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Status:

TERMINATED

Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion

Lead Sponsor:

HRA Pharma

Conditions:

Cushing's Syndrome

Eligibility:

All Genders

18-85 years

Phase:

PHASE2

Brief Summary

This study will evaluate whether the drug mifepristone can improve the symptoms of Cushing's syndrome in people with ectopic adrenal corticotrophin hormone (ACTH) secretion. Cushing's syndrome occurs ...

Detailed Description

Between 10% and 20% of patients with hypercortisolism (Cushing's Syndrome) have tumoral ectopic production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. If an ectopic tumor cannot...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Subjects will be included if they have ALL of the three following criteria:
  • Hypercortisolism from Cushing's syndrome caused by ACTH ectopic secretion
  • AND
  • Glycemic disorder that is considered to be caused or worsened by the hypercortisolism
  • AND
  • At least one symptom attributable to the Cushing's syndrome.
  • 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 less than 10 pg/ml and adrenal mass
  • Subjects with cyclic Cushing's syndrome defined by any measurement of Urinary Free Cortisol over the previous 2 months less than 2 N
  • Children (age less than 18) and patients over 85 years
  • 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 two months
  • Surgery planned within 8 weeks after inclusion, especially bilateral adrenalectomy
  • Uncontrolled diabetes (plasma glucose greater than 15.0 mmol/L (270 mg/L) and/or HbA1c greater than 10%)
  • Uncontrolled hypertension (blood pressure greater than 180/110 mmHg)
  • Recent (less than two weeks prior to inclusion) initiation of corrective treatments for 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 less than 30 ml/min)
  • Severe hypokalemia (plasma K below 3.0 mmol/L)
  • Uncontrolled severe active infection
  • In women, known endometrial cancer, history of endometrial hyperplasia or vaginal bleeding of unknown cause
  • Premenopausal women with hemorrhagic disorders or on anticoagulants
  • Recent (less than two weeks prior to inclusion) initiation of or significant change in dose of anti-tumor therapy
  • Previous treatment with approved or experimental steroidogenesis inhibitors, somatostatin analogues within one week of admission (eight weeks for patients on octreotide LAR or on lanreotide autogel)
  • Plasma mitotane concentration greater than 5 microgram/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
  • Inherited porphyria
  • Positive pregnancy test at inclusion
  • Use of antiretroviral agents, midazolam, cabergoline, erythromycin, or grapefruit juice within two weeks of the study

Exclusion

    Key Trial Info

    Start Date :

    May 15 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 4 2012

    Estimated Enrollment :

    18 Patients enrolled

    Trial Details

    Trial ID

    NCT00422201

    Start Date

    May 15 2007

    End Date

    April 4 2012

    Last Update

    October 11 2019

    Active Locations (15)

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    Page 1 of 4 (15 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892

    2

    CHU de Bordeaux Hopital Haut Leveque

    Bordeaux, France

    3

    C.H.U Albert Michallon

    Grenoble, France

    4

    C.H.U. de Bicetre

    Le Kremlin-Bicêtre, France