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    Summary
    EudraCT Number:2009-016858-41
    Sponsor's Protocol Code Number:E7080-G000-204
    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:2010-08-11
    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 number2009-016858-41
    A.3Full title of the trial
    An Open-Label, Single-Arm, Multicenter Phase 2 Study of E7080 in Subjects with Advanced Endometrial Cancer and Disease Progression Following First-Line Chemotherapy
    A.4.1Sponsor's protocol code numberE7080-G000-204
    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 SponsorEisai Ltd.
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 E7080
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeE7080
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 E7080
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeE7080
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Unresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10014736
    E.1.2Term Endometrial cancer recurrent
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10014734
    E.1.2Term Endometrial cancer metastatic
    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 14.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the objective response rate (ORR: complete response + partial response [CR + PR]) of E7080 in subjects with unresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    To assess PFS and OS of subjects in this study population when treated with E7080.
    To assess disease control rate (DCR:CR+PR+SD >=7 weeks); clinical benefit rate (CBR:CR+PR+durable SD >=23 weeks); and durable SD rate.
    To assess safety and tolerability of E7080.
    To assess pharmacokinetics profile and pharmacodynamics of E7080 in subjects with advanced endometrial cancer.

    Exploratory Objectives:
    To explore the effect of E7080 as a function of dose/exposure on tumor volumes
    (i.e., as a biomarker of effect on biological growth rate).
    To assess the anti-angiogenic effect of E7080 on endometrial carcinomas using
    DCE-MRI metrics and the direct anti-tumor effect using DWI-MRI metrics at selected sites.
    To identify and evaluate genetic, blood, and tumor biomarkers with respect to the
    efficacy-related endpoints of this study.
    To identify and evaluate DNA-sequence variants in genes influencing E7080 ADME.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Histologically confirmed diagnosis of endometrial carcinoma.
    2) Radiographic evidence of disease progression according to RECIST 1.1 after 1 prior systemic, platinum-based chemotherapy regimen for metastatic or primary unresectable endometrial carcinoma for which no surgical or radiotherapy treatment options exist. Patients with desease progression within 1 year following completion of platinum-based chemotherapy administered as either adjuvant or neoadjuvant treatment will be eligible without the requirement for further systemic treatment. Patients who have received platinum-based adjuvant or neoadjuvant treatment and have disease progression more than 1 year following treatment must receive 1 additional cytotoxic systemic treatment before being eligible for enrollment in this study.
    3) Measurable disease meeting the following criteria:
    -At least 1 lesion of >/=1.0 cm in the longest diameter for a non-lymph node or >/=1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using CT/MRI. If there is only 1 target lesion, and it is a non-lymph node, it should have a longest diameter of >/=1.5 cm.
    -Lesions that have had EBRT or loco-regional therapies such as RF ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
    4) ECOG performance status </=2
    5) Adequately controlled BP with or without antihypertensive mediciations, defined as BP </=150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit.
    6) Adequate renal function defined as calculated creatinine clearance >/=30 mL/min per the Cockcroft and Gault formula
    7) Adequate bone marrow function:
    -ANC >/=1000/mm3
    -Platelets >/=100,000/mm3
    -Hemoglobin >/=9.0 g/dL
    8) Adequate blood coagulation function as evidenced by an INR </=1.5
    9) Adequate liver function:
    -Bilirubin </=1.5 x ULN except for unconjugated hyperbilirubinaemia of Gilbert's syndrome
    -ALT and AST </=3 x ULN (</=5 x ULN if subject has liver metastases)
    10) Females age >/=18 years at the time of informed consent
    11) Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-hCG test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG). A separate baseline assessment if required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
    12) All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
    13) Females of childbearing potential must not have had unprotected sexual intercourse within 30 days prior to study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation. If currently abstinent, the subject must agree to use a double-barrier method as described above if she becomes sexually active during the study period or for 30 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
    14) Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
    E.4Principal exclusion criteria
    1) Brain or leptomeningeal metastases including stable metastases
    2) More than 1 prior systemic chemotherapy regimen for metastatic or primary unresectable endometrial carcinoma or any teatment targetting VEGF-directed angiogenesis. There is no restriction regarding prior hormonal therapy
    3) Prior systemic anti-tumour therapy within 3 weeks
    4) Not fully recovered from prior radiotherapy based on investigator judgment
    5) Subjects with >1+ proteinuria on urine dipstick will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with 24-hour urine protein >/=1 g will be ineligible
    6) Gastrointestinal malabsorption or any other condition that might affect the absorption of E7080
    7) Inability to take oral medication
    8) Major surgery within 3 weeks prior to the first dose of study drug
    9) Significant cardiobascular impairment: history of congestive heart failure greater than NYHA Class II; unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment
    10) Prolongation of QTc interval to >480 msec
    11) Bleeding disorder or thrombotic disorder requiring anticoagulant therapy, such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin [LMWH] allowed)
    12) Active hemoptysis (bright red blood of at least 1/2 teaspoon) within 3 weeks prior to the first dose of study drug
    13) Known intolerance to the study drug (or any of the excipients)
    14) Any medical of other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
    15) Any malignancy (except for endometrial cancer, basal or aquamos cell carcinoma of the skin, melanoma in situ, or carcinoma in situ of the cervix) in the past 2 years
    16) Previous treatement with an investigational drug withing 30 days prior to the first dose of study drug
    17) Females who are pregnant or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    Objective tumour response rate (CR + PR) based on RECIST 1.1.
    E.5.2Secondary end point(s)
    - Progression-free survival based on RECIST 1.1 and measured as the time from the date of first treatment until the date of first documentation of desease progression or date of death, if death occurs prior to desease progression.
    - Overall survival measured as the time from the date of first treatment until the date of death.
    - CR based on RECIST 1.1.
    - PR based on RECIST 1.1.
    - Desease control rate (CR + PR + SD) based on RECIST 1.1 and minimum duration of SD lasting >/= 7 weeks.
    - Clinical benefit rate (CR + PR + durable SD) based on RECIST 1.1 and SD lasting >/= 23 weeks.
    - Durable SD rate based on RECIST 1.1 and defined as SD lasting >/= 23 weeks.

    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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.8.3 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 EEA29
    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
    Hungary
    Poland
    Romania
    Russian Federation
    Ukraine
    United States
    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
    Last patient, last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    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 months1
    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.1.3Elderly (>=65 years) Yes
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 130
    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 Decision2010-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-10
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