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    Summary
    EudraCT Number:2007-005933-12
    Sponsor's Protocol Code Number:E7080-G000-201
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-005933-12
    A.3Full title of the trial
    Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology.
    A.4.1Sponsor's protocol code numberE7080-G000-201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEisai Limited
    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.3.1Product nameHOPE
    D.3.2Product code E7080
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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
    Medullary thyroid cancer [MTC] or radioiodine (131*I) refractory/resistant differentiated thyroid cancer[DTC]:
    Determine the pharmacokinetic (PK) profile and the pharmacokinetic/pharmacodynamic (PK/PD) relationships of E7080.

    Note: *= to the power.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In patients with medullary thyroid cancer [MTC] or radioiodine (131*I) refractory/resistant differentiated thyroid cancer[DTC]:
    • Determine the effect of E7080 on the objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) by independent imaging review (IIR).
    Note: * = to the power.
    E.2.2Secondary objectives of the trial
    Determine the effect of E7080 on duration of response by IIR, Measure effect on the disease control rate (DCR) and clinical benefit rate by IIR, Determine time to response by IIR, Evaluate effect on progression free survival by IIR and overall survival, Evaluate safety and tolerability, Determine PK profile and PK/PD relationship, Assess the influence of DNA sequence variants on metabolic enzymes and transporters possibly involved in variability of PK parameters, Determine biochemical response using tumor markers (thyroglobulin for DTC patients or calcitonine and CEA for MTC patients), Assess effect of somatic DNA sequence variants in BRAF, H-, Kand N-Ras and RET/PTC1, 2 and 3 and germline DNA sequence variants in RET and near FOXE1(rs965513) and NKX2-1 (rs944289) on patient response to study treatment, Investigate potential correlation of the following biomarkers with efficacy: Serum proteome expression, Serum biomarkers of apoptosis (CASP 3/7, Cytochrome C and M-30 neo-antigen)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the inclusion criteria to be eligible to participate in this study.
    1. Patients must have histologically or cytologically confirmed diagnosis of one of the following:
    A. DTC, including any of the following subtypes:
    a. Papillary thyroid cancer (PTC).
    • Follicular variant.
    • Variants (including but not limited to tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin’s-like, trabecular, tumor with nodular fasciitis-like stroma, Hürthle cell variant of papillary carcinoma, poorly differentiated)
    b. Follicular thyroid cancer (FTC)
    • Hürthle cell
    • Clear cell
    • Insular
    B. MTC
    2. Measurable disease meeting the following criterion:
    a.At least 1 lesion (≥ 1.5 cm in longest diameter for non-lymph nodes and ≥2.0 cm in longest diameter for lymph nodes) which is serially and accurately measurable according to Modified RECIST using either CT/MRIRadiographically
    b.Lesions that have had EBRT must show evidence of progressive disease based on Modified RECIST to be deemed a target lesion
    3. Patients must show evidence of disease progression by RECIST using site assessment of CT/MRI scans within 12 months (+1 month to allow for variances in patient scanning intervals) prior to study entry.
    4. Patients with DTC must be 131*I refractory/resistant as defined by at least one of the following:
    a. One or more measurable lesions that have never demonstrated 131*I uptake on any radioiodine scan based on either collected scans or reports,
    b. One or more measurable lesions with disease progression by RECIST within 12 months (+1 month to allow for variances in patient scanning intervals) of 131I therapy despite 131*I uptake on radioiodine scan based on site assessment of CT/MRI scans.
    c. Cumulative activity of 131*I of >600 mCi or 22 gigabequerel (GBq), with the last dose administered at least 6 months prior to study entry.
    5. Patients must have unresectable disease. Patients must not be amenable to surgery.
    6. Patients with DTC must be receiving thyroxine suppression therapy and TSH should not be elevated (TSH > 5.50 mcu/mL). When tolerated by the patient, thyroxine dose should be changed to achieve TSH suppression (TSH < 0.50 mcu/mL) and this dose can be changed concurrently upon starting E7080.
    7. Patients must not have had chemotherapy, major surgery, monoclonal antibody therapy or experimental therapy within the 30 days prior to the start of E7080 administration (6 weeks for nitrosoureas or mitomycin C).
    • Prior exposure to receptor tyrosine kinase inhibitors and antiangiogenic agents (including but not limited to AEE788, AG-013736, AMG706, AZD2171, bevacizumab, CP-547,632, dasatinib, enzataurin, imatinib mesylate, lenalidomide, pazopanib, sorafenib, sunitinib, thalidomide, vatalanib [PTK787/ZK 222584], VEGF Trap, and ZD6474) are allowed with at least 30 days between this therapy and the start of E7080 treatment.
    8. All chemotherapy or radiation-related toxicities must have resolved to < Grade 2 severity, except alopecia and infertility.
    9. Prior thyroidectomy is allowed.
    10. Blood pressure should be well controlled (≤140/90 mm Hg at Pre-treatment) with or without antihypertensive medications.
    11. Patients must be aged ≥18 years.
    12. Patients must have an ECOG Performance Status of 0 to 2.
    13. Patients must have signed a written informed consent prior to any study specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
    14. Patients must be willing and able to comply with the protocol guidelines for the duration of the study.
    Note: * = to the power.
    E.4Principal exclusion criteria
    Patients with any one of the following are not eligible to participate in this study:
    1. Anaplastic thyroid carcinoma, thyroid lymphoma, mesenchymal tumors of the thyroid, metastases to the thyroid.
    2. Any of the following laboratory measurements:
    a. hemoglobin < 9 g/dL (5.6 mmol/L) (may be corrected with growth factor or transfusions);
    b. neutrophils < 1.5 x 10*9/L; platelets < 100 x 10*9/L.
    c. bilirubin > 1.5 times the upper limit of normal (ULN) and other liver function tests (AST, ALT and alkaline phosphatase) with values greater than three times ULN; (in the case of liver metastases > five times ULN). If alkaline phosphatase is greater than three times the ULN (in the absence of liver metastasis) or greater than five times the ULN (in the presence of liver metastasis), and the patient is known to have bone metastasis, the liver specific alkaline phosphatase must be separated from the total and the liver specific alkaline phosphatase alone should be used to assess liver function.
    d. renal function with serum creatinine > 1.5 ULN and/or creatinine clearance < 60 mL/min per the Cockcroft and Gault formula.
    3. Significant cardiovascular impairment (history of congestive heart failure > NYHA Class II, unstable angina or myocardial infarction within 6 months of study start, or serious cardiac arrhythmia).
    4. Active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to study entry.
    5. Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, with a therapeutic international normalized ratio (INR).
    6. Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection.
    7. Organ allografts requiring immunosuppressive treatment
    8. Prior malignancy, other than non-melanoma skin cancer or cervical carcinoma in situ, unless the prior malignancy was diagnosed and definitively treated ≥ 5 years previously with no subsequent evidence of recurrence
    9. Brain or leptomeningeal (central nervous system [CNS]) metastases.
    Patients with stable or previously irradiated brain metastases are also excluded
    10. Marked baseline prolongation of QT/QTc interval (QTc interval ≥ 500 msec) using the Fridericia method (QTc = QT/RR0*.33) for QTc analysis
    11. > 1+ proteinuria on urine dipstick testing or >30 mg/dL
    12. History of gastrointestinal malabsorption or having undergone surgery requiring gastrointestinal anastomoses within 4 weeks of starting therapy or who have not recovered from major surgery within 4 weeks of starting therapy.
    13. Women who are pregnant or breast-feeding; women of childbearing potential with a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception (including two forms of contraception, one of which must be a barrier method) in the opinion of the investigator.
    • Perimenopausal women must be amenorrheic for at least 12 months to be considered of non childbearing potential.
    • Fertile males with female partners who are not willing to use contraception or whose female partners are not using adequate contraceptive protection are excluded.
    14. Other significant disease or disorder that, in the investigator’s opinion, would exclude the patient from the study.
    15. Previous E7080 therapy.
    16. Previous treatment with an investigational drug, with the exception of those identified in inclusion criteria 8, within the 30 days prior to the start of E7080 administration.
    18. History of alcoholism, drug addiction, psychiatric or psychological condition, or social situation which, in the opinion of the investigator, would impair study compliance.
    19. Legal incapacity.
    Note: * = to the power.
    E.5 End points
    E.5.1Primary end point(s)
    Key outcomes measured
    • Overall tumor response rates of complete response (CR), and partial response (PR) based on modified RECIST assessed by IIR.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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.1.3Elderly (>=65 years) Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 100
    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 Decision2009-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-18
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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