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    Summary
    EudraCT Number:2009-010613-68
    Sponsor's Protocol Code Number:X-55-58064-004
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-17
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-010613-68
    A.3Full title of the trial
    A phase II international multicentre randomised open label study of oral steroid sulphatase inhibitor BN83495 versus megestrol acetate (MA) in women with advanced or recurrent endometrial cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The researchers think that BN83495 may be better than megace to treat women with womb cancer that is advanced or has come back after treatment. The aims of this trial are to find out how well BN83495 works for women with womb cancer that is advanced or has come back, how safe BN83495 is for these women and ow it affects their quality of life
    A.4.1Sponsor's protocol code numberX-55-58064-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00910091
    A.5.3WHO Universal Trial Reference Number (UTRN)U2009-0106-1368
    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 SponsorIpsen Pharma
    B.1.3.4CountryFrance
    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 supportIpsen Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Pharma
    B.5.2Functional name of contact pointVP Clinical Sciences
    B.5.3 Address:
    B.5.3.1Street Address65 quai Georges Gorse
    B.5.3.2Town/ cityBoulogne Billancourt CEDEX
    B.5.3.3Post code92650
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)158 33 50 00
    B.5.5Fax number+33(0)158 33 50 01
    B.5.6E-mailct-application@ipsen.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code BN83495
    D.3.4Pharmaceutical form 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.3.9.1CAS number 288628-05-7
    D.3.9.2Current sponsor codeBN83495
    D.3.9.3Other descriptive nameSTX64, 667-coumate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Megace
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Holdings Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNMegestrol Acetate
    D.3.9.1CAS number 595-33-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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
    Advanced or recurrent endometrial cancer
    E.1.1.1Medical condition in easily understood language
    Advanced or recurrent cancer of the endometrium (the lining of the uterus) which presents female hormonal receptors.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10014733
    E.1.2Term Endometrial cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the antitumour efficacy of BN83495 measured by percentage of women with advanced or recurrent endometrial cancer who have neither progressed nor died after 6 months of treatment.

    Response and progression will be evaluated by the investigator (local review) in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumours (RECIST) committee version 1.0.
    E.2.2Secondary objectives of the trial
    - Assess safety and tolerability of BN83495
    - Assess the following parameters of antitumour efficacy:
    - Progression Free Survival (PFS): time from randomisation until objective tumour progression or death from any cause
    - Clinical Benefit
    - Overall Response
    - Time to Progression
    - Duration of Response
    - Overall Survival at 2 years.
    The following will be assessed up to the cut-off date of 17 January 2012:
    - Quality of life using EuroQoL EQ-5D
    - Effect of treatment on age-related frailty using an oncogeriatric assessment in patients > 65 years
    - Pharmacodynamic effects of BN83495 on plasma steriod hormone levels in post-menopausal women
    - Pharmacokinetic profile of BN83495 in this patient population after repeated daily administration by means of a population PK analysis.
    There are a number of exploratory objectives specified in the protocol and will be assessed up to cut off date 17 January 2012.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetic and Pharmacogenomic Testing:
    Title, version and date: the same as main study X-55-58064-004

    An assessment of genetic polymorphisms in genes which may be involved in BN83495 drug disposition and/or pharmacological effect will be undertaken using baseline blood sample.
    Pharmacogenomic testing will also be undertaken to identify biomarkers potentially predictive of response using microarrays, and to evaluate STS gene expression.
    This will be assessed on available samples and up to the cu--off-date 17 January 2012
    E.3Principal inclusion criteria
    1. Provision of written informed consent prior to any study related procedures.
    2. Post-menopausal or ovariectomised female patients over the age of 18 years with advanced or recurrent endometrial cancer.
    3. Histologically confirmed diagnosis of endometrial carcinoma (primary tumour or metastasis).
    4. Not eligible for surgery or radiotherapy alone, at Investigator's discretion.
    5. Document ER positivity in the primary tumour or in the metastatic tissue if the primary tumour is unavailable (ER positive is defined by at least 10% positive cells).
    6. No other history of malignant disease except treated basal cell or in situ cervical carcinoma in the previous 5 years. In case of previous malignant disease, pathological confirmation of metastatic endometrial cancer will be done at Investigator's discretion.
    7. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
    8. At least one measurable disease site (RECIST criteria version 1.0)
    - minimum indicator lesion size: 20mm (conventional techniques) or 10mm (spiral CT scan)
    - target lesions not situated in irradiated area
    9. Life expectancy ≥6 months.
    10. Adequate organ function as defined by the following criteria:
    - Haemogolobin ≥10g/dL
    - Absolute neutrophil count (ANC) ≥1500/µL
    - Platelets ≥100,000/µl
    - Serum creatinine ≤1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥50 mL/min
    - Serum aspartate aminotransferase (AST) and serum alaline aminotransferase (ALT) ≤2.5x ULN or AST and ALT ≤5x ULN if liver metastases
    - Total serum bilirubin ≤1.5x ULN
    - Serum albumin ≥3.0 g/dL
    - Cardiac function ≤New York Heart Association (NYHA) class II
    11. Patients must have recovered from surgery, radiotherapy and all toxicities of adjuvant chemotherapy treatment if applicable.
    12. Patients must be willing and able to participate in a clinical trial (including the completion of all necessary study procedures).
    13.Patients must be able to swallow oral medication.
    E.4Principal exclusion criteria
    1. Use of any investigational agent in the 4 weeks prior to enrolment in this study
    2. Prior systemic treatment for endometrial cancer (including hormonal treatment, antiangiogenic or targeted therapies) with the exception of chemotherapy in the adjuvant setting having been completed at least 6 months prior to randomisation.
    3. Known central nervous system (CNS) metastases
    4. Ongoing cardiac dysrhythmias of NCI-CTC adverse event (AE) grade ≥ 2, or atrial fibrillation of any grade, or QT interval corrected for heart rate using Fridericia's formulas (QTcF) interval >460 msec
    5. Patients with contraindications to MA including hypersensitivity to one of the components of the drug product, any active arterial or venous thromboembolic event and/or uncontrolled hypertension. Patients receiving anticoagulation for a priot thromboembolic event may be enrolled in the study at Investigator's discretion.
    6. Concomitant use of systemic carbonic anhydrase II inhibitors (e.g. acetazolamide, dichlorphenamide, methazolamide)
    7. History of hypersensitivity to BN83495 or drugs with a similar chemical structure.
    8. Likely to require treatment during the study with drugs that are not permitted by the study protocol (see Section 9.7).
    9. Abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of patients who have neither progressed nor died after 6 months of treatment.

    Response and progression will be evaluated by the investigator (local review) using the international criteria proposed by the RECIST committee (version 1.0). Tumour response will be evaluated every 8 weeks. All responses will be confirmed ≥4 weeks after initially evidenced. Additional blinded central review of responses will be performed up to the cut-off date 17 January 2012.

    In addition, there is a number of secondary efficacy endpoints and evaluations detailed in the protocol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 8 weeks
    E.5.2Secondary end point(s)
    1. The following tumour-related endpoints will be evaluated :
    • Progression Free Survival
    • Clinical benefit
    • Overall response
    • Time to progression
    • Duration of response
    2. Overall Survival at 2 years after the last patient randomised (03 June 2011).
    3. Quality of life
    4. Age-related frailty
    5. Pharmacodynamics: the effects of BN83495 on plasma levels of oestrone (E1), oestrone sulphate (E1S), oestradiol (E2), androstenedione (adione), dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulphate (DHEAS), androstenediol (adiol) and testosterone will be assessed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary efficacy endpoints will be assessed according to the
    protocol defined timepoints.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tumour Assessment via CT scan/MRI
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Moldova, Republic of
    Russian Federation
    Ukraine
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 80
    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)
    Standard medical practice
    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 Decision2009-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-10
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