Cushing's DiseasePhase 3NCT01371565
Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome
A Phase 3 study testing Mifepristone in people with Cushing's Disease and Cushing's Syndrome, run by Corcept Therapeutics at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing's Disease, Cushing's Syndrome
- What is being tested?
- Mifepristone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2010to Sep 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- exists in subjects who are not candidates for or who refuse surgery
- Ectopic ACTH
- Ectopic CRF secretion
- Adrenal adenoma
- Adrenal carcinoma
- Adrenal autonomy
- Have documented biochemical evidence of endogenous hypercortisolemia which includes elevated urinary free cortisol.
- Require medical treatment of hypercortisolemia.
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University, Division of Endocrinology Diabetes and Metabolism
Columbus, Ohio, 43210
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021
About this study
Official title: Compassionate Use Protocol for the Administration of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome
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.
- Conditions
- Cushing's Disease, Cushing's Syndrome
- Being tested
- Mifepristone
- Keywords
- Cushing's Disease, Cushing's Syndrome, Cushings, Pituitary, Ectopic ACTH secretion
- Medical subject headings
- Pituitary ACTH Hypersecretion, Cushing Syndrome, Pituitary Diseases, ACTH Syndrome, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called CORLUX®
mifepristone at doses from 300mg/day up to 1200mg/day
| Study group | Role | What they receive |
|---|---|---|
| mifepristone | Experimental | Not described Receives: Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Safety was assessed at all visits and adverse events were recorded.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cushing's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Coleman Gross, M.D., Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371565
- Sponsor's protocol ID
- C1073-405
- Status last verified
- Feb 2014
- First submitted
- 7 Jun 2011
- Last updated
- 18 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use Protocol for the Administration of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome
- ClinicalTrials.gov ID
- NCT01371565
- Acronym / sponsor ID
- C1073-405
- Conditions
- Cushing's Disease, Cushing's Syndrome
- Keywords
- Cushing's Disease, Cushing's Syndrome, Cushings, Pituitary, Ectopic ACTH secretion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Posted 20 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mifepristone | Experimental | Drug: Mifepristone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or ACTH independent etiologies including:
- Have documented biochemical evidence of endogenous hypercortisolemia which includes elevated urinary free cortisol.
- Require medical treatment of hypercortisolemia.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MifepristoneAlso: CORLUX®mifepristone at doses from 300mg/day up to 1200mg/day | Drug | mifepristone |
Primary outcome
Number of Participants With Adverse Events
Time frame: 6 months
Safety was assessed at all visits and adverse events were recorded.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Coleman Gross, M.D. study director
Corcept Therapeutics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mifepristone in people with Cushing's Disease and Cushing's Syndrome, run by Corcept Therapeutics at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.