EUCTR2018-001616-30-IT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 -
相关药物
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
- •All Patients
- •1. Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome through the treatment period with at least 80% adherence with scheduled dosing and visits.
- •2. According to Investigator's opinion will benefit from continuing 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 30 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 30 days after
- •the last dose of study drug. Highly effective methods of contraception include abstinence, oral contraceptives combined with a barrier method,
- •diaphragm with vaginal spermicide, intrauterine device, male condom and partner using vaginal spermicide, and surgical sterilization (=6
- •months postsurgery).
- •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. Mitotane is acceptable in patients with adrenal carcinoma.
- •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 (obtained up to 3 months before to 6 weeks after start of treatment in this study) to assess changes in tumor size during dosing.
- •Patients Who Enter Study >8 Weeks After Completing the Parent Study
- •8. Have a diagnosis of endogenous Cushing syndrome confirmed by 2 of the 3 following biochemical test criteria:
- •Urinary free cortisol above the upper limit of normal (ULN) (50.0 µg/24 h) in at least 2 complete 24-hour collections within 3 weeks before Day 1.
- •Late-night salivary cortisol above the ULN in at least 2 collections using a salivette within 3 weeks before Day 1.
- •Results from the dexamethasone suppression test performed during the parent study.
- •Patients requiring washout of a medication for Cushing syndrome must complete the screening 24-hour UFC tests and salivary cortisol tests after a minimum washout of 2 weeks for adrenostatic medications and short-acting somatostatin analogs, 4 weeks for mifepristone and dopamine agonists, and 6 weeks for long-acting somatostatin ligands
- •and within 3 weeks before Day 1 dosing.
- •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 21
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
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.
- •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, ketoconazole, fluconazole,aminoglutethimide, or etomidate 2 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.
- •Mifepristone, from 4 weeks before Day 1 through the end of this study.
- •Strong CYP3A4 inhibitors (including grapefruit, grapefruit juice, or grapefruit-containing products) during treatment with relacorilant.
- •5. Plan to use systemic, potent (Group III), and potent intra-articular corticosteroids 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.
- •7. Have a history of an allergic reaction or intolerance to relacorilant.
- •8. Have uncorrected hypokalemia (potassium level of < 3.5 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) >450 ms for males and >470 ms for females in the presence of a normal QRS interval (QRS <120 ms) or a history of additional risk factors for torsades de pointes.
- •14. Women of childbearing potential: are pregnant based on serum pregnancy test.
- •15. Have an ongoing SAE that started in the parent study.
研究者
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