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    Summary
    EudraCT Number:2009-016858-41
    Sponsor's Protocol Code Number:E7080-G000-204
    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:2010-10-26
    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 number2009-016858-41
    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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study of a new drug called E7080 for patients with cancer of the womb that has spread to other parts of the body after having one platinum based chemotherapy. The patients know they are receiving the drug. The study is being carried out in different countries and the safety and effectivenes of E7080 have been studied in other cancer patients.
    A.3.2Name or abbreviated title of the trial where available
    HOPE
    A.4.1Sponsor's protocol code numberE7080-G000-204
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01111461
    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 supportEisai Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Ltd.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressEuropean Knowledge Centre, Mosquito Way
    B.5.3.2Town/ cityHatfield, Hertfordshire
    B.5.3.3Post codeAL109SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44800001 46 12
    B.5.5Fax number+44845676 13 88
    B.5.6E-maillmedinfo@eisai.net
    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.3.1Product nameHOPE
    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.3.8INN - Proposed INNLenvatinib
    D.3.9.2Current sponsor codeE7080
    D.3.9.3Other descriptive nameHOPE
    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) 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 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.3.1Product nameHOPE
    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.3.8INN - Proposed INNLenvatinib
    D.3.9.2Current sponsor codeE7080
    D.3.9.3Other descriptive nameHOPE
    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) 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
    Unresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy
    E.1.1.1Medical condition in easily understood language
    Cancer of the womb that has spread to other parts of the body after having one platinum based chemotherapy.
    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 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 14.1
    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 14.1
    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 14.1
    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
    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 the 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 the safety and tolerability of E7080.
    To assess the 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 tumour 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 validate DNA-sequence variants in genes influencing E7080 ADME.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    MRI assessment sub-study
    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 hemotherapy regimen for metastatic or primary unresectable endometrial carcinoma for which no surgical or radiotherapy treatment options exist. Patients with disease 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 (revised per Amendment 02).
    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 computerized tomography/magnetic resonance imaging (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 (revised per Amendment 02).
    ─ Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency (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 medications defined as BP <150/90mmHg at screening and no change in antihypertensive medications within 1 week prior to Screening Visit.
    6) Adequate renal function defined as calculated creatinine clearance >/=30 mL/min per 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-human chorionic gonadotropin [ß-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. (revised per Amendment 02)
    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) (revised per Amendment 02).
    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 [such as condom plus diaphragm with spermicide], 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 (Revised per Amendment 02).
    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 treatment targeting vascular endothelial growth factor (VEGF)-directed angiogenesis. There is no restriction regarding prior hormonal therapy (revised per Amendment 02).
    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 testing 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 cardiovascular 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 disorders requiring anticoagulant therapy such as warfarin or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin LMWH allowed)
    12) Active haemoptysis (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 squamous cell carcinoma of the skin, melanoma in situ, or carcinoma in situ of the cervix) in the past 2 years (revised per Amendments 01 and 02).
    16) Previous treatment 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 tumor response rate (CR + PR) based on RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    All response rates will be based on RECIST 1.1. The ORR in Stage I of Simon’s Optimal Two-Stage Design will be determined while the first 47 subjects (Per Protocol Population) complete a minimum of 6 cycles of treatment (or have discontinued study drug prior to completing 6 cycles). This analysis will be based on investigator assessments of tumor response to decide if the study should continue enrollment to complete Stage II. The final analysis of ORR will utilize tumor response assessments as determined by independent radiologic review (IRR). Data cut-off for the final (primary) analysis will occur at the end of the Treatment Phase. This analysis will be performed on the Full Analysis Population (ITT Analysis Set).
    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 disease progression or date of death, if death occurs prior to disease 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.

    Disease 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS estimated as the time from the date of first treatment to the date of first documentation of disease progression or date of death, if death occurs prior to disease progression;

    OS measured as the time from the date of first treatment to the date of death;

    DCR with the duration of SD lasting >7 weeks;

    CBR with the duration of SD lasting >23 weeks;

    Durable SD rate with the 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    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
    LVLS
    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 months10
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 130
    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)
    Subjects who are receiving study drug at the end of the Treatment Phase will continue to receive study drug during treatment cycles in the Extension Phase. Subjects will remain on treatment in consecutive 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation of E7080 development by the Sponsor. Off-treatment assessments will occur within 30 days following the final study treatment.
    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 Decision2010-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-10
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