Archive History for NCT00936741
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`Page 1 of 7
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`History of Changes for Study: NCT00936741
`
`An Extension Study of CORLUX in the Treatment of Endogenous Cushing's
`Syndrome
`
`Latest version (February 19, 2014) on ClinicalTrials.gov
`
`• A study version is represented by a row in the table.
`• Select two study versions to compare. One each from columns A and B.
`• Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study
`versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the
`study.
`• Click "Compare" to do the comparison and show the differences.
`• Select a version's date link to see a rendering of the study for that version.
`• Edits or deletions will be displayed in red.
`• Additions will be displayed in green .
`• The yellow choices in the table indicate the study versions currently compared below. A yellow
`row indicates the study version being viewed.
`• Hover over the "Recruitment Status" to see how the study's recruitment status changed.
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`Study Record Versions
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`Version
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`A
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`B
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`Date
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`Changes
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`2
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`July 9, 2009 Nothing (earliest Version on record)
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`September 23, 2009 Study Status and Contacts/Locations
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`November 3, 2009 Study Status and Contacts/Locations
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`March 19, 2010 Study Status and Contacts/Locations
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`May 25, 2010
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`Study Status, Outcome Measures,
`Contacts/Locations and Study Description
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`July 7, 2010 Study Status and Contacts/Locations
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`https://clinicaltrials.gov/ct2/history/NCT00936741?V_1=View
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`12/4/2018
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`1
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`TEVA1028
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`Page 1 of 7
`
`History of Changes for Study: NCT00936741
`
`An Extension Study of CORLUX in the Treatment of Endogenous Cushing's
`Syndrome
`
`Latest version (February 19, 2014) on ClinicalTrials.gov
`
`• A study version is represented by a row in the table.
`• Select two study versions to compare. One each from columns A and B.
`• Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study
`versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the
`study.
`• Click "Compare" to do the comparison and show the differences.
`• Select a version's date link to see a rendering of the study for that version.
`• Edits or deletions will be displayed in red.
`• Additions will be displayed in green .
`• The yellow choices in the table indicate the study versions currently compared below. A yellow
`row indicates the study version being viewed.
`• Hover over the "Recruitment Status" to see how the study's recruitment status changed.
`
`Study Record Versions
`
`Version
`
`A
`
`B
`
`Date
`
`Changes
`
`1
`
`2
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`3
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`4
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`5
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`6
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`July 9, 2009 Nothing (earliest Version on record)
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`September 23, 2009 Study Status and Contacts/Locations
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`November 3, 2009 Study Status and Contacts/Locations
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`March 19, 2010 Study Status and Contacts/Locations
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`May 25, 2010
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`Study Status, Outcome Measures,
`Contacts/Locations and Study Description
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`July 7, 2010 Study Status and Contacts/Locations
`
`https://clinicaltrials.gov/ct2/history/NCT00936741?V_1=View
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`12/4/2018
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`TEVA1028
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`Archive History for NCT00936741
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`Page 2 of 7
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`A
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`B
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`Version
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`Changes
`Date
`July 16, 2010 Contacts/Locations and Study Status
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`9
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`10
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`June 22, 2011 Study Status
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`August 10, 2012
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`Recruitment Status, Sponsor/Collaborators and
`Study Status
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`February 19, 2014
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`Recruitment Status, Study Status, Outcome
`Measures, Arms and Interventions, Study
`Design, Study Description, Results, Eligibility
`and Conditions
`
`Compare
`
`Comparison Format:
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` Merged
` Side-by-Side
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`Scroll up to access the controls
`
`Study NCT00936741
`on Date: July 9, 2009 (v1)
`
`Study Identification
`Unique Protocol ID: C-1073-415
`
`Brief Title: An Extension Study of CORLUX in the Treatment of
`Endogenous Cushing's Syndrome
`
`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
`
`Secondary IDs:
`
`Study Status
`
`Record Verification: July 2009
`
`Overall Status: Unknown status [Previously:
`Enrolling by invitation]
`
`Study Start: July 2009
`
`Primary Completion: August 2011 [Anticipated]
`
`Study Completion: August 2011 [Anticipated]
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`https://clinicaltrials.gov/ct2/history/NCT00936741?V_1=View
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`Archive History for NCT00936741
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`Page 3 of 7
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`First Submitted: July 9, 2009
`
`First Submitted that
`Met QC Criteria:
`
`July 9, 2009
`
`First Posted: July 10, 2009 [Estimate]
`
`Last Update Submitted that
`Met QC Criteria:
`
`July 9, 2009
`
`Last Update Posted: July 10, 2009 [Estimate]
`
`Sponsor/Collaborators
`
`Sponsor: Corcept Therapeutics
`
`Responsible Party:
`
`Collaborators:
`
`Oversight
`U.S. FDA-regulated Drug:
`
`U.S. FDA-regulated Device:
`
`Data Monitoring: No
`
`Study Description
`Brief Summary: Participants in study C-1073-400 (SEISMIC) 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.
`
`Detailed Description: Up to 50 subjects will receive mifepristone daily. Subjects
`completing 24 weeks of mifepristone treatment under
`Corcept protocol C1073-400 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
`
`Conditions: Cushing's Syndrome
`
`https://clinicaltrials.gov/ct2/history/NCT00936741?V_1=View
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`Archive History for NCT00936741
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`Page 4 of 7
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`Keywords: Cushing's Disease
`Cushing's Syndrome
`Cushings
`Pituitary
`ACTH
`Adrenocorticotropic hormone
`Ectopic
`Adrenal adenoma
`Adrenal carcinoma
`Adrenal autonomy
`Cortisol
`Hypercortisolemia
`Cushinoid
`Moon facies
`Dorsalcervical fat
`Plethora
`Hirsutism
`Violaceous striae
`Hormone
`Contraceptive
`Endocrine
`Cushing Syndrome
`Ectopic ACTH Secretion
`
`Study Design
`
`Study Type: Interventional
`
`Primary Purpose: Treatment
`
`Study Phase: Phase 3
`
`Interventional Study Model: Single Group Assignment
`
`Number of Arms: 1
`
`Masking: None (Open Label)
`
`Allocation: N/A
`
`Enrollment: 50 [Anticipated]
`
`Arms and Interventions
`Arms
`Experimental: Open-label
`mifepristone
`
`Assigned Interventions
`Drug: mifepristone
`
`https://clinicaltrials.gov/ct2/history/NCT00936741?V_1=View
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`Archive History for NCT00936741
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`Arms
`
`Assigned Interventions
`mifepristone at doses from 300 mg/day
`up to 1200 mg/day daily
`
`Other Names:
`
`• CORLUX
`
`Outcome Measures
`Primary Outcome Measures:
`
`1. Long term safety of mifepristone treatment
`12 months
`
`Secondary Outcome Measures:
`
`2. Persistence of therapeutic benefit due to continued mifepristone treatment
`12 months
`
`Eligibility
`
`Minimum Age: 18 Years
`
`Maximum Age:
`
`Sex: All
`
`Gender Based:
`
`Accepts Healthy Volunteers: No
`
`Criteria: Inclusion Criteria:
`
`• Have completed the Week 24 visit and the 6-Week
`Follow-up visit of Corcept Study C-1073-400.
`• 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.
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`https://clinicaltrials.gov/ct2/history/NCT00936741?V_1=View
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`Archive History for NCT00936741
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`Page 6 of 7
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`• Will not use systemic estrogens during the study.
`
`Exclusion Criteria:
`
`• 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.
`• 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.
`
`https://clinicaltrials.gov/ct2/history/NCT00936741?V_1=View
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`Archive History for NCT00936741
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`Page 7 of 7
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`Contacts/Locations
`Study Officials: Coleman Gross, MD
`Study Director
`Corcept Therapeutics
`Locations: United States, Florida
`The Center for Diabetes and Endocrine Care
`Hollywood, Florida, United States, 33021
`United States, Illinois
`Northwestern University Feinberg Medical; Division of
`Endocrinology, Metabolism & Molecular Medicine
`Chicago, Illinois, United States, 60611
`
`IPDSharing
`
`References
`
`Plan to Share IPD:
`
`Citations: 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 26507877
`
`Fleseriu 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
`
`Links:
`
`Available IPD/Information:
`
`Scroll up to access the controls
`
`Scroll to the Study top
`
`U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human
`Services
`
`https://clinicaltrials.gov/ct2/history/NCT00936741?V_1=View
`
`12/4/2018
`
`7
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