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    Summary
    EudraCT Number:2009-017270-21
    Sponsor's Protocol Code Number:TCD11420
    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:2010-03-19
    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 number2009-017270-21
    A.3Full title of the trial
    Randomized phase 2 study of gemcitabine/cisplatin with or without SAR240550 (BSI-201), a PARP1 inhibitor, in patients with stage IV non-small cell lung cancer
    Studio di fase 2 randomizzato con gemcitabina/cisplatino somministrati da soli o in combinazione a SAR240550 (BSI-201), un PARP-1inibitore, in pazienti affetti da carcinoma polmonare non a piccole cellule in stadio IV.
    A.4.1Sponsor's protocol code numberTCD11420
    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 Sponsorsanofi-aventis recherche & de'veloppement
    B.1.3.4CountryFrance
    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 No
    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.3.2Product code SAR240550 (BSI-201)
    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 INNOTHER ANTINEOPLASTIC AGENTS
    D.3.9.2Current sponsor codeSAR240550 (BSI-201)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.2.1.2Country 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 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 INNGemcitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number38
    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: 3
    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.2.1.2Country 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 solution for injection
    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 INNCisplatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number1
    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
    Non-small cell lung cancer stage IV
    carcinoma polmonare non a piccole cellule in stadio IV
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    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
    Primary objective is to assess the objective response rate (ORR) of SAR240550 administered as a 60-min intravenous infusion twice weekly, when combined to gemcitabine/cisplatin chemotherapy regimen (GCS) as well as with the standard regimen of gemcitabin/cisplatin (GC) in patients with stage IV non small cell lung cancer
    Valutare la percentuale di risposte obiettive (ORR) con SAR240550 somministrato per infusione endovenosa di 60 minuti secondo uno schema bi-settimanale, quando somministrato in combinazione ad un regime chemioterapico a base di gemcitabina/cisplatino (GCS) in pazienti affetti da carcinoma polmonare non a piccole cellule (NSCLC) in stadio IV.
    E.2.2Secondary objectives of the trial
    To assess the safety profiles of the study combination gemcitabine/cisplatin/SAR240550 (GCS) and of the standard regimen gemcitabine/cisplatin (GC) alone - To assess the progression free survival and the overall survival in both arms. - To assess the relationship between DNA repair pathway characteristics of tumors at baseline and clinical outcome of disease. - To assess the effect of SAR240550 on PAR level in peripheral blood mononuclear cells (PBMC).
    -Valutare il profilo di tollerabilita' della combinazione di studio GCS e del trattamento standard solo con GC. -Valutare la sopravvivenza libera da progressione (PFS) e la sopravvivenza globale (OS) in entrambi i bracci di trattamento -Valutare la correlazione tra le caratteristiche della via di riparazione del DNA dei tumori al basale e l esito clinico della malattia. -Valutare l effetto di SAR240550 sul livello di PAR nelle cellule mononucleate del sangue periferico (PBMC).
    E.2.3Trial contains a sub-study Yes
    E.3Principal inclusion criteria
    Stage IV disease (including stage IIIB with pleural effusion) with no prior systemic therapy. Adjuvant therapy is allowed if ended more than 1 year before inclusion in the study. - Histologically confirmed squamous cell bronchogenic carcinoma OR non squamous cell carcinoma. - Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the selected measurable lesions are outside the original radiation therapy port. Radiation therapy must have been completed >4 weeks prior to study entry. - Palliative radiotherapy must have been completed > 2 weeks prior to study entry. Irradiated lesions may not serve as measurable lesions. - At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. - Adequate bone marrow reserve. - Adequate liver and renal function. - Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during 6 months after the last study treatment administration.
    I 01. Neoplasia allo stadio IV di malattia (in base ai criteri aggiornati UICC) senza precedente terapia sistemica. La terapia adiuvante e` consentita se terminata piu` di 1 anno prima dall’inclusione nello studio. I 02. Carcinoma broncogenico a cellule squamose NSCLC o carcinoma NSCLC a cellule non squamose, confermati istologicamente. I 03. Pazienti sottoposti in precedenza a radioterapia (definita come terapia definitiva per carcinoma polmonare non a piccole cellule localmente avanzato), sono eleggibili, a condizione che le lesioni misurabili selezionate siano fuori dall’area originaria di radioterapia. La radioterapia deve essere stata completata piu` di 4 settimane prima dell’arruolamento nello studio. I03-A2 La radioterapia palliativa deve essere stata completata piu` di 2 settimane prima dell’arruolamento nello studio. Le lesioni irradiate non possono essere considerate come lesioni misurabili. I 04. Almeno una lesione misurabile in base ai criteri RECIST 1.1 I 05. ECOG performance status pari a 0 -1. I 06. Seguenti valori di laboratorio:  Conta assoluta dei neutrofili (ANC) ≥1500/l e piastrine ≥100.000/l (≤ 7 giorni precedenti l’inizio della terapia).  Emoglobina ≥ 9 g/dl (i pazienti possono essere trasfusi o ricevere eritropoietina per mantenere o aumentare questo livello).  Bilirubina ≤1,0 volte il limite superiore di normalita` (o bilirubina &lt; 1,5 volte il limite superiore di normalita` in caso di sindrome di Gilbert, a condizione che ALT/AST siano ≤1,5 volte il limite superiore di normalita`).  Alanina aminotransferasi (ALT) e aspartato aminotransferasi (AST) ≤2,5 volte il limite superiore di normalita` in assenza di coinvolgimento epatico o ≤5 volte il limite superiore di normalita` in caso di coinvolgimento epatico.  Clearance della creatinina ≥60 ml/min. I 07. Per le donne in eta` fertile, test di gravidanza negativo eseguito entro i 7 giorni precedenti l’ingresso nello studio. Le donne e gli uomini in eta` fertile e i loro partner devono seguire un metodo di controllo delle nascite adeguato durante il corso della terapia in studio e durante i 6 mesi successivi all’ultima somministrazione del trattamento in studio. Se una donna rimanesse incinta o sospettasse di esserlo durante la partecipazione allo studio, deve acconsentire ad informare immediatamente il medico dello studio. I 08. eta` ≥18 anni. I 09. Capacita` di comprendere e aderire a quanto descritto nel protocollo. I 10. Consenso(i) informato(i) scritto(i).
    E.4Principal exclusion criteria
    Prior treatment with gemcitabine, platinum salts or any PARP inhibitor class compound. - Past or current history of neoplasm other than the entry diagnosis, with the exception of treated non-melanoma skin cancer or carcinoma in-situ of the cervix, or other cancers cured by local therapy alone and with an expected disease-free survival of ≥5 years. - Major medical conditions that might affect study participation e.g. cardiac disease, uncontrolled infection (>Grade 2). - Presence of active brain metastases. - A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study. - Any history of medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results - Grade 2 or higher ear and labyrinth disorders. - Known or suspected allergy/hypersensitivity to any agent given in the course of this trial
    1.Precedente terapia con gemcitabina, sali di platino o qualsiasi farmaco appartenente alla classe dei PARP inibitori. 2.Anamnesi di neoplasie in altre sedi rispetto a quella della diagnosi, ad eccezione di neoplasie cutanee diverse dal melanoma adeguatamente trattato e dal carcinoma in situ della cervice, o di altre patologie tumorali con un intervallo libero da malattia atteso superiore a 5 anni. 3.Patologie importanti che possano pregiudicare la partecipazione allo studio come malattie cardiache o infezioni non controllate (grado &gt;2). 4.Presenza di metastasi cerebrali in fase attiva. 5.Intervento chirurgico maggiore, incluse biopsie a cielo aperto o ferite traumatiche significative nei 28 giorni precedenti l inizio del trattamento, o intervento chirurgico maggiore pianificato nel corso dello studio. 6.Qualsiasi condizione clinica o psichiatrica o alterazioni dei valori di laboratorio che secondo l opinione dello sperimentatore, possa aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del prodotto sperimentale o che possa interferire con l interpretazione dei risultati. 7.Disturbi uditivi o vestibolari di grado 2 o superiore. 8.Nota o sospetta allergia o ipersensibilita' a qualsiasi sostanza somministrata nel corso di questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR) that is defined in the RECIST 1.1 version, as: complete response rate + partial response rate.
    L endpoint primario di efficacia e' l ORR che e' definita, nella versione dei RECIST 1.1, come: percentuale di risposta completa (CR) + percentuale di risposta parziale (PR).
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunoistochimica dei biomarker tumorali
    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 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) Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    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 months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    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.1.1Number 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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 105
    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 Decision2010-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-12
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