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    Summary
    EudraCT Number:2012-004223-20
    Sponsor's Protocol Code Number:ALRAD
    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:2012-09-28
    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 number2012-004223-20
    A.3Full title of the trial
    WEEKLY PEMETREXED (ALIMTA®) AND RADIOTHERAPY IN LOCALLY ADVANCED OR LOCALLY RELAPSED NON-SQUAMOUS NON SMALL CELL LUNG CANCERS (NSCLC)
    Pemetrexed settimanale e Radioterapia nel Tumore del Polmone ad istologia non-squamosa localmente avanzata o recidivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ALIMTA AND RADIATION THERAPY IN LUNG CANCER
    ALIMTA E RADIOTERAPIA NEL TUMORE DEL POLMONE
    A.4.1Sponsor's protocol code numberALRAD
    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 SponsorUNIVERSITA' CAMPUS BIOMEDICO
    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 supportUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.5.2Functional name of contact pointUNITA' OPERATIVA DI RADIOTERAPIA
    B.5.3 Address:
    B.5.3.1Street AddressVIA EMILIO LONGONI 47
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00155
    B.5.3.4CountryItaly
    B.5.4Telephone number0622541420
    B.5.5Fax number0622541433
    B.5.6E-maill.trodella@unicampus.it
    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 ALIMTA*1FL POLV 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY ITALIA SpA
    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.3.4Pharmaceutical form Powder 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.3.9.1CAS number 137281-23-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 200
    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 NSCLC CANCER
    TUMORE DEL POLMONE NON SMALL CELL LOCALMENTE AVVANZATO O METASTATICO
    E.1.1.1Medical condition in easily understood language
    LOCALLY ADVANCED LUNG CANCER
    TUMORE DEL POLMONE IN STADIO AVANZATO
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study primary endpoint is to determine the MTD of weekly pemetrexed in combination to radiotherapy in NSCLC non-squamous patients in inoperable IIIA, IIIB stage and intrathoracic relapse pre-treated with chemotherapy.
     Determinazione della MTD del pemetrexed settimanale in concomitanza al trattamento radioterapico nel NSCLC localmente avanzato pretrattato con chemioterapia a base di platino (stage III e recidive mediastiniche)
    E.2.2Secondary objectives of the trial
    • response rate to the integrated treatment as measured by RECIST
    • nature and degree of toxicity
    • local control
     Tasso di risposta del trattamento combinato secondo i criteri RECIST
     Tipologia e grado di tossicità
     Controllo locale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histological or cytological diagnosis of non-squamous NSCLC.
    • Inoperable neoplasia: inoperable IIIA, IIIB stages and intrathoracic relapse.
    • Induction platinum-based chemotherapy (3-5 cycles).
    • No previous radiotherapy treatment.
    • ECOG Performance Status 0-1.
    • Clinically measurable or evaluable disease.
    • At least 12 weeks life expectancy.
    • Adequate respiratory function: FEV1 > 1200 cc or > 45% of theoretical value; DLCO > 40% of theoretical value
    • Cardio-vascular diseases which do not contraindicate the treatment.
    • Adequate bone marrow function: WBC  4.0 × 103/L, ANC  2.0 × 109/L, PLT  100 × 109/L, Hgb  11 g/dl, Ht  32.
    • Creatinine clearance  45 ml/min (based on the Cockcroft and Gault formula)
    • Male or female 18 to 75 years old.
    • Informed written consent.
    1. Diagnosi istologia o citologica di NSCLC non-squamoso in Stadio IIIA, IIIB o recidive secondo la classificazione UICC (in assenza di coinvolgimento della pleura e del pericardio);
    2. Chemioterapia di induzione a base di Platino;
    3. Terapia locoregionale a finalità radicale: chemioterapia con Pemetrexed settimanale (dose finding) concomitante a radioterapia;
    4. Firma del consenso informato studio – specifico.
    E.4Principal exclusion criteria
    • Inadequate hepatic function (bilirubin > 1.5 times ULN); abnormal PT, aPTT (upper than 1.5 times control values); ALT and AST > 3 times ULN
    • Inadequate renal function (serum creatinine > 1.5 times ULN and Creatinine Clearance: < 45 ml/min
    • Patients who are:
    - pregnant or lactating;
    - at risk of pregnancy during the study. This must be checked by pregnancy test at study entry. The patient must be receiving a medically accepted contraceptive regimen
    • Breast-feeding
    • Concurrent systemic disorders incompatible with chemotherapy
    • History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
    • Pa02  65 mmHg; PaCO2 > 40 mmHg
    • Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents 2 days before the day of, and 2 days after the dose of pemetrexed. If a patient is taking an NSAID (COX-2 inhibitors included) or salicylate with a long half-life (for example, naproxen, piroxicam, diflunisal, nabumetone, rofecoxib or celecoxib) it should not be taken 5 days before the dose of pemetrexed (8-day period for long-acting agents such as piroxicam), the day of, and 2 days after the dose of pemetrexed.
    • Clinically significant effusions for patients who develop or have baseline clinically significant pleural or peritoneal effusions ( on the basis of symptoms or clinical examination) before or during initiation of pemetrexed therapy, consideration should be given draining the effusion prior to dosing. However if, in the investigator's opinion, the effusion represents progression of disease, the patients should be discontinued from the study.
    • Inadequate hepatic function (bilirubin > 1.5 times ULN); abnormal PT, aPTT (upper than 1.5 times control values); ALT and AST > 3 times ULN
    • Inadequate renal function (serum creatinine > 1.5 times ULN and Creatinine Clearance: < 45 ml/min
    • Patients who are:
    - pregnant or lactating;
    - at risk of pregnancy during the study. This must be checked by pregnancy test at study entry. The patient must be receiving a medically accepted contraceptive regimen
    • Breast-feeding
    • Concurrent systemic disorders incompatible with chemotherapy
    • History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
    • Pa02  65 mmHg; PaCO2 > 40 mmHg
    • Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents 2 days before the day of, and 2 days after the dose of pemetrexed. If a patient is taking an NSAID (COX-2 inhibitors included) or salicylate with a long half-life (for example, naproxen, piroxicam, diflunisal, nabumetone, rofecoxib or celecoxib) it should not be taken 5 days before the dose of pemetrexed (8-day period for long-acting agents such as piroxicam), the day of, and 2 days after the dose of pemetrexed.
    • Clinically significant effusions for patients who develop or have baseline clinically significant pleural or peritoneal effusions ( on the basis of symptoms or clinical examination) before or during initiation of pemetrexed therapy, consideration should be given draining the effusion prior to dosing. However if, in the investigator's opinion, the effusion represents progression of disease, the patients should be discontinued from the study.
    • funzionalità epatica inadeguata (bilirubina&gt; 1,5 volte ULN), anormale PT, aPTT (superiore di 1,5 volte il valore di controllo), ALT e AST&gt; 3 volte ULN
    • Funzione inadeguata renale (creatinina sierica&gt; 1,5 volte ULN e Clearance della creatinina: &lt;45 ml / min
    • I pazienti che sono:
    - Stato di gravidanza o in allattamento;
    - A rischio di gravidanza durante lo studio. Questo deve essere controllato da test di gravidanza all'inizio dello studio. Il paziente deve essere in trattamento con un medico accettato contraccettivo
    • L'allattamento al seno
    • disturbi concomitanti sistemiche incompatibili con la chemioterapia
    • Storia di un altro tumore maligno negli ultimi cinque anni successivi carcinoma delle cellule basali della pelle o carcinoma in situ della cervice
    • PA02  65 mmHg, PaCO2&gt; 40 mmHg
    • Giorni Impossibilità di interrompere l'aspirina o altri non-steroidei anti-infiammatori agenti 2 giorni prima del giorno di, e 2 dopo la dose di pemetrexed. Se un paziente sta assumendo un FANS (COX-2 inibitori incluso) o salicilato con una lunga emivita (per esempio, naproxene, piroxicam, diflunisal, nabumetone, rofecoxib o celecoxib) non dovrebbe essere presa 5 giorni prima della dose di pemetrexed (8 giorni di lunga durata d'azione per agenti come piroxicam), il giorno stesso e nei 2 giorni dopo la dose di pemetrexed.
    • versamenti clinicamente significative per i pazienti che sviluppano o hanno basali versamento clinicamente significativi pleurico o peritoneale (sulla base di sintomi o l'esame clinico) prima o durante l'inizio della terapia con pemetrexed, occorre tenere in considerazione drenare il versamento prima del trattamento. Tuttavia, se, a giudizio dello sperimentatore, l'effusione rappresenta progressione della malattia, i pazienti devono essere interrotto dallo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Study primary endpoint is to determine the MTD of weekly pemetrexed in combination to radiotherapy in NSCLC non-squamous patients in inoperable IIIA, IIIB stage and intrathoracic relapse pre-treated with chemotherapy.
    Determinazione della MTD del pemetrexed settimanale in concomitanza al trattamento radioterapico nel NSCLC localmente avanzato pretrattato con chemioterapia a base di platino (stage III e recidive mediastiniche)
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 MONTHS
    18 MESI
    E.5.2Secondary end point(s)
    • response rate to the integrated treatment as measured by RECIST
    • nature and degree of toxicity
    • local control
     Tasso di risposta del trattamento combinato secondo i criteri RECIST
     Tipologia e grado di tossicità
     Controllo locale
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 MONTHS
    18 MESI
    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 Yes
    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 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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    LVLS
    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 months36
    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.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    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)
    NORMAL CLINICAL PRACTICE
    NORMALE PRASSI CLINICA, FOLLOW UP ONCOLOGICO
    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 Decision2012-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-25
    P. End of Trial
    P.End of Trial StatusOngoing
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