EUCTR2019-004019-29-IT进行中（未招募）1 期
Medical combination therapy with retinoic acid and cabergoline in ACTH-secreting pituitary adenoma: a prospective and randomized study. - CRACCA
Dipartimento di Medicina-DIMED, università di Padova0 个研究点目标入组 60 人开始时间: 2020年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Age> 18 years at the enrollment visit
- •Diagnosis of Cushing's disease with at least one criterion between:
- •· Immunohistochemistry positive for ACTH of the pituitary adenoma
- •Center / periphery gradient> 3 for ACTH after CRH catheterization of the petrosal sinuses
- •· At least two positive tests between CRH response (ACTH> 50% from baseline), suppression of cortisol after high doses of dexamethasone (> 80% from baseline), pituitary MRI with adenoma = 6mm; remission of hypercorticism after pituitary surgery
- •. Biochemical hypercorticism before enrollment (mCLU> ULN)
- •. Adequate performance status: ECOG = 2
- •. Verbal and written informed consent of the patient before any screening procedure
- •· Patients who have already undergone transphenoidal surgery or patients who are not candidates for surgery
- •. Failure of medical treatments currently available for Cushing's disease (failure to normalize urinary free cortisol values after at least 3 months of treatment with the maximum tolerated dose of the drug and / or persistence of signs and symptoms related to hypercortisolism)
- •. Adequate contraception (see section 4.1.1)
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •- ACTH-independent Cushing's syndrome
- •- Pituitary surgery in the last 2 months prior to enrollment
- •- Radiotherapy in the previous 3 years
- •- Genetic-related causes of Cushing's syndrome (Carney complex, McCune-Albright syndrome, MEN-1)
- •- Major surgery in the month preceding the start of the study- Heart failure (NYHA class III or IV), unstable angina, severe arrhythmic syndrome, or clinically significant alteration of cardiovascular function
- •- Heart failure (NYHA class III or IV), unstable angina, severe arrhythmic syndrome, or clinically significant alteration of cardiovascular function
- •· Mitotane therapy in the year preceding the enrollment
- •- Hepatopathy, such as cirrhosis, chronic active hepatitis or chronic hepatitis, or AST / ALT levels> 2 x ULN, creatininemia> 2 x ULN, bilirubinemia> 2 x ULN
- •- White blood cell (WBCs) <3 x 109 / L; platelets <100 x 109 / L
- •- Any previous or current surgical or medical condition that may interfere with the conduct of the study or the evaluation of the results according to the Investigator's opinion
- •- Patients with ECG abnormalities or risk of torsades de pointes (correct QT> 470 mSec, hypokalemia, hypomagnesemia, family history of long QT syndrome)
- •- Pregnancy or lactation period
- •- Alcohol abuse or drug abuse
- •- Any other recent or active neoplastic disease (with the exception of cutaneous basal cancer and in situ carcinoma of the cervix or other malignant neoplasms without evidence of disease in the last 3 years)
- •- Acute infection or chronic uncontrolled infection
- •- Ongoing therapy with antifibrinolytic agents, such as tranexamic acid, aminocaproic acid or aprotinin
- •- Hypersensitivity to tretinoin or other retinoids, to cabergoline, ergot alkaloids, to soy, peanuts, fructose or to any of the excipients listed in section 6.1. of the RCP of the two IMPs
- •- History of pulmonary, pericardial or retroperitoneal fibrosis, evidence of cardiac valvulopathy determined on the echocardiogram performed before treatment
- •- Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •- Raynaud's syndrome
- •- History of peptic ulcer or previous gastrointestinal bleeding
- •- History of serious mental disorders (especially if psychotic)
- •- Patient judged to be potentially unreliable and/or uncooperative towards the procedures of the study or judged incapable of completing the entire study.
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