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    Summary
    EudraCT Number:2014-003951-72
    Sponsor's Protocol Code Number:GOIRC02/2014
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-01-15
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-003951-72
    A.3Full title of the trial
    Phase II randomized multicenter study of Everolimus as maintenance therapy for metastatic neuroendocrine carcinoma with pulmonary or gastroenteropancreatic origin.
    Studio multicentrico randomizzato di fase II per la valutazione di Everolimus come terapia di mantenimento per Il trattamento dei pazienti con carcinoma neuroendocrino di origine polmonare e gastroenteropancreatica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    evaluation of the activity of Everolimus as maintenance therapy for metastatic neuroendocrine carcinoma with pulmonary or gastroenteropancreatic origin.
    Valutazione dell'attività di Everolimus come terapia di mantenimento per Il trattamento dei pazienti con carcinoma neuroendocrino di origine polmonare e gastroenteropancreatica
    A.3.2Name or abbreviated title of the trial where available
    MAVERIC
    MAVERIC
    A.4.1Sponsor's protocol code numberGOIRC02/2014
    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 SponsorGruppo Oncologico Italiano Ricerca Cancro (GOIRC)
    B.1.3.4CountryItaly
    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 supportGOIRC
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportNOVARTIS
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGOIRC
    B.5.2Functional name of contact pointUfficio Trials clinici
    B.5.3 Address:
    B.5.3.1Street AddressLargo Brambilla 3
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code50134
    B.5.3.4CountryItaly
    B.5.4Telephone number390557949648
    B.5.5Fax number390557947538
    B.5.6E-maillorenzo.antonuzzo@gmail.com
    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 AFINITOR®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm LTD
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameAFINITOR®
    D.3.4Pharmaceutical form Capsule
    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 INNEverolimus
    D.3.9.1CAS number 159351-69-6
    D.3.9.2Current sponsor codeABI-007
    D.3.9.3Other descriptive nameEVEROLIMUS
    D.3.9.4EV Substance CodeSUB02065MIG
    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.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 AFINITOR®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm LTD
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameAFINITOR®
    D.3.2Product code L01XE10
    D.3.4Pharmaceutical form Capsule
    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 INNEverolimus
    D.3.9.1CAS number 159351-69-6
    D.3.9.3Other descriptive nameEVEROLIMUS
    D.3.9.4EV Substance CodeSUB02065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    The aim of this study is to evaluate the activity of a maintenance therapy with everolimus 10 mg daily in patients with stable disease, partial response or complete response after 6 cycles of induction chemotherapy with cisplatin or carboplatin plus etoposide administered according to clinical practice.
    L'obiettivo dello studi è quello di valutare l'attività di everolimus come terapia di mantenimento con everolimus 10 mg al giorno in pazienti con malattia stabile, in risposta parziale o completa dopo 6 cicli di chemioterapia con cisplatino ed etoposide somministrata in accordo con la pratica clinica
    E.1.1.1Medical condition in easily understood language
    patients with neuroendocrine carcinoma with ki 67 less then 55%
    valutare l’attività di Everolimus in termini di PFS nella terapia di mantenimento di pazienti con carcinoma neuroendocrino con ki 67 inferiore al 55%.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary endpoint is progression free survival (PFS) defined as
    the time between randomization and the first evidence of progressive disease or date of death, whichever occurs first. Documentation of disease progression will be defined as per RECIST 1.1 criteria based on investigator assessment. The censoring date for a patient who is known to be progression-free would be the date of the last tumor assessment.
    Obiettivo principale: valutare l’attività di Everolimus in termini di PFS nella terapia di mantenimento di pazienti con carcinoma neuroendocrino ad origine gastroentero¬¬ pancreatica o polmonare con ki 67 inferiore al 55% in stabilita di malattia, risposta parziale o completa dopo 6 cicli di trattamento chemioterapico di prima linea con Cisplatino e VP 16.
    E.2.2Secondary objectives of the trial
    Overall survival (OS) defined as the time from randomization to death from any cause
    Safety profile: Safety of the treatment will be evaluated by serious and non serious adverse events (AEs). AEs will be graded according to the CTCAE v4.03
    Evaluation of prognostic/predictive factors on tumoral tissue and blood samples of patients treated with maintenance Everolimus:
    Sopravvivenza globale (OS), profilo di sicurezza, ricerca di fattori prognostici e predittivi sul tessuto tumorale e sul sangue periferico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients may be included in the study if they meet all of the following criteria:
    • Histological / cytological diagnosis of GEP Neuroendocrine Carcinoma (NEC) with Ki67< 55% (WHO 2010)
    • Histological/cytological diagnosis of large-cells neuroendocrine carcinoma of the lung with Ki67 <55%;
    • Stable disease, partial response or complete response (Recist 1.1) after 6 cycles of first line chemotherapy with Cisplatin plus Etoposide
    • non functional NEC
    • locally advanced inoperable or metastatic disease
    • measurable or evaluable disease according to RECIST criteria (version 1.1)
    • Age> 18;
    • ECOG performance status ≤ 2;
    • Adequate bone marrow function (Hb> 9.0 g / dL, absolute neutrophil count> 1.5 x 109 / L, platelets> 100 x 109 / L), renal function (serum creatinine <2 mg / dL x ULN or creatinine clearance, Cockroft formula, ≥ 30 ml / min), hepatic function (serum bilirubin <1.5 x ULN, serum transaminases <2.5 x ULN in the absence of liver metastases or <5x ULN in the presence of liver metastases);
    • Negative pregnancy test or breastfeeding women during childbearing age;
    • Written informed consent;
    • Approval of the Ethics Committee that will be required.
    diagnosi istologica o citologica di GEP NEC con Ki67< 55% (WHO 2010) large-carcinoma neuroendocrino del polmone con Ki67 <55%; malattia stabile, in risposta parziale o complete (Recist 1.1) dopo 6 cicli di chemioterapia di prima linea con Cisplatino piu Etoposide, NEC non funzionante, malattia misurabile, età> 18; ECOG performance status ≤ 2; adeguata funzionalità d’organo.
    E.4Principal exclusion criteria
    • clinically significant cardiovascular disorders in the 6 months prior to randomization (congestive heart failure, myocardial infarction, unstable angina, severe uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular accidents, pulmonary thromboembolism);
    • Functional Neuroendocrine Carcinoma NEC
    • Neuroendocrine carcinoma with ki 67 > 55%
    • ongoing uncontrolled infection;
    • Concomitant intake of:
    - Drugs incompatible with concomitant everolimus;
    - Any other drug in clinical trials;
    • History of other malignancy except carcinoma in situ of the cervix or basal / squamous cell carcinoma of the skin adequately treated;
    • Presence of brain metastases;
    • Any other serious or uncontrolled concurrent disease conditions that the safe administration of medications
    disordini cardiovascolari clinicamente significativi nei 6 mesi precedenti la randomizzazione (insufficienca cardica congestizia, infarto del miocardio, angina instabile, aritmie cardiache non controllate, NEC funzionanti, ki 67 > 55%, infezioni non controllate in atto.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS)
    Progression free survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi
    E.5.2Secondary end point(s)
    Overall survival (OS), safety profile, evaluation of prognostic/predictive factors on tumoral tissue and blood samples
    Sopravvivenza globale (OS), profilo di sicurezza, ricerca di fattori prognostici e predittivi sul tessuto tumorale e sul sangue periferico
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 months for OS and during maintenace treatment for safety profile and
    evaluation of prognostic/predictive factors on tumoral tissue and blood samples
    10 mesi per la sopravvivenza globale e durante la terapia di mantenimento per profilo di sicurezza, ricerca di fattori prognostici e predittivi sul tessuto tumorale e sul sangue periferico
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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.8.2.4Number 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 concerned5
    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 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 the trials is extimated after 36 months from the first patient randomized
    La fine dello studio è stimata circa 36 mesi dopo la randomizzazione del primo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state30
    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)
    follow-up or treatments according to local guidelines
    follow-up o trattamenti attivi in accordo alle linee guida nazionali
    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 Decision2015-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-20
    P. End of Trial
    P.End of Trial StatusOngoing
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