Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. MedDRA version: 8.1 Level: LLT Classification code 10014155 Term: Ectopic corticotrophin syndrome
Conditions
Interventions
Product Code: HRA052015
Pharmaceutical Form: Tablet
INN or Proposed INN: mifepristone
CAS Number: 84371-65-3
Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-d
Sponsors
Laboratoire HRA Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
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: o Diabetes defined by ? fasting plasma glucose level = 7.0 mmol/l (126 mg/dl) ? or 2-hour glucose plasma level after 75 g OGTT = 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 = 7.8 mmol/l (140 mg/dl) ) and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 5 µg/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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate that daily administration of mifepristone in subjects with Cushing's syndrome caused by ectopic ACTH secretion will improve the glucocorticoid-dependent parameters of blood pressure and/or glucose tolerance.;Secondary Objective: The secondary objectives of this study are to assess the impact of long-term administration of mifepristone on other glucocorticoid-dependent parameters, and the safety of the agent. The clinical and biochemical features and safety parameters which will be evaluated are detailed in protocol.;Primary end point(s): Assessment of primary efficacy data will be based on: Blood pressure (supine blood pressure) and glucose tolerance (fasting glucose in diabetes and 2-hour OGTT in glucose intolerance) measured at visit P and additional visits M1 to M3 as applicable. | — |
Countries
France, Germany, Italy, Netherlands
Outcome results
None listed