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    The EU Clinical Trials Register currently displays   42316   clinical trials with a EudraCT protocol, of which   6969   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-005199-27
    Sponsor's Protocol Code Number:E7080-G000-211
    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:2016-04-26
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-005199-27
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind Phase 2 Trial of Lenvatinib (E7080) in Subjects with 131I-Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 20 mg or 14 mg Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 trial to determine if there is a lower starting dose of lenvatinib (20mg or 14mg daily) that will cause fewer side effects and work as well as a 24mg starting dose in treating adults with thyroid cancer, who are not responding to treatment, or whose cancer has reappeared following an initial recovery.
    A.4.1Sponsor's protocol code numberE7080-G000-211
    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 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 supportEisai Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Limited
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressMosquito Way
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+440845 676 1400
    B.5.5Fax number+440845 676 1401
    B.5.6E-mailEUMedInfo@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 Yes
    D.2.1.1.1Trade name LENVIMA
    D.2.1.1.2Name of the Marketing Authorisation holderEisai Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1121 & 1119
    D.3 Description of the IMP
    D.3.1Product namelenvatinib
    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.3.9.1CAS number 417716-92-8
    D.3.9.2Current sponsor codeE7080
    D.3.9.3Other descriptive nameLENVATINIB
    D.3.9.4EV Substance CodeSUB64419
    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 Yes
    D.2.1.1.1Trade name LENVIMA
    D.2.1.1.2Name of the Marketing Authorisation holderEisai Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1121 & 1119
    D.3 Description of the IMP
    D.3.1Product namelenvatinib
    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.3.9.1CAS number 417716-92-8
    D.3.9.2Current sponsor codeE7080
    D.3.9.3Other descriptive nameLENVATINIB
    D.3.9.4EV Substance CodeSUB64419
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    131I-refractory differentiated thyroid cancer (DTC)
    E.1.1.1Medical condition in easily understood language
    Advanced thyroid cancer which no longer responds to radioactive iodine therapy.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10066474
    E.1.2Term Thyroid 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether a starting dose of lenvatinib 20 mg or 14 mg once daily (QD) will provide comparable efficacy (based on ORR6M) with an improved safety profile compared to 24 mg QD (based on treatment-emergent adverse events [TEAEs] of Grade 3 or higher in the first 6 months after randomization).
    E.2.2Secondary objectives of the trial
    To evaluate PFS in subjects treated with lenvatinib doses of 24 mg, 20 mg, and 14 mg QD.
    To evaluate the PFS after next line of treatment (PFS2) in subjects treated with lenvatinib doses of 24 mg, 20 mg, and 14 mg QD.
    To evaluate the safety and tolerability of lenvatinib doses of 24 mg, 20 mg, and 14 mg QD.
    To evaluate the pharmacokinetic (PK)/pharmacodynamic relationship between exposure and biomarkers/efficacy/safety.
    To evaluate the impact of lenvatinib treatment on Health-Related Quality of Life (HRQoL) as measured by the instruments EQ-5D-3L and FACT-G.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must have histologically confirmed diagnosis of one of the following differentiated thyroid cancersubtypes:
    a. Papillary thyroid cancer ◦ 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 ◦ Hürthle cell ◦ Clear cell ◦ Insular
    2. Measurable disease meeting the following criteria and confirmed by central radiographic review:
    a. 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 that 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.
    b. Lesions that have had external beam radiotherapy or locoregional therapies such as radiofrequency ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
    3. Subjects must show evidence of disease progression within 12 months (an additional month will be allowed to accommodate actual dates of performance of screening scans, ie, within ≤13 months) prior to signing informed consent, according to RECIST 1.1 assessed and confirmed by central radiographic review of CT and/or MRI scans.
    4. Subjects must be 131I-refractory/resistant as defined by at least one of the following:
    a. One or more measurable lesions that do not demonstrate iodine uptake on any radioiodine scan.
    b. One or more measurable lesions that have progressed according to RECIST 1.1 within 12 months after 131I therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre- or posttreatment scanning. These subjects must not be eligible for possible curative surgery.
    c. Cumulative activity of 131I of >600 mCi or 22 GBq, with the last dose administered at least 6 months prior to study entry.
    5. Subjects with known brain metastases who have completed whole brain radiotherapy, stereotactic radiosurgery or complete surgical resection, if they have remained clinically stable, asymptomatic, and off steroids for one month.
    6. Subjects must be receiving thyroxine suppression therapy and TSH should not be elevated (TSH should be ≤5.50 mCi/mL).When tolerated by the subject, thyroxine dose should be changed to achieve TSH suppression.
    7. All chemotherapy- or radiation-related toxicities must have resolved to Grade <2 severity per CTCAE v4.03, except alopecia and infertility. 8. Subjects must have an ECOG Performance Status of 0, 1 or 2.
    9. Adequately controlled blood pressure with or without antihypertensive medications, defined as BP ≤150/90 mmHg at Screening and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1.
    10. Adequate renal function defined as calculated creatinine clearance ≥30 mL/min per the Cockcroft and Gault formula. 11. Adequate bone marrow function: a. Absolute neutrophil count ≥1500/mm3 b. Platelets ≥100,000/mm3 c. Hemoglobin ≥9.0 g/dL 12. Adequate blood coagulation function INR ≤1.5.
    13. Adequate liver function: a. Bilirubin ≤1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert’s syndrome. b. Alkaline phosphatase, ALT, and AS ≤3 × ULN (≤5 × ULN if subject has liver metastases). If alkaline phosphatase is >3 × ULN (in absence of liver metastases) or >5 × ULN (in presence of liver metastases) AND the subject also is known to have bone metastases, the liver-specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of total alkaline phosphatase.
    14. see protocol
    15. see protocol
    16. see protocol
    17. Females of childbearing potential should avoid becoming pregnant and use highly effective contraception while on treatment with lenvatinib and for at least 1 month after finishing treatment. Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, 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. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation. Women using oral hormonal contraceptives should add a barrier method.
    18. Subject must voluntarily agree to provide written informed consent.
    19. Subject must be willing and able to comply with all aspects of the protocol.
    E.4Principal exclusion criteria
    1. Anaplastic or medullary carcinoma of the thyroid.
    2. Diagnosed with meningeal carcinomatosis.
    3. Two or more prior VEGF/VEGFR-targeted therapies or any ongoing treatment for RR-DTC other than TSH-suppressive thyroid hormone therapy.
    4. Prior treatment with lenvatinib.
    5. Subjects who have received any anticancer treatment within 21 days or any investigational agent within 30 days (or 5 half-lives) prior to the first dose of study drug and should have recovered from any toxicity related to previous anticancer treatment. This does not apply to the use of TSH-suppressive thyroid hormone therapy.
    6. Major surgery within 3 weeks prior to randomization or elective surgery scheduled to performed during the study.
    7. Subjects having >1+ proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥1 g/24 h will be ineligible.
    8. Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of study drug.
    9. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (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 corrected QT interval (QTc) to >480 ms as demonstrated by a repeated
    electrocardiogram (ECG) or a clinically significant ECG abnormality, including a marked
    prolonged QT/QTc interval (eg, a repeated demonstration of a QTc interval >500 ms).
    11. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
    12. Active infection (any infection requiring treatment).
    13. Active malignancy (except for DTC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months.
    14. Known intolerance to study drug (or any of the excipients).
    15. Any medical or other condition that in the opinion of the investigator(s) would preclude the subject’s participation in a clinical study.
    16. Females who are pregnant or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    - ORR6M as assessed by investigator using RECIST 1.1. ORR6M is defined as the proportion of subjects with BOR of CR or PR at the Week 24 time point or earlier.
    - Rate of TEAE with CTCAE grades of 3 or higher within 6 months after randomization (as of the Week 24 time point).
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR6M as assessed by investigator using RECIST 1.1. Rate of TEAE with CTCAE grades of 3 or higher within 6 months after randomization (as of the Week 24 time point).
    E.5.2Secondary end point(s)
     PFS, defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurs first. PFS
    censoring rules will be defined in the SAP and will follow FDA guidance.
     PFS2, defined as the time from randomization to second objective disease progression,
    or death from any cause, whichever occurs first.
     Overall safety profile and tolerability.
     Time to treatment discontinuation due to an AE.
     Number of dose reductions.
     Time to first dose reduction.
     Plasma PK lenvatinib exposure parameters.
     Inter-relationships of lenvatinib exposure, changes in thyroglobulin and/or TSH, other
    exploratory serum biomarkers, and changes in tumor burden and PFS.
     Relationship of lenvatinib exposure and changes in BP, and AEs of weight loss, fatigue,
    nausea, vomiting, diarrhea, and proteinuria CTCAE grades derived from urine protein
    measurements.
     Impact of lenvatinib treatment on HRQoL as assessed using the validated instruments
    EQ-5D-3L and FACT-G.
    E.5.2.1Timepoint(s) of evaluation of this end point
    lPFS at the time of disease progression/patient death, PFS2 at the time of disease progression/patient death, overal safety and tolerability at every subject visit
    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 Yes
    E.6.10Pharmacogenetic No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    different dose of same IMP
    E.8.2.4Number of treatment arms in the trial3
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Australia
    Austria
    Belgium
    Canada
    Denmark
    France
    Germany
    Israel
    Italy
    Poland
    Portugal
    Romania
    Russian Federation
    Spain
    Sweden
    United Kingdom
    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
    The End of Study will occur at the end of the Randomization Phase,
    which is defined as when the last subject enrolled completes the Week 24 tumor assessments or discontinues study treatment before Week 24.
    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 months6
    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 months6
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 300
    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)
    After the primary analysis, subjects still receiving study treatment may continue taking lenvatinib available through their pharmacy (if commercially available for that individual subject) or through an access program administered by the sponsor.
    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 Decision2017-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-08
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