Cushing's SyndromePhase 3NCT00936741
An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome
A Phase 3 study testing mifepristone in people with Cushing's Syndrome, run by Corcept Therapeutics at 15 sites in United States.
Trial summary
Participants in study C-1073-400 (NCT00569582) will be invited to participate in this extension study to examine the long term safety of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing's Syndrome
- What is being tested?
- mifepristone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 15 sitesUnited States
- Study dates
- Jul 2009to 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 completed the Week 24 visit and the 6-Week Follow-up visit of Corcept Study C-1073-400 (NCT00569582).
- In the opinion of the Investigator, are expected to maintain clinical benefit from mifepristone.
- Women of childbearing potential have a negative serum pregnancy test at Entry.
- Women of childbearing potential must be willing to use non-hormonal, medically acceptable methods of contraception during the study.
- Are able to provide written informed consent
- Are able to return to the investigative site to complete the study evaluations outlined in the protocol.
- Will not use systemic estrogens during the study.
Who cannot join
- Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment.
- Are taking medications within 14 days of the Entry visit that a) have a large first pass metabolism that is largely mediated by CYP3A4 and which have 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) other than CORLUX (mifepristone) within 30 days of Entry
- Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
- Have uncorrected hypokalemia (potassium level of <3.5 mEq/L) at Entry. Spironolactone or eplerenone is allowed to control hypokalemia.
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- Postmenopausal women with a history of endometrial hyperplasia with atypia or pathological features consistent with endometrial carcinoma.
- Thickened endometrium on the Entry Visit transvaginal ultrasound that has not resolved after induction of menstrual bleeding with progesterone.
- Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- Any woman with an intact uterus who has a hemorrhagic disorder or is being treated with an anticoagulant (e.g. warfarin, heparin).
- Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.
- Elevated total bilirubin >1.5 ULN, elevated ALT or AST ≥3X the upper limit of normal.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University Feinberg Medical; Division of Endocrinology, Metabolism & Molecular Medicine
Chicago, Illinois, 60611
Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8857
AMCR Institute Inc.
Escondido, California, 92026
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Endocrinology Center at Community Medical Commons
Menomonee Falls, Wisconsin, 53051
Oklahoma Diabetes Center
Oklahoma City, Oklahoma, 73104
Oregon Health Sciences University
Portland, Oregon, 97239
Stanford University Medical Center
Stanford, California, 94305-5826
About this study
Official title: An Open Label Extension Study of the Efficacy and Safety of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome
Participants in study C-1073-400 (NCT00569582) will be invited to participate in this extension study to examine the long term safety of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome. Total treatment duration may be up to 12 months or longer at the discretion of the Investigator.
Read the detailed description
Up to 50 subjects will receive mifepristone daily. Subjects completing 24 weeks of mifepristone treatment under Corcept protocol C1073-400 (NCT00569582) will be eligible to continue treatment for an additional 1 year. Assessments of safety, as evaluated by physical examinations, vital signs, laboratory tests and adverse events, will be made. Persistence of improvement in response to mifepristone treatment will also be evaluated during this extension study by assessing the continued or sustained improvement in the signs and symptoms of Cushing's syndrome.
- Conditions
- Cushing's Syndrome
- Being tested
- mifepristone
- Keywords
- Cushing's Disease, Cushing's Syndrome, Cushings, Pituitary, ACTH, Adrenocorticotropic hormone, Ectopic, Adrenal adenoma, Adrenal carcinoma, Adrenal autonomy, Cortisol, Hypercortisolemia, Cushingoid, Moon facies, Dorsocervical fat, Plethora, Hirsutism, Violaceous striae, Hormone, Contraceptive
- Medical subject headings
- Cushing Syndrome, Pituitary ACTH Hypersecretion, Pituitary Diseases, Choristoma, ACTH Syndrome, Ectopic, Adrenal Cortex Neoplasms, Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mifepristoneDrug
Also called CORLUX
Mifepristone 300 mg to 1200 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone | Experimental | Mifepristone 300mg to 1200mg once daily 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
Subjects who received at least one dose of mifepristone were included in the safety analysis.
Measured: Up to three years.
Secondary outcomes (1)
The Long-term Benefit of Mifepristone Treatment in Cushing's Syndrome as Measured by Changes in the Score on the Physician's Global Assessment of Disease Severity
The mean Investigator's rating of the change in subject's signs and symptoms of Cushing's syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician's Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here.
The instruction was "Rate the change in the subject's signs and symptoms of Cushing's from Baseline (1 = much better to 9 = much worse)".
Measured: Up to three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionSep 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cushing's SyndromeStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Coleman Gross, MD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936741
- Sponsor's protocol ID
- C-1073-415
- Status last verified
- Feb 2014
- First submitted
- 9 Jul 2009
- Last updated
- 2 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fein HG, Vaughan TB 3rd, Kushner H, Cram D, Nguyen D. Sustained weight loss in patients treated with mifepristone for Cushing's syndrome: a follow-up analysis of the SEISMIC study and long-term extension. BMC Endocr Disord. 2015 Oct 27;15:63. doi: 10.1186/s12902-015-0059-5.
PubMed 26507877Fleseriu M, Findling JW, Koch CA, Schlaffer SM, Buchfelder M, Gross C. Changes in plasma ACTH levels and corticotroph tumor size in patients with Cushing's disease during long-term treatment with the glucocorticoid receptor antagonist mifepristone. J Clin Endocrinol Metab. 2014 Oct;99(10):3718-27. doi: 10.1210/jc.2014-1843. Epub 2014 Jul 11.
PubMed 25013998
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Extension Study of the Efficacy and Safety of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome
- ClinicalTrials.gov ID
- NCT00936741
- Acronym / sponsor ID
- C-1073-415
- Conditions
- Cushing's Syndrome
- Keywords
- Cushing's Disease, Cushing's Syndrome, Cushings, Pituitary, ACTH, Adrenocorticotropic hormone, Ectopic, Adrenal adenoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Posted 2 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants in study C-1073-400 (NCT00569582) will be invited to participate in this extension study to examine the long term safety of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome. Total treatment duration may be up to 12 months or longer at the discretion of the Investigator.
Detailed description
Up to 50 subjects will receive mifepristone daily. Subjects completing 24 weeks of mifepristone treatment under Corcept protocol C1073-400 (NCT00569582) will be eligible to continue treatment for an additional 1 year. Assessments of safety, as evaluated by physical examinations, vital signs, laboratory tests and adverse events, will be made. Persistence of improvement in response to mifepristone treatment will also be evaluated during this extension study by assessing the continued or sustained improvement in the signs and symptoms of Cushing's syndrome.
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: mifepristoneMifepristone 300mg to 1200mg once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have completed the Week 24 visit and the 6-Week Follow-up visit of Corcept Study C-1073-400 (NCT00569582).
- In the opinion of the Investigator, are expected to maintain clinical benefit from mifepristone.
- Women of childbearing potential have a negative serum pregnancy test at Entry.
- Women of childbearing potential must be willing to use non-hormonal, medically acceptable methods of contraception during the study.
- Are able to provide written informed consent
Key exclusion criteria (12 listed)
- Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment.
- Are taking medications within 14 days of the Entry visit that a) have a large first pass metabolism that is largely mediated by CYP3A4 and which have 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) other than CORLUX (mifepristone) within 30 days of Entry
- Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
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: CORLUXMifepristone 300 mg to 1200 mg once daily | Drug | Mifepristone |
Primary outcome
Number of Participants With Adverse Events
Time frame: Up to three years.
Subjects who received at least one dose of mifepristone were included in the safety analysis.
1 secondary outcome
The Long-term Benefit of Mifepristone Treatment in Cushing's Syndrome as Measured by Changes in the Score on the Physician's Global Assessment of Disease Severity
Time frame: Up to three years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26507877Fein HG, Vaughan TB 3rd, Kushner H, Cram D, Nguyen D. Sustained weight loss in patients treated with mifepristone for Cushing's syndrome: a follow-up analysis of the SEISMIC study and long-term extension. BMC Endocr Disord. 2015 Oct 27;15:63. doi: 10.1186/s12902-015-0059-5.
- Derived from this study: PubMed 25013998Fleseriu M, Findling JW, Koch CA, Schlaffer SM, Buchfelder M, Gross C. Changes in plasma ACTH levels and corticotroph tumor size in patients with Cushing's disease during long-term treatment with the glucocorticoid receptor antagonist mifepristone. J Clin Endocrinol Metab. 2014 Oct;99(10):3718-27. doi: 10.1210/jc.2014-1843. Epub 2014 Jul 11.
- Corcept C-1073-400 Clinicaltrials.gov Study ListingLink provided by the sponsor.
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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, MD study director
Corcept Therapeutics
15 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 Syndrome, run by Corcept Therapeutics at 15 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 7 inclusion and 12 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 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 2 Apr 2014). 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: Up to three years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00936741, which also lists 2 linked publications.
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 2 Apr 2014.