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    Summary
    EudraCT Number:2005-004605-29
    Sponsor's Protocol Code Number:ML19537
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-004605-29
    A.3Full title of the trial
    A Phase IIIb Study of Tarceva (Erlotinib) in patients with locally advanced, unresectable or metastatic pancreatic cancer
    Studio Clinico di Fase IIIb in pazienti con carcinoma del pancreas ad uno stadio localmente avanzato, non resecabile o in metastasi, trattati con Tarceva (erlotinib)
    A.3.2Name or abbreviated title of the trial where available
    TARCEVA - EAP in pancreatic carcinoma
    TARCEVA - EAP nel carcinoma del pancreas
    A.4.1Sponsor's protocol code numberML19537
    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 SponsorROCHE
    B.1.3.4CountryItaly
    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 Yes
    D.2.1.1.1Trade name Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LTD
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Film-coated tablet
    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 INNErlotinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number100
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LTD
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Film-coated tablet
    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 INNErlotinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number25
    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
    Locally advanced, unresectable or metastatic pancreatic cancer (adenocarcinoma)
    Carcinoma del pancreas (adenocarcinoma) ad uno stadio localmente avanzato, non resecabile o metastatico
    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 10033610
    E.1.2Term Pancreatic carcinoma metastatic
    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
    Safety: Serious Adverse Events, Adverse Events leading to premature withdrawal, unexpected Tarceva related AEs and Tarceva related rash.
    Tollerabilita`: Eventi Avversi Seri, Eventi Avversi che conducono a interruzione prematura, Eventi Avversi inattesi correlati a Tarceva e rash correlato all uso di Tarceva.
    E.2.2Secondary objectives of the trial
    - Quality of life; - Efficacy of Tarceva as measured by Overall Survival and Progression Free Survival (PFS).
    - Qualita` della vita;- Efficacia di Tarceva tramite valutazione della Sopravvivenza e della Sopravvivenza libera da progressione (PFS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically confirmed pancreatic cancer (adenocarcinoma), with measurable or non measurable locally advanced, unresectable (stage III) or metastatic pancreatic cancer (stage IV) disease (according to TNM 6th edition). - No prior systemic treatment for metastatic pancreatic cancer is allowed. Radiotherapy (adjuvant setting with &#8804; 350 mg/m2/week gemcitabine) is allowed if progressive lesion(s) present outside the irradiated port. All adjuvant therapy will have been given at least 6 months prior to study entry and patients must have fully recovered from their adjuvant therapy toxicity. - Age &#8805; 18 years - ECOG performance status of 0 - 3 - Life expectancy of at least 12 weeks - Granulocyte count > 1.5 x 109/L and platelet count > 100 x 109/L - Serum (total) bilirubin &#8804; 1.5 x ULN, AST & ALT &#8804; 2.5 x ULN ( &#8804; 5 x ULN in patients with liver metastases) - Alk Phos &#8804; 2.5 ULN. If Alk Phos is &#8805; 2.5 ULN, SGOT (AST) and SGPT (ALT) must be &#8804; 1.5 ULN (or <5 ULN in case of liver metastases). - Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min - Able to comply with study and follow-up procedures - For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy. - Patients with reproductive potential must use effective contraception - Written (signed) Informed Consent to participate in the study.
    - Carcinoma del pancreas con diagnosi documentata dal punto di vista istologico o citologico (adenocarcinoma), ad uno stadio localmente avanzato, non resecabile (stadio III) o in metastasi (stadio IV), con lesioni misurabili o non misurabili (secondo la classificazione TNM 6a edizione). - Non potranno essere arruolati pazienti trattati in precedenza con terapie sistemiche per carcinoma del pancreas metastatico. La radioterapia (adiuvante in associazione con gemcitabina ad una dose &#8804; 350 mg/m2/settimana) e` consentita se la(e) lesione(i) in progressione e` (sono) localizzata(e) fuori dalla zona irradiata. Tutte le terapie adiuvanti dovranno essere state somministrate almeno 6 mesi prima dell ingresso nello studio e i pazienti dovranno essersi completamente ristabiliti dagli effetti tossici della terapia. - Eta` &#8805; 18 anni - ECOG 0 - 3 - Aspettativa di vita di almeno 12 settimane - Granulociti &gt; 1.5 x 109/L piastrine &gt; 100 x 109/L - Bilirubina sierica (totale) &#8804; 1.5 x il limite superiore di normalita` (ULN), AST & ALT &#8804; 2.5 x ULN ( &#8804; 5 x ULN in pazienti con metastasi epatiche) - Fosfatasi Alcalina &#8804; 2.5 ULN. Se la fosfatasi alcalina e` &#8805; 2.5 ULN, SGOT (AST) e SGPT (ALT) devono essere &#8804; 1.5 ULN (o &lt;5 ULN in caso di metastasi epatiche). - Creatinina sierica &lt; 1.5 ULN o clearance della creatinina &gt; 60 ml/min - Complianti verso lo studio e verso le procedure di follow-up - Per tutte le pazienti di sesso femminile potenzialmente fertili dovra` essere ottenuto un test di gravidanza negativo entro 72 ore dall inizio della terapia. - I pazienti potenzialmente fertili devono adottare metodi contraccettivi efficaci - Consenso Informato scritto a partecipare allo studio.
    E.4Principal exclusion criteria
    - Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease). - Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy). - Any other malignancies within 5 years that to the clinician s opinion may affect therapy outcome results - Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. - Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease. - Nursing mothers.
    - Malattie sistemiche instabili (comprese infezioni in fase attiva, ipertensione di grado 4, angina instabile, insufficienza cardiaca congestizia, patologie epatiche, renali o metaboliche ). - Precedente terapia sistemica antitumorale con inibitori HER1/EGFR (come terapia con molecole a basso peso molecolare e terapia con anticorpi monoclonali). - Altri tumori maligni nei 5 anni precedenti che, secondo l`opinione dello Sperimentatore potrebbero compromettere l`esito della terapia - Qualsiasi anomalia significativa a livello oftalmologico, in particolare sindrome da secchezza oculare grave, cheratocongiuntivite secca, syndrome di Sjögren, grave cheratite da esposizione o qualsiasi altra patologia che possa aumentare il rischio di lesioni epiteliali a livello della cornea. - Pazienti che non possano assumere trattamenti per via orale, che necessitino di alimentazione per via parenterale, che si siano sottoposti in precedenza a interventi chirurgici che abbiano interessato l`assorbimento, oppure che presentino ulcera peptica in fase attiva. - Pazienti di sesso femminile in allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    Safety; efficacy; quality of life.
    Tollerabilita`; efficacia; qualita` della vita.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    studio di accesso allargato, in aperto
    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.8.2.4Number of treatment arms in the trial1
    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 concerned14
    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
    Lo studio terminera` dopo che ogni paziente vivente abbia avuto un follow-up di almeno 6 mesi dopo aver interrotto Tarceva, o quando tutti i pazienti saranno morti.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned 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.1.1.2Preterm 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 state80
    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 Decision2006-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-27
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