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    Summary
    EudraCT Number:2010-023427-18
    Sponsor's Protocol Code Number:LEOPARDII
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-05-24
    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 - PEI
    A.2EudraCT number2010-023427-18
    A.3Full title of the trial
    Definitive radiochemotherapy with 5-FU / cisplatin plus/minus
    cetuximab in unresectable locally advanced esophageal cancer:
    a phase II study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Definitive radiochemotherapy with 5-FU / cisplatin plus/minus
    cetuximab in unresectable locally advanced esophageal cancer
    A.3.2Name or abbreviated title of the trial where available
    LEOPARD II
    A.4.1Sponsor's protocol code numberLEOPARDII
    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 SponsorUniversity Hospital Schleswig-Holstein, Campus Luebeck
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck KGgA
    B.4.2CountryGermany
    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 Yes
    D.2.1.1.1Trade name Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    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 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 INNCetuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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 locally advanced esophageal cancer
    E.1.1.1Medical condition in easily understood language
    Unresectable locally advanced esophageal cancer
    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 LLT
    E.1.2Classification code 10015362
    E.1.2Term Esophageal cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10030151
    E.1.2Term Oesophageal cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    2-year overall survival
    E.2.2Secondary objectives of the trial
    1-year overall survival
    1-year and 2-year progression-free survival
    1-year and 2-year loco-regional control
    1-year and 2-year metastases-free survival
    Toxicity (NCI-CTC 4.0)
    Overall response rate (RECIST Version 1.1)
    Quality of Life (EORTC QLQ-C30 and QLQ OES18)

    In addition the following parameters will be assessed irrespective of a specific time point:
    • OS
    • PFS
    • MFS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed written informed consent
    • Male or female between 18 and 75 years; patients > 75 years if KPS ≥ 80
    • Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus, which is not curatively resectable
    • KPS ≥ 70
    • Women of child-bearing potential must have a negative pregnancy test
    • Adequate cardiac, pulmonary, and ear function
    • Adequate bone marrow function: leucocytes > 3.0 x 109/L, neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 10.0 g/dL
    • Adequate liver function: Bilirubin < 2.0 mg/dL, SGOT, SGPT, AP, -GT < 3 x ULN
    • Adequate renal function: serum creatinine < 1.5 mg/dL, creatinine clearance > 50 ml/min (calculated value according to Cockroft-Gault equation)
    • No known allergy against chimeric antibodies
    • Effective contraception for both male and female patients if the risk of conception exists
    E.4Principal exclusion criteria
    • Distant metastasis (M1b)
    • Previous treatment of esophageal cancer
    • Previous exposure to monoclonal antibodies and / or EGFR-targeted therapy
    • Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
    • Serious concomitant disease or medical condition
    • FEV1 < 1,1
    • Clinically relevant coronary artery disease or a history of myocardial infarction within the last 12 months or left ventricular ejection fraction (LVEF) below the institutional range of normal
    • Any active dermatological condition > Grade 1
    • Contraindications to receive cisplatin, 5-FU or cetuximab
    • Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
    • Pregnancy or lactation
    • Known active drug abuse/alcohol abuse
    • Social situations limiting the compliance with the study requirements
    E.5 End points
    E.5.1Primary end point(s)
    2-year overall survival (rate)
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years after start of treatment
    E.5.2Secondary end point(s)
    [1] 1-year OS (rate)
    [2]-year and 2-year PFS (rate)
    [3] 1-year and 2-year LC (rate)
    [41] 1-year and 2-year MFS (rate)
    [5] OS, PFS, MFS

    Overall response rate
    Toxicity
    E.5.2.1Timepoint(s) of evaluation of this end point
    [1-4] 1 and 2 years after start of treatment, respectively
    [5] irrespective of a specific time point until 2 years after start of treatment of last patient

    Response rate and toxicity up to end of treatment evaluation (i.e. 16 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 No
    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) 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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    background radiochemotherapy
    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 concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Recuitment will be stopped on 31.12.2016.
    The end of study is reached when the last patient has completed the 2-year Follow-up period, therefore, the latest possible date will be 31.12.2018
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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 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 state78
    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)
    Following the end of treatment evaluation or end of treatment for any other cause, patients will be treated and followed according to the guidelines of the German Cancer Society.
    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 Decision2011-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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