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    Summary
    EudraCT Number:2013-002133-37
    Sponsor's Protocol Code Number:COR-2012-01
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2013-002133-37
    A.3Full title of the trial
    An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease
    A.4.1Sponsor's protocol code numberCOR-2012-01
    A.5.4Other Identifiers
    Name:IND No.Number:115968
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCortendo AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCortendo AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCortendo AB
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Addressc/o TMF Sweden AB, Sergels Torg 12
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code111 57
    B.5.3.4CountrySweden
    B.5.6E-mailinfo@cortendo.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation number3/12/1012
    D.3 Description of the IMP
    D.3.1Product nameCOR-003
    D.3.2Product code COR-003
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 65277-42-I
    D.3.9.2Current sponsor codeCOR-003
    D.3.9.3Other descriptive name2S,4R-(-)-ketoconazole, levoketoconazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Endogenous Cushing's syndrome (CS) or Cushing's disease
    E.1.1.1Medical condition in easily understood language
    In this condition patients produce an excessive level of a steroid hormone known as cortisol
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10011657
    E.1.2Term Cushings syndrome
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical responder rate defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of hypercortisolism.
    E.2.2Secondary objectives of the trial
    • To identify the proportion of subjects with clinical response, defined as reduction in mean 24-hour UFC levels to below or equal to the upper limit of normal (≤ ULN) after each month of treatment with COR-003 without a dose increase during the Maintenance Phase;
    • To identify the proportion of subjects with complete or partial
    response, defined as ≥50% reduction of 24-hour UFC levels from
    Baseline after each of the 6 months of treatment with COR-003 without a dose increase during the Maintenance Phase;
    • To characterize changes in 24-hour UFC levels from Baseline during
    the 6 months of treatment with COR-003 in the Maintenance Phase
    regardless of dose increases;
    • To characterize shifts in normality for 24-hour UFC levels from
    Baseline during the 6 months of treatment with COR-003 in the
    Maintenance Phase regardless of dose increases;
    For all other secondary objectives, please refer to the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥18 years of age
    2. Able to provide written informed consent prior to any study
    procedures being performed; eligible subjects must be able to
    understand the informed consent form prior to inclusion into the study.
    3. Confirmed diagnosis of newly diagnosed, persistent or recurrent CD or endogenous CS of other etiology if subjects are not candidates for surgery or radiotherapy within the 18 months after enrollment.
    Previous medical records will be collected and used to support the
    diagnosis of CD or endogenous CS of other etiology, including the
    following etiologies:
    • Ectopic ACTH secretion, i.e. ACTH not of pituitary origin
    • Ectopic corticotropin-releasing hormone (CRH) secretion
    • Adrenal-dependent CS (i.e. adrenal adenoma (NOT carcinoma), adrenal hyperplasia, etc.)
    • Etiology unknown
    In the absence of pathological or post-surgical confirmation of the
    diagnosis of CD (i.e. documented adrenal insufficiency postadenomectomy or hypophysectomy, which will be considered
    diagnostic). The following historical evidence will be considered
    satisfactory to establish the diagnosis of CD:
    • Plasma corticotropin (ACTH) level >20 pg/mL (4.5 pmol/L) or greater (Note: ACTH ≥5 pg/mL (1.1 pmol/L) and ≤20 pg/mL will generally suffice only if accompanied by either a positive CRH stimulation test or DST or combined CRH-DST) PLUS one of the diagnostic strategies described below based on pituitary MRI/computed tomography (CT) findings (Note: pituitary imaging preceding the original diagnosis is a requirement for eligibility):
    • For tumors ≥6 mm by imaging:
    − Inferior petrosal sinus sampled (IPSS) ACTH central:plasma gradient
    ≥2 before CRH or ≥3 after CRH, OR if IPSS was not done then:
    − Positive ACTH and/or cortisol response to CRH/desmopressin or
    combined CRH-desmopressin stimulation plus high-dose (8 mg)
    dexamethasone suppression of plasma cortisol, ideally on more than one occasion, performed and interpreted according to internationally
    recognized standards of diagnosis
    − In the absence of IPPS and the combination of tests described, an
    individual might be eligible if CD was otherwise confirmed via adequate testing. Such cases must be discussed with and explicitly approved by the Medical Monitor, and the specific diagnostic criteria used to establish the diagnosis of CD must be documented.
    • For tumors <6 mm or not visible by MRI:
    − IPSS with ACTH central:plasma gradient ≥2 before CRH or ≥3 after
    CRH
    − In the absence of IPSS, an individual might be eligible if CD was
    otherwise confirmed via adequate testing. Such cases must be discussed with and explicitly approved by the Medical Monitor, and the specific diagnostic criteria used to establish the diagnosis of CD must be documented.
    4. Regardless of the etiology of endogenous CS, subjects MUST have
    elevated mean 24-hour UFC levels ≥1.5X ULN based on the normative range of the central lab assay and on a minimum of four measurements from adequately collected urine. Urine will ideally be collected on sequential days.
    5. In addition to elevated mean UFC, presence of abnormal values from one of the following tests:
    • Abnormal DST: Elevated 8 AM serum cortisol ≥1.8 μg/dL (50 nmol/L) after 1 mg dexamethasone orally at 11 PM the evening prior (if not conducted already in the diagnostic workup of the subject within the previous 2 months before start of Screening Phase; in that case previous test results and details of conduct will need to be available by the Baseline Visit)
    • Elevated late night salivary cortisol concentrations (at least two
    measurements) >ULN
    NOTE: For subjects with estimated glomerular filtration rate (eGFR as
    determined by Modified Diet in Renal Disease MDRD equation) >40 and <60 mL/min/1.73 m2 in addition to meeting the UFC criteria, late night salivary cortisol test results (≥2 measurements) MUST also demonstrate evidence of CS.
    6. Previously irradiated subjects with CD or endogenous CS of other
    etiology will be allowed as long as the radiation treatment occurred >4 years ago and subjects have not exhibited evidence for improvement in their underlying CD for 6 months prior to the Screening visit. The total number of previously irradiated subjects enrolled in this study will not exceed 10.
    7. Subjects with CD or CS of other etiology who are not candidates for surgery, refuse surgery, or in whom surgery will be delayed for at least 18 months following enrollment. Subjects may be allowed to participate in the trial while awaiting surgery, but must agree to complete this study prior to surgery. For subjects who have already
    undergone surgery, a minimum of 6 weeks should have elapsed before the subject can be deemed a surgical failure. Subjects who have undergone surgery should be stable post-surgery (i.e., no significant post-operative sequelae remain and the risk of such sequelae is considered negligible).
    For all other inclusion criteria, please refer to the protocol.
    E.4Principal exclusion criteria
    1. Subjects with Pseudo-CS based on assessment of the Investigator
    2. Subjects with cyclic CS based on assessment of the investigator
    3. Subjects with a non-endogenous source of hypercortisolism such as exogenous source of glucocorticoids or therapeutic use of ACTH.
    4. Known inherited syndrome as the cause of hypercortisolism, including but not limited to multiple endocrine neoplasia Type 1, McCune Albright Syndrome and Carney Complex
    5. Subjects with adrenal carcinoma
    6. History of malignancy, other than thyroid, early stage prostate,
    squamous cell and basal cell carcinoma, within 3 years prior to the
    Screening Phase. Subjects with history of such allowed carcinoma must have a life expectancy of >18 months and must be considered medically stable. Subjects with early stage prostate cancer undergoing no treatment due to low grade potential may be enrolled
    7. Clinical or radiological signs of compression of the optic chiasm
    8. Major surgery within 1 month prior to enrollment
    9. Subjects with clinically significant abnormality in 12-lead ECGs during the Screening Phase needing medical intervention
    10. Subjects with QTc interval of >470 msec during the Screening Phase
    11. Subjects with a history of Torsades des Pointes, or ventricular
    tachycardia, or ventricular fibrillation, or history of prolonged QT
    syndrome (including family history), or use of medications resulting in QT/QTc prolongation, or hypokalemia <3.0 meq/L.
    12.Pre-existing hepatic disease; subjects with mild to moderate hepatic steatosis consistent with fatty infiltration (non-alcoholic fatty liver disease [NAFLD] are allowed)
    13. Positive for HbsAg or positive HBC test.
    14. History or symptoms of recurrent symptomatic cholelithiasis or
    pancreatitis
    15. LFT must not be above the following cut-offs during the Screening
    Phase:
    • ALT and/or AST >3 X ULN
    • Total bilirubin (TBN) >2 X ULN
    If all LFTs are within normal limits and TBN is elevated, examination of direct and indirect bilirubin may be conducted. Subjects with isolated indirect TBN up to 3X ULN are presumed to have Gilbert's syndrome and may be enrolled if all other LFTs are within normal levels
    16. History of documented or suspected drug-induced liver injury
    requiring drug discontinuation of ketoconazole or any azole antifungals
    17. Pregnant or lactating women
    18. HIV positive
    19. History of persistent uncontrolled hypertension (>180/120 mmHg) despite medical intervention.
    20. Subjects with hypercholesterolemia currently treated with
    atorvastatin, lovastatin or simvastatin and not willing or unable to
    change to alternative therapies i.e. pravastatin, fluvastatin, or
    rosuvastatin within 2 weeks of start of the Screening Phase.
    21. Body habitus preventing repeated venipuncture as required by
    protocol.
    22. Subject is currently in another study or has received any
    investigational treatment (drug, biological agent or device) within 30
    days or five half-lives of treatment, whichever is longer.
    23. Repeated hospitalization for hyperglycemia or for any complication of hyperglycemia and diabetes during the last 12 months
    24. Subjects with decreased renal function as defined by eGFR <40
    mL/min/1.73 m2, using MDRD equation.
    25. Any other clinically significant medical condition, as determined by the Investigator that precludes enrollment and participation in the study through completion, including conditions that would preclude the subject from being able to follow instructions or to perform the necessary procedures
    26. Abnormal FT4. Subjects with TSH below the lower limit of normal
    (<LLN) and normal free T4 are permitted to participate in the study.
    27. Subjects who have a history of alcohol or drug abuse in the 6 month period prior to enrollment.
    28. Subjects who have been treated with mitotane within 6 months of the Screening Phase.
    29. Subjects who are currently taking any H2 receptor antagonists,
    proton-pump inhibitors, or sucralfate (all of which inhibit absorption of COR-003). A list of orally acceptable antacids (for example, Mylanta and Maalox) will be provided, and can only be taken a minimum of 2 hours after dosing of COR-003.
    30. Subjects who receive any prohibited concomitant medication and
    cannot discontinue it safely prior to the Baseline Visit:
    • Weight loss medications (prescription or over the counter)
    • Acetaminophen (paracetamol) >3 g total daily dose
    • Strong inducers or inhibitors of CYP3A4 enzyme system that may
    interfere with the metabolism of COR-003 and cannot be discontinued prior to first dose
    • Herbal Preparations: St John's Wort, echinacea, gingko, goldenseal,
    yohimbe, red rice yeast, danshen, silybum marianum, Asian ginseng,
    schissandra sphenanther, shankhapushi, and Asian herb mixture (Xiao chai hu tangand Salboku-to).
    • Topical or inhaled corticosteroids
    • Carbamazepine, fenofibrate, carbenoxolone.
    • Drugs that might pose unacceptable risks due to overlapping toxicities (eg. QT prolongation, liver toxicity);
    • Genuine licorice
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with response to COR-003, defined as reduction in mean 24-hour UFC levels to below or equal to the upper limit of normal (≤ ULN) following 6 months of Maintenance Phase therapy without a dose increase during that phase, summarized by Maintenance Phase dose level and overall.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following 6 months of maintenance phase therapy
    E.5.2Secondary end point(s)
    • Proportion of subjects with clinical response to COR-003, defined as mean UFC level ≤ ULN, to be determined after 1, 2, 3, 4 and 5 months of dosing without a dose increase in the Maintenance Phase;
    • Proportion of subjects with complete or partial response to COR-003, defined as mean UFC level ≥ 50% reduction from Baseline after 1, 2, 3, 4, 5 and 6 months of dosing without a dose increase in the Maintenance Phase;
    • Change and percentage change from Baseline in mean 24-hour UFC
    levels after 1, 2, 3, 4, 5 and 6 months of dosing in the Maintenance
    Phase regardless of dose increases;
    • Shift in UFC normality categories from Baseline to 1, 2, 3, 4, 5 and 6
    months of dosing in the Maintenance Phase regardless of dose increases;
    • Change and percentage change from Baseline in serum and late night salivary cortisol levels after 1, 2, 3, 4, 5 and 6 months of dosing in the Maintenance Phase;
    • Changes from Baseline in Clinical Signs and Symptoms of CS after 1, 2, 3, 4, 5 and 6 months of dosing in the Maintenance Phase;
    • Changes from Baseline in the QoL measures obtained from the Cushing QoL questionnaire and the severity of depression obtained from the Beck's Depression Inventory II after 3 and 6 months of dosing in the Maintenance Phase;
    • Change from Baseline in CS comorbidities biomarkers (fasting glucose, hemoglobin A1C [HbA1c], systolic blood pressure [SBP], diastolic blood pressure [DBP], total cholesterol, low and high density lipoproteins [LDL, HDL, respectively], and body weight) after 1, 2, 3, 4, 5 and 6 months of dosing in the Maintenance Phase;
    • Changes from Baseline for oral glucose tolerance test (OGTT) (prediabetics only) and spot albumin/creatinine ratio as a measure of
    microalbuminuria (only if abnormal at Baseline) after 3 and 6 months of dosing in the Maintenance Phase;
    • Changes from Baseline for C-reactive protein (CRP) after 1, 2, 3, 4, 5
    and 6 months of dosing in the Maintenance Phase;
    • Safety evaluations will include clinical observations and adverse event (AE) reporting, vital signs (SBP, DBP, body weight, body mass index [BMI]), electrocardiograms (ECGs), hematology, chemistry panels (inclusive of expanded markers of liver function, ACTH, Insulin-like Growth Factor-1 (IGF-1) and testosterone concentrations), dipstick urinalysis (microscopic evaluation, if dipstick positive), tumor size by magnetic resonance imaging (MRI) as applicable.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depending on criteria being measured. 1, 2, 3, 4, 5 & 6 months in maintenance phase. 9 and 12 months in extended evaluation phase.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    France
    Georgia
    Germany
    Hungary
    Israel
    Italy
    Netherlands
    Poland
    Romania
    Serbia
    Spain
    Sweden
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 90
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the end of the study COR-003 may be provided under an extension study protocol for subjects who wish to continue treatment, who benefit from the treatment and for who the benefits outweigh the risks.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-20
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