Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing s syndrome caused by ectopic Adrenal Corticotrophin Hormone ACTH secretion - HRA052015 in EAS

• Conditions: Cushing s Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone ACTH Secretion; MedDRA version: 9.1Level: LLTClassification code 10014146Term: Ectopic ACTH syndrome

• Registration Number: EUCTR2006-004679-36-IT
• Lead Sponsor: ABORATOIRE HRA PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-30
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Subjects will be included if they have ALL of the three following criteria 1. Hypercortisolism from Cushing s syndrome caused by ectopic ACTH secretion confirmed by - Inferior petrosal sinus sampling IPSS with a central to peripheral ACTH ratio of less than 2.0 before CRH administration and less than 3.0 after CRH administration. - or biopsy with ACTH immunoreactivity. - or presence of a tumor evidenced by imaging combined with both a negative CRH test and a negative 8 mg dexamethasone suppression test. No major change in tumor status/anti-tumor therapy should be expected during the study AND 2. Glucose intolerance AND/OR hypertension that is considered to be caused or worsened by the hypercortisolism - Diabetes defined by fasting plasma glucose level greater than or equal to 7.0 mmol/l 126 mg/dl or 2-hour glucose plasma level after 75 g OGTT greater than or equal to 11.1 mmol/l 200 mg/dl or treated diabetes or glucose intolerance defined by fasting plasma glucose values between 5.5 mmol/l 100 mg/dl and 7.0 mmol/l 126 mg/dl or 2-hour glucose plasma level after 75 g OGTT greater than or equal to 7.8 mmol/l 140 mg/dl and 11.1 mmol/l 200 mg/dl Prior to study entry, fasting blood sugar must be less than 11.1 mmol/l 200 mg/dl for at least two weeks - Hypertension defined by systolic BP greater than or equal to 140 mm Hg and/or diastolic BP greater than or equal to 90 mm Hg Prior to study entry, BP must be less than 180/110 mmHg for at least two weeks or treated hypertension AND 3. At least one of the following symptoms attributable to the Cushing s syndrome - Body weight increase or truncal obesity - Depression or treated depression or psychiatric disorder - Fatigue - Proximal muscle weakness - Hirsutism - Hypokalemia - Bruising - Violaceous striae - In men, gynecomastia or libido decrease - Impaired cognition or memory - Hyperpigmentation - Amenorrhea - Osteopenia or osteoporosis In addition, the following criteria should be met - Written informed consent to participate in the study - Female subjects should be sterilized, post-menopausal, sexually inactive or willing to use barrier methods of contraception throughout the study. - Subject willing to return to investigational site during the full course of the study - Age in the range of 18 to 75 years inclusive
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Evidence for Cushing s disease as judged by positive inferior petrosal sinus sampling or a lesion on pituitary MRI with positive CRH test - Suspected or known adrenocortical cancer or adenomas, as judged by ACTH values 10 pg/ml and adrenal mass - Subjects with cyclic Cushing s syndrome defined by at least 3 measurements of Urinary Free Cortisol over the previous two months without normal values. - Children age less than 18 and subject of more than 75 years of age - Pregnant or lactating women. A urinary pregnancy test will be performed in women of childbearing potential unless they have a history of menopause prior to Cushing s syndrome or hysterectomy - Life expectancy less than three months - Severe uncontrolled diabetes - Grade III or IV hypertension - Recent less than two weeks prior to inclusion initiation of corrective treatments for diabetes, hypertension or depression - Clinically significantly impaired cardiovascular function e.g. stage IV cardiac failure - Severe liver disease liver enzymes greater than or equal to 3 x the institutional upper limit of normal range - Severe renal impairment serum creatinine greater than or equal to 2.2 mg/dl or creatinine clearance 30 ml/min - Uncontrolled severe active infection - In women, known endometrial cancer, history of endometrial hyperplasia or vaginal bleeding of unknown cause - Recent less than two weeks prior to inclusion initiation of or significant change in dose of anti-tumor therapy - Treatment with approved or experimental steroidogenesis inhibitors, adrenolytic agents or somatostatin analogues within four weeks of admission - Plasma mitotane concentration 5 g/ml - Impaired mental capacity or markedly abnormal psychiatric evaluation that precludes informed consent - Body weight over 136 kg, which is the limit for the tables used in the scanning areas

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified