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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome

NCTNCT01371565 (opens ClinicalTrials.gov in a new tab)Other idC1073-405
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures ACTH (corticotropin), does not give it. It appears in the eligibility rules.

Overview

Status
Completed
Phase
Phase 3
Enrollment
4 participants (actual)
Sponsor
Corcept Therapeutics · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Nov 2010
Primary completion
Jun 2012
Completion
Sept 2012
First posted
13 Jun 2011 (estimated)
Last update posted
18 Mar 2014 (estimated)
Conditions
Cushing's Disease · Cushing's Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph 3

    Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome

    NCT01371565

    Nov 2010 to Sept 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a compassionate use study. In addition to providing compassionate use access to mifepristone, objectives of the study will be to evaluate the safety and utility of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome when given on a compassionate use basis. The study will only enroll subjects whose physicians have determined that medical treatment is needed to control the symptoms or signs of hypercortisolemia.

Interventions

  • MifepristoneDrug

Arms1

  • Experimental

    mifepristone

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Adverse Events

    Time frame · 6 months

    Registry description

    Safety was assessed at all visits and adverse events were recorded.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 6 months

Number of Participants With Adverse Events

GroupValue (participants)
Mifepristone4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
MifepristoneAt doses from 300mg/day up to 1200mg/day–1 / 44 / 4

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or ACTH independent etiologies including: * Cushing's Disease that (more than one may apply) * has recurred after primary pituitary surgery * has persisted despite pituitary surgery (failed pituitary surgery) * has been treated with radiation therapy to the pituitary * is not treatable with surgery * exists in subjects who are not candidates for or who refuse surgery * Ectopic ACTH * Ectopic CRF secretion * Adrenal adenoma * Adrenal carcinoma * Adrenal autonomy 2. Have documented biochemical evidence of endogenous hypercortisolemia which includes elevated urinary free cortisol. 3. Require medical treatment of hypercortisolemia. Exclusion Criteria: Individuals not eligible to be enrolled into the study are those who: * Have de novo Cushing's disease and are surgical candidates for pituitary surgery. * Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment. * Taking medications within 14 days of the baseline visit (Day 1) that a) have a large first pass metabolism largely mediated by CYP3A4 and a narrow therapeutic margin and/or b) are strong CYP3A4 inhibitors. * Female patients of reproductive potential, who are pregnant or who are unable or unwilling to use medically acceptable, non-hormonal methods of contraception during the study. * Have received investigational treatment (drug, biological agent or device) within 30 days of Screening * Have a history of an allergic reaction or intolerance to CORLUX (mifepristone) * Have a non-endogenous source of hypercortisolemia such as factious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factious or therapeutic use of ACTH * Have Pseudo-Cushing's syndrome. * Postmenopausal women with an intact uterus who have experienced unexplained vaginal bleeding within 12 months of Screening are excluded.

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