NCT03621280已完成3 期
An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Cortendo AB
- 入组人数
- 51
- 试验地点
- 30
- 主要终点
- Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
研究概览
简要总结
This is a long-term, open-label extension study of levoketoconazole in participants with endogenous Cushing's Syndrome.
详细描述
This is a long-term, open-label extension (OLE) study of levoketoconazole in participants with endogenous Cushing's Syndrome (CS) who have completed one or both parent studies or otherwise potentially qualify for this study, as defined in the eligibility criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the Extended Evaluation Phase of Study COR-2012-01 (i.e. M12)
- •Completed the Restoration Phase of Study COR-2017-01 (i.e. RES2)
- •NOTE: Participants meeting criteria 1 or 2 above who have had a break in therapy may be eligible only after discussion with the Medical Monitor. If eligible, such participants may require re-establishment of the Therapeutic Dose via titration. All participants who have had a break in therapy should be discussed with the Medical Monitor to determine the starting dose of levoketoconazole. Prior to resuming treatment with levoketoconazole, other therapies for Cushing's Syndrome must undergo an appropriate washout period, with minimum durations as follows:
- •Ketoconazole or metyrapone: 2 weeks;
- •Dopamine agonists: bromocriptine (2 weeks), cabergoline (8 weeks);
- •Octreotide acetate LAR, lanreotide Autogel, pasireotide LAR: 12 weeks;
- •Lanreotide SR: 8 weeks;
- •Octreotide acetate (immediate release) or short-acting pasireotide: 1 week;
- •Mifepristone (RU 486, KORLYM): 4 weeks;
- •Megestrol acetate or medroxyprogesterone acetate (and selected other synthetic progestins): 6 weeks.
- •Currently in a named patient program or other Expanded Access Program receiving levoketoconazole
- •Were levoketoconazole-naïve prior to entry and received early rescue therapy with open-label levoketoconazole in Study COR-2017-
- •Achieved a clinically meaningful partial response (with reduction of UFC) in Study COR-2017-01 at dose level 7 or at a maximally tolerated dose of levoketoconazole but did not meet the randomization criteria for Study COR-2017-01 at the end of the Dose Titration and Maintenance Phase when randomization was open.
- •Were levoketoconazole-naïve prior to entry and were enrolled in Study COR-2017-01 in the Dose Titration and Maintenance Phase when randomization was closed. (NOTE: Such subjects must receive at least 1 dose of levoketoconazole before transitioning to this study.)
排除标准
- •Discontinued levoketoconazole while participating in Study COR-2012-01 or Study COR-2017-01 or a named patient program or other Expanded Access program, due to safety or tolerability concerns or lack of efficacy.
- •Scheduled for surgery for treatment of CS or received surgery for treatment of CS within the 6 weeks prior to Screening.
- •Treated with mitotane within 6 months prior to enrollment.
- •History of malignancy, including adrenal or pituitary carcinomas (other than low-risk, well-differentiated carcinomas of thyroid, breast or prostate that are very unlikely to require further treatment in the opinion of the treating physician, or squamous cell or basal cell carcinoma of the skin).
研究组 & 干预措施
Levoketoconazole
Experimental
Levoketoconazole taken twice daily up to 1200 mg daily
干预措施: Levoketoconazole (Drug)
结局指标
主要结局
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
时间窗: From parent study Baseline to final study visit or up to a maximum of 3 years, whichever comes first.
Proportions of participants with mUFC: 1) Less or equal to the ULN of the reference range, 2) Above the ULN to 1.5x the ULN, and 3) Above 1.5x the ULN.
次要结局
未报告次要终点
研究者
研究点 (30)
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