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    Summary
    EudraCT Number:2012-005546-38
    Sponsor's Protocol Code Number:AEZS-108-050
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-005546-38
    A.3Full title of the trial
    Randomized controlled study comparing AEZS-108 with doxorubicin as second line therapy for locally advanced, recurrent or metastatic endometrial cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial with AEZS-108 in a certain stage of endometrial tumor
    A.3.2Name or abbreviated title of the trial where available
    AEZS-108 and doxorubicin in patients with endometrial cancer
    A.4.1Sponsor's protocol code numberAEZS-108-050
    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 SponsorAeterna Zentaris GmbH
    B.1.3.4CountryGermany
    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 supportAeterna Zentaris GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAeterna Zentaris GmbH
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street AddressWeismüllerstrasse 50
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post codeD-60314
    B.5.3.4CountryGermany
    B.5.4Telephone number+4969426023429
    B.5.5Fax number+4969426023404
    B.5.6E-mailclinical.trials@aezsinc.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 AEZS-108
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZoptarelin doxorubicin
    D.3.9.1CAS number 139570-93-7
    D.3.9.2Current sponsor codeAEZS-108
    D.3.9.3Other descriptive nameZEN-008
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.2.5The 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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICIN
    D.3.9.1CAS number 23214-92-8
    D.3.9.4EV Substance CodeSUB06391MIG
    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
    Endometrial cancer, advanced, recurrent or metastatic
    E.1.1.1Medical condition in easily understood language
    special type of gynecologic cancer that arises from the endometrium, or lining, of the uterus
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10014741
    E.1.2Term Endometrial cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10014740
    E.1.2Term Endometrial cancer stage III
    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
    Compare the overall survival (OS) of patients treated with AEZS-108 to the overall survival of patients treated with doxorubicin
    E.2.2Secondary objectives of the trial
    Compare efficacy based on progression-free survival (PFS), overall response rate (ORR), and clinical benefit rate (CBR). Compare safety. Determine the impact of these regimens on patient-reported quality of life.
    Sub-study (selected study sites only): Assess pharmacokinetics and exposure-response relationships of AEZS-108, doxorubicin, and doxorubicinol.
    Assess acute effects of AEZS-108 and doxorubicin on
    electrocardiographic Parameters.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Randomized controlled study comparing AEZS-108 with doxorubicin as second line therapy for locally advanced, recurrent or metastatic endometrial cancer

    Pharmacokinetic sub-study in patients treated with AEZS-108, Version 0, date: 2013-05-02
    E.3Principal inclusion criteria
    1. Woman ≥ 18 years of age
    2. Histologically confirmed endometrial adenocarcinoma of any subtype.
    a) Endometrioid carcinoma
    i.Variant with squamous differentiations
    ii.Villoglandular variant
    iii.Secretory variant
    iv.Ciliated cell variant
    b) Mucinous adenocarcinoma
    c) Serous adenocarcinoma
    d) Clear cell adenocarcinoma
    e) Mixed cell adenocarcinoma
    f) Squamous cell carcinoma
    g) Transitional cell carcinoma
    h) Small cell carcinoma
    i) Undifferentiated carcinoma
    3. Advanced (FIGO stage III or IV), recurrent or metastatic disease.
    4. Measurable or non-measurable disease that has progressed since last treatment.
    5. Patients with advanced, recurrent or metastatic endometrial cancer who have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or as first line treatment) and who have progressed.
    6. Availability of fresh or archival FFPE tumor specimens for analysis of LHRH receptor expression.
    E.4Principal exclusion criteria
    1. Eastern Cooperative Oncology Group (ECOG) performance status > 2
    2. Inadequate hematologic, hepatic or renal function
    - thrombocyte count: < 100 x 109/L;
    - absolute neutrophil count (ANC): < 1.5 x 109/L;
    - hemoglobin: < 5.6 mmol/L (< 9 g/dL);
    - ASAT, ALAT, AP: > 2.5 times upper limit of normal range (ULN) (> 5x ULN if clearly related to liver metastases);
    - creatinine, bilirubin: > 1.5x ULN.
    3. Red blood cell transfusion within 2 weeks prior to anticipated start of study treatment.
    4. History of myocardial infarction, acute inflammatory heart disease, unstable angina, or uncontrolled arrhythmia within the past 6 months.
    5. Impaired cardiac function defined as left ventricular ejection fraction (LVEF) < 50% (or below the study site’s lower limit of normal) as measured by MUGA or ECHO.
    6. Concomitant use of prohibited therapy (as specified in Section 6.3.2 in the protocol).
    7. Chemo-, immune-, hormone-therapy within 5 elimination half life times or 4 weeks prior to randomization whichever is the shortest. Radiotherapy (including pre- or post-operative brachytherapy) within 4 weeks prior to randomization .
    8. Previous anthracycline-based chemotherapy (daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone and valrubicin), in any formulation.
    9. Anticipated ongoing concomitant anticancer therapy during the study.
    10. History of serious co-morbidity or uncontrolled illness that would preclude study therapy, such as active tuberculosis or any other active infection.
    11. Brain metastasis, leptomeningeal disease.
    12. Pregnant or lactating female or female of child-bearing potential not employing adequate contraception. Women of childbearing potential must agree to employ adequate contraception until 6 months after the last dose of study drug, defined as
    - complete abstinence (Note: acceptable only as “True abstinence”, i.e. when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence, e.g., calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal are not acceptable methods of contraception);
    - any intrauterine device (IUD) with published data showing that the lowest expected failure rate is < 1% per year; or
    - any other methods with published data showing that the lowest expected failure rate is less than 1% per year.
    13. Subjects with known hypersensitivity to anthracyclines or peptide drugs, including LHRH agonists.
    Lack of suitability for the trial:
    22. Malignancies arising from the uterine Cervix.
    23. Uterine sarcomas or mixed epithelial and mesenchymal Tumors including carcinosarcoma, adenosarcoma, or carcinofibroma.
    14. Receipt of 2 or more prior cytotoxic chemotherapy regimens for advanced, recurrent, or metastatic endometrial cancer.
    15. Prior treatment with AEZS-108.
    16. Use of LHRH agonist or antagonist treatment within 6 months prior to randomization.
    17. Malignancy within last 5 years except non-melanoma skin cancer.
    18. Any concomitant disease or condition which would interfere with the subjects’ proper completion of the protocol assignment.
    19. Concomitant or recent treatment with other investigational drug (within 4 weeks or 5 elimination half life times prior to anticipated start of study treatment).
    20. and 21. Administrative reasons
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (primary efficacy endpoint).
    2a Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clinical benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.
    2b. Safety: adverse events, clinical laboratory, ECG and LVEF.
    2c. Quality of Life: EORTC QLQ30 + QLQ-EN24 questionnaires.
    Pharmacokinetic and electrocardiographic parameters of the PK substudy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of the primary efficacy variable will be based on the ITT population. The final overall survival analysis, which is event-based, will be conducted after approximately 384 randomized patients have died.
    E.5.2Secondary end point(s)
    Efficacy based on progression-free survival (PFS), overall response rate (ORR), and clinical benefit rate (CBR).
    Safety: adverse events, clinical laboratory and LVEF.
    Quality of Life: EORTC QLQ30 + QLQ-EN24 questionnaires.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis of the primary efficacy variable will be based on the ITT population. The final overall survival analysis, which is event-based, will be conducted after approximately 384 randomized patients have died.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Austria
    Belarus
    Belgium
    Bosnia and Herzegovina
    Bulgaria
    Canada
    Czech Republic
    Denmark
    Germany
    Ireland
    Israel
    Italy
    Netherlands
    Norway
    Poland
    Romania
    Russian Federation
    Spain
    Ukraine
    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 years3
    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 years3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 500
    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)
    For a patient who requires further treatment for her malignant disease, after the end of study treatment with AEZS-108 or doxorubicin, the selection and timing of such treatment is at the discretion of the investigator. There is no standard of care treatment in these cases, he/she will take into account the current signs and symptoms of the disease and, where applicable, any persisting drug-related adverse events (i.e., causality at least possibly related).
    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 Decision2013-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-02
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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