. Have uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- •10. Have renal failure as defined by a serum creatinine of =2.2 mg/dL.
- •11. Have elevated total bilirubin >1.5 × the ULN or elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =3 × ULN.
- •12. Have a clinically significant ECG abnormality at baseline, which, in the opinion of the Investigator, will make the patient an unsuitable candidate for the study.
- •13. Have a confirmed baseline QT interval corrected using Fridericia’s formula (QTcF) of >450 ms for males and >470 ms for females in the presence of a normal QRS interval (QRS <120 ms), a QTcF interval >500 ms with a wide QRS interval (=120 ms),or a history of additional risk factors for torsades de pointes.
- •14. Has received stereotactic radiation therapy for a Cushing syndrome-related tumor within 24 months of Baseline or conventional pituitary radiation therapy within 36 months of Baseline.
- •15. Has undergone pituitary surgery <3 months prior to Screening.
- •16. Has plans for adrenalec
研究者
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