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    Summary
    EudraCT Number:2017-005108-89
    Sponsor's Protocol Code Number:VHIO17002
    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:2021-10-18
    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 number2017-005108-89
    A.3Full title of the trial
    Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumors.
    Studio “Basket of Baskets” multicentrico, modulare, in aperto, di fase II per valutare agenti mirati in popolazioni selezionate a livello molecolare con tumori solidi avanzati.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A modular multi-Basket trial to improve personalized medicine in cancer patients
    Studio modulare atto a migliorare la medicina personalizzata nei pazienti oncologici
    A.3.2Name or abbreviated title of the trial where available
    Basket of Baskets
    Basket of Baskets
    A.4.1Sponsor's protocol code numberVHIO17002
    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 SponsorVALL D'HEBRON INSTITUTE OF ONCOLOGY (VHIO)
    B.1.3.4CountrySpain
    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 supportTaiho Oncology Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportF.Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVall d'Hebron Institute of Oncology (VHIO)
    B.5.2Functional name of contact pointSusana Munoz
    B.5.3 Address:
    B.5.3.1Street AddressCellex Building; Carrer Natzaret, 115-117
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number+349325434508614
    B.5.5Fax number+349325434508614
    B.5.6E-mailsmunoz@vhio.net
    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.3.1Product nameFutibatinib
    D.3.2Product code [TAS-120]
    D.3.4Pharmaceutical form 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 INNFUTIBATINIB
    D.3.9.1CAS number 1448169-71-8
    D.3.9.2Current sponsor codeTAS-120
    D.3.9.4EV Substance CodeSUB130443
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Limited
    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.3.1Product nameTecentriq
    D.3.2Product code [Tecentriq]
    D.3.4Pharmaceutical form Concentrate and solvent for concentrate 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 INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameAtezolizumab (MPDL3280A) is a human immunoglobulin (Ig) G1 monoclonal antibody that targets programmed death-1 ligand-1 (PD-L1) and inhibits its interaction with programmed cell death 1 (PD-1) receptor. The antibody consists of two heavy chains (448 amino acid residues each) and two light chains (214 amino acid residues each) and is produced in Chinese hamster ovary (CHO) cells.
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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
    Subjects with advanced solid tumour
    Soggetti con tumore solido avanzato
    E.1.1.1Medical condition in easily understood language
    Cancer
    Cancro
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    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
    The primary objective is to evaluate the antitumour activity of each
    matched therapy in small subject populations as a signal finding study.
    L'obiettivo primario è quello di valutare l'attività antitumorale di ciascuna terapia abbinata in piccole popolazioni di soggetti come studio di ricerca del segnale.
    E.2.2Secondary objectives of the trial
    • To determine the prevalence of genetic alteration in the iPROFILER
    screened population.
    • To evaluate the clinical benefit of matching therapies in small patient
    populations.
    • To evaluate the safety and tolerability of each investigational agent
    tested as assessed by the incidence and severity of adverse events.
    • Determinare la prevalenza dell'alterazione genetica nella popolazione iPROFILER sottoposta a screening.
    • Valutare il beneficio clinico delle terapie abbinate in piccole popolazioni di pazienti.
    • Valutare la sicurezza e la tollerabilità di ciascun agente sperimentale testato valutato dall'incidenza e dalla gravità degli eventi avversi.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Radiomics sub-study (Module 1 specific):
    • The primary objective of this sub-study is to evaluate CT-radiomics
    signature of solid tumours that predicts response to atezolizumab.
    • The secondary objectives are to evaluate early changes in CTradiomics
    signatures as response to atezolizumab, to evaluate
    correlation of radiomics features with tumour mutational status to
    develop radiogenomics phenotypes, and to evaluate correlation of CTradiomics
    features with histological features from tumour samples.

    SIMPATHY sub-study (Module 1 specific):
    • SIMPATHY sub-study aims to produce a detailed map of the tumour
    immune microenvironment before, during and after failure of ICI
    treatment with the anti-PDL1 monoclonal atezolizumab, contextualized
    with genomic and systemic immune features.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio di radiomica (specifico del Modulo 1):
    • L'obiettivo principale di questo sottostudio è valutare la radiomica di TAC di tumori solidi per predire la risposta ad atezolizumab.
    • Gli obiettivi secondari sono valutare i cambiamenti precoci nella radiomica di TAC in risposta ad atezolizumab, per valutare la correlazione delle caratteristiche radiomiche con lo stato mutazionale del tumore a sviluppare fenotipi di radiogenomica e valutare la correlazione di TAC radiomiche con caratteristiche istologiche da campioni tumorali.

    Sottostudio SIMPATHY (Specifico del Modulo 1):
    • Il sottostudio SIMPATHY mira a produrre una mappa dettagliata del microambiente immunitario tumorale prima, durante e dopo il fallimento di ICI trattamento con l'anticorpo monoclonale anti-PDL1 atezolizumab, contestualizzandolo con caratteristiche immunitarie genomiche e sistemiche.
    E.3Principal inclusion criteria
    Part A:
    1. Subjects must have histologically/cytologically confirmed malignancy that is metastatic/unresectable, who have progressed to standard therapy, receiving a standard anticancer treatment but no subsequent approved treatment would be available upon progression, unable to receive standard therapy, or for whom standard
    therapy does not exist.
    2. Subjects must have ECOG performance status of 0 or 1.
    3. must be 18 year-old or older.
    4. must have measurable disease according to RECIST 1.1.
    5. must have enough tumour tissue for molecular analysis
    • Subjects providing formalin-fixed paraffin embedded tissue (FFPE) must provide 20-28 sample. If there is not enough archival tissue, the subject must undergo a tumour biopsy.
    • Subjects providing fresh frozen tissue (FFT) must provide 4 biopsies . FFT must be collected from a tumour biopsy; hence, patients must have disease amenable to be biopsied. Otherwise, the subject should have FFT stored in a biobank/biorepository.
    • Efforts will be made to provide FFT in 1/4 of the participating subjects. The proportion of subjects that might provide FFT might change based on the results from the molecular analysis.
    • Since some of the tests are performed in FFPE tissue, patients providing FFT from a recent biopsy will have part of the sample processed in FFPE tissue as per Laboratory manual.
    6. Subjects must have adequate hematological function: absolute granulocyte count = 1.5 × 10 9/L, platelet count = 100 × 10 9/L.
    7. Subject must have adequate renal and hepatic function: Serum creatinine = 1.5 × ULN and creatinine clearance = 30ml/min, serum bilirubin = 1.5 × ULN; unless due to Gilbert's syndrome, AST/ALT = 5 × ULN if liver metastases are present or AST/ALT = 3 × ULN if the subject has no liver involvement.
    8. For subjects requiring a tumour biopsy: patients must have adequate coagulation function quick time = 60% or INR = 1.5
    9. Subjects must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumour
    10. Ability to understand and the willingness to sign a written informed consent document.
    Part B:
    Inclusion criterion 2/3/4/6/8/9/10/12 from part A
    1. Subjects must have metastatic or unresectable malignant tumour, histologically or cytological confirmed and progressing to current therapy. Tumours must be refractory to standard therapy or tumours for which standard therapy does not exist, or subjects may be unable to receive standard therapy.
    2. Subjects must have adequate renal and hepatic function:
    • Serum creatinine = 1.5 × ULN or creatinine clearance = 30 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation:
    (140 - age) × (weight in kg) × (0.85 if female)/72 × (serum creatinine in mg/dL)
    • Serum bilirubin = 1.5 × ULN; with the following exception: subjects with known Gilbert disease who have serum bilirubin level = 3 × ULN may be enrolled
    •AST, ALT, and alkaline phosphatase < 2.5 x ULN, with the following exceptions:
    oPatients with documented liver metastases: AST and ALT < 5 x ULN
    oPatients with documented liver or bone metastases: alkaline phosphatase < 5 x ULN
    3. Subjects receiving therapeutic anticoagulation (such as low- molecular weight heparin or warfarin) should be on a stable dose
    4.For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year (when used consistently and correctly) during the treatment period and for at least 5 months after the last dose of atezolizumab/ 6 months after the last dose of
    Futibatinib, in case of being included in Part B of the study. Please see protocol for more details.
    5.For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined in the protocol (Please refer to section 3.1 Inclusion Criteria of iProfiler, Module 1 and 2 for full list)
    Parte A:
    1. I soggetti devono avere un tumore maligno confermato istologicamente/citologicamente metastatico/non resecabile, passati alla terapia standard, che stanno ricevendo un trattamento antitumorale standard ma nessun trattamento successivo approvato sarebbe disponibile, non in grado di ricevere una terapia standard, o per chi non ha terapia standard
    2. I soggetti devono avere: un performance status ECOG pari a 0 o 1.
    3. " almeno 18 anni.
    4. " una malattia misurabile secondo RECIST 1.1.
    5. " tessuto tumorale sufficiente per l'analisi molecolare
    • I soggetti che forniscono tessuto incluso in paraffina fissato in formalina (FFPE) devono fornire tra 20 e 28 vetrini a seconda del campione. Altrimenti,il soggetto deve sottoporsi biopsia.
    • I soggetti che forniscono tessuto fresco congelato (FFT) devono fornire 4 biopsie. La FFT deve essere prelevata da biopsia tumorale; i pazienti devono avere malattia sottoponibile a biopsia. Altrimenti, il soggetto dovrebbe avere FFT in una biobanca/biorepository.
    • Si cercherà di fornire FFT in 1/4 dei soggetti partecipanti. La proporzione potrebbe cambiare in base ai risultati dell'analisi molecolare.
    • Poiché alcuni dei test vengono eseguiti in tessuto FFPE, i pazienti che forniscono FFT avranno una parte del campione processata in tessuto FFPE come da manuale di laboratorio.
    6. I soggetti devono avere: una funzionalità ematologica adeguata: conta assoluta dei granulociti = 1,5 × 10 9/L, conta piastrinica = 100 × 10 9/L.
    7. " renale ed epatica: creatinina sierica = 1,5 × ULN e clearance della creatinina = 30 ml/min, bilirubina sierica = 1,5 × ULN; a meno che non sia dovuto alla sindrome di Gilbert, AST/ALT = 5 × ULN se sono presenti metastasi epatiche o AST/ALT = 3 × ULN se il soggetto non ha coinvolgimento epatico.
    8. Per i soggetti che richiedono una biopsia tumorale: i pazienti devono avere un'adeguata funzione coagulativa quick time = 60% o INR = 1,5
    9. " essere disposti a partecipare a una sperimentazione clinica con una terapia abbinata in base al profilo molecolare del tumore
    10. Capacità di comprensione e disponibilità a firmare consenso informato scritto.
    Parte B:
    Criterio di inclusione 2/3/4/6/8/9/10/12 dalla parte A
    1. I soggetti devono avere un tumore maligno metastatico/non resecabile, confermato isto/citologicamente e in progressione alla terapia attuale. I tumori devono essere refrattari alla t. standard o tumori per i quali non esiste t.standard, o soggetti potrebbero non essere in grado di ricevere t.standard.
    2. I soggetti devono avere un'adeguata funzionalità renale ed epatica: Creatinina sierica = 1,5 × ULN o clearance della creatinina = 30 mL/min sulla base della stima della velocità di filtrazione glomerulare di Cockcroft-Gault:(140 - età) × (peso in kg) × (0,85 se femmina)/72 × (creatinina sierica in mg/dL)
    Bilirubina sierica = 1,5 × ULN; con la seguente eccezione: possono essere arruolati soggetti con malattia di Gilbert nota che hanno un livello di bilirubina sierica = 3 × ULN
    AST, ALT e fosfatasi alcalina < 2,5 x ULN, con le seguenti eccezioni:
    Pazienti con metastasi epatiche documentate: AST e ALT < 5 x ULN
    Pazienti con metastasi epatiche o ossee documentate: fosfatasi alcalina < 5 x ULN
    3. I soggetti che ricevono anticoagulanti terapeutici (eparina/warfarin) devono assumere una dose stabile
    4.Per le donne in età fertile: accordo ad astenersi (da rapporti eterosessuali) o usare contraccettivi con un tasso di fallimento di <1% all'anno (se usati in modo corretto) durante il periodo di trattamento e per almeno 5 mesi dopo l'ultima dose di atezolizumab/ 6 mesi dopo l'ultima dose di Futibatinib, in caso di inclusione nella Parte B dello studio. Si prega di consultare il protocollo per maggiori dettagli.
    5.Per gli uomini: accordo ad astenersi (da rapporti eterosessuali) o utilizzare misure contraccettive e astenersi dal donare sperma, come definito nel protocollo (fare riferimento alla sezione 3.1 Criteri di inclusione di iProfiler, Modulo 1 e 2 per elenco)
    E.4Principal exclusion criteria
    Part A
    1.Subjects with leptomeningeal disease should be excluded
    2.Subjects with known unstable brain metastases should be excluded
    •Exception: Subjects who have undergone surgery and/or radiotherapy and in which brain metastases are stable or decrease for 6 months after completed therapy.
    3.Subjects with spinal cord compression not def treated with surgery and/or radiation.
    4.Subjects with uncontrolled intercurrent illness includ, but not limited to, active infection, symptomatic congestive heart failure, LVEF < 50%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    5.Subjects with inability to swallow tablets or capsules.
    6.Subjects with known HIV, hepatitis B/C .
    7.Subjects with known history of malabsorption.
    Part B:
    1.Pregnant or breastfeeding women. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to Day1. This negative test will be valid for Cycle 1 day 1. In subseq. cycles, test will be performed on day 1 of each cycle, with a +/- 3 day window, and prior to drug admin.
    2.Any approved anticancer therapy, including chemo, hormonal or radiotherapy, within 3 weeks prior to initiation of study treatment; the following are allowed:
    •Hormone-replacement therapy or oral contraceptives.
    •Somatostatin analogues for the treatment of neuroendocrine tumours.
    •Gonadotropin-releasing hormone agonists or antiandrogens for prostate cancer.
    •Palliative radiotherapy for bone metastases > 2 weeks prior to Cycle 1, Day 1.
    3.Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticip of need for a major surgical proced during the course of the study.
    4.Treatment with an IA within 4 weeks prior to Cycle 1, Day 1 (or within five half-lives of the investigational product), with the exception of monoclonal antibodies. Based on the half-life of mono antibodies and the limited overlap on toxicities, a 4 week wash-out period is allowed.
    5.Subjects with known unstable brain metastases should be excluded
    •Exception: Subjects with treated brain metastasis which remain stable or resp 6 weeks after completing radio can be included. 6.Uncontrolled intercurrent illness including, but not limited to, active infection, cardiovascular disease, or psychiatric illness/social situations that would limit compliance with study requirements.
    7.Subjects with active hepatitis B (positive hepatitis B surface antigen at screening) hep C.
    •Subjects with past hepatitis B or resolved HBV (negative HBsAg test and a positive Ab to hepatitis B test) are eligible.
    •Subjects positive for hepatitis C antibody are eligible only if PCR is negative for HCV RNA.
    8.Significant cardiovascular disease, such as NY Heart Assoc cardiac disease (Class II or greater), myocardial infarction within 3 months prior to Cycle 1, Day 1, unstable arrhythmias/angina.
    9.Another primary malignancy other than disease under study within 2 years prior to Cycle 1 Day 1, unless consider at low risk at PI discretion.
    10.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, fusion proteins or any excipient of the experimental product.
    11.Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
    13. Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study.
    • Influenza vaccination can be given during influenza season only (example: approximately October to March in the Northern Hemisphere), but subjects must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1 or at any time during the study.
    14. History of active tuberculosis.
    15. Contraindications included in the product information of the drugs used in the study.
    Please refer to section 3.2 Exclusion Criteria for full list of iProfiler, Module 1 and 2.
    parte A
    1. I soggetti con malattia leptomeningea devono essere esclusi
    2. I soggetti con metastasi cerebrali instabili note devono essere esclusi
    •Eccezione: soggetti che hanno subito un intervento chirurgico/radioterapia e le metastasi rimangono stabili o diminuiscono nei 6 mesi succ.
    3.Soggetti con compressione midollare non trattati def. con chirurgia e/o radiazioni.
    4.Soggetti con malattie intercorrenti incontrollate, ad es infezione attiva, insufficienza cardiaca congestizia sintomatica, FEVS < 50%, angina pectoris instabile, aritmia cardiaca malattie psichiatriche/sociali che limiterebbero la conformità ai requisiti
    5.Soggetti con incapacità di deglutire compresse
    6."con infezione nota da HIV, epatite B/C
    7."storia nota di malassorbimento.
    Parte B:
    1. Donne incinte/che allattano. Le donne fertili devono avere un test di gravidanza sierico negativo entro 14 giorni prima del Giorno 1. Questo test negativo sarà valido per il Ciclo 1 giorno 1. Nei cicli successivi, il test sarà eseguito il giorno 1 di ogni ciclo e prima della somministrazione del farmaco.
    2.Qualsiasi terapia antitumorale approvata, compresa la chemioterapia, la terapia ormonale o la radioterapia, nelle 3 settimane precedenti l'inizio del trattamento in studio; sono consentiti:
    •Terapia ormonale sost o contraccettivi orali.
    • Analoghi della somatostatina per tumori neuroendocrini.
    •Agonisti dell'ormone di rilascio delle gonadotropine o antiandrogeni per cancro alla prostata.
    • Radioterapia palliativa per metastasi ossee > 2 settimane prima del Ciclo 1, Giorno 1.
    3.Intervento chirurgico entro 28 giorni prima del Ciclo 1, Giorno 1 o necessità di un intervento chirurgico nel corso dello studio.
    4.Trattamento con un agente in sperimentazione nelle 4 settimane precedenti il Ciclo 1, Giorno 1 (o entro cinque emivite del prodotto in sperimentazione, ad eccezione degli anticorpi monocl. Sulla base dell'emivita degli anticorpi monocl e della sovrapposizione di tossicità, sarà consentito un periodo wash-out di 4 sett.
    5.Soggetti con metastasi cerebrali instabili note devono essere esclusi
    •Eccezione: possono essere inclusi i soggetti con metastasi cerebrali trattate che rimangono stabili o risp 6 sett dopo il completamento della radioterapia. 6.Malattie intercorrenti non controllate incluse, ma non limitate a, infezioni attive, malattie cardiovascolari o malattie psichiatriche/situazioni sociali che limiterebbero la conformità ai requisiti
    7.Soggetti con epatite B attiva o epatite C.
    •Sono idonei i soggetti con pregressa infezione da virus dell'epatite B o infezione da HBV risolta
    •I soggetti positivi per l'anticorpo del virus dell'epatite C sono idonei solo se la PCR è negativa
    8. Malattie cardiovascolari significative, malattie cardiache della New York Heart Association (Classe II o sup), infarto miocardico nei 3 mesi prec il Ciclo 1, Giorno 1, aritmie o angina instabili
    9.altro tumore maligno primario diverso dalla malattia in studio entro 2 anni prima del Ciclo 1 Giorno 1, se non considerato a basso rischio di recidiva a discrezione del PI
    10.Storia di gravi reazioni allergiche, anafilattiche o ipersensibilità ad anticorpi chimerici o umanizzati, prot di fusione o eccipiente dell'IP.
    11.Precedente trapianto di midollo osseo allogenico o di organi solidi.
    13. Somministrazione di un vaccino vivo attenuato nelle 4 sett preced il Ciclo 1, Giorno 1 o anticipazione che tale vaccino vivo attenuato sarà necessario durante lo studio.
    • La vaccinazione antinfluenzale può essere somministrata solo durante la stagione influenzale (es.da ottobre a marzo nell'emisf settentr), ma i soggetti non devono ricevere il vaccino antinfluenzale vivo attenuato (ad es. FluMist®) nelle 4 sett prima del Ciclo 1, Giorno 1 o in qualsiasi momento dello studio.
    14. Storia di tubercolosi attiva.
    15. Controindicazioni incluse nelle informazioni sul prodotto dei farmaci utilizzati
    Fare riferimento alla sezione 3.2 Criteri di esclusione per l'elenco completo di iProfiler, Modulo 1 e 2.
    E.5 End points
    E.5.1Primary end point(s)
    Module 1 & 2:
    • Overall response rate (ORR) or complete response (CR) by RECIST 1.1
    of different targeted agents in molecularly selected small patient
    populations.
    No specific primary endpoint in iProfiler (Part A) protocol.
    Modulo 1 e 2:
    • Tasso di risposta globale (ORR) o risposta completa (CR) secondo RECIST 1.1 di diversi agenti mirati in piccole popolazioni di pazienti selezionati molecolarmente .
    Nessun endpoint primario specifico nel protocollo iProfiler (Parte A).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 12 (Module 1)
    At Week 16 (Module 2)
    Settimana 12 (Modulo 1)
    Settimana 16 (Modulo 2)
    E.5.2Secondary end point(s)
    Specific Secondary Endpoints for iProfiler (Part A):
    •To determine the prevalence of genetic alterations in the iPROFILER
    screened population.
    • Progression free survival (PFS by RECIST 1.1) of the patients treated
    with each investigational agent evaluated at the end of the module.
    • Progression Free Survival (PFS by RECIST 1.1) at 6 months of subjects
    treated with each investigational agent.
    • Overall survival (OS) of subjects treated with each investigational agent evaluated at the end of each module.
    • Incidence and severity of adverse events (AEs) in subjects receiving
    each investigational agent.
    Specific Secondary Endpoints for Module 2:
    • Duration of response (CR or PR), calculated from the date of initial
    documentation of a response to the date of first documented evidence of
    progressive disease (or relapse for subjects who experience CR during
    the study) or death. Data from subjects who are progression-free and
    alive or have unknown status will be censored at the last tumour
    assessment.
    Endpoint secondari specifici per iProfiler (Parte A):
    •determinare la prevalenza delle alterazioni genetiche nella popolazione iPROFILER sottoposta a screening.
    • Sopravvivenza libera da progressione (PFS secondo RECIST 1.1) dei pazienti trattati con ciascun agente sperimentale valutato alla fine del modulo.
    • Sopravvivenza libera da progressione (PFS secondo RECIST 1.1) a 6 mesi dei soggetti trattati con ciascun agente sperimentale.
    • Sopravvivenza globale (OS) dei soggetti trattati con ciascun agente sperimentale valutata alla fine di ogni modulo.
    • Incidenza e gravità degli eventi avversi (EA) nei soggetti che ricevono ciascun agente sperimentale.
    Endpoint secondari specifici per il Modulo 2:
    • Durata della risposta (CR o PR), calcolata dalla data di iniziale documentazione di una risposta alla data della prima prova documentata di
    malattia progressiva (o recidiva per i soggetti che manifestano CR durante lo studio) o la morte. Dati da soggetti che sono liberi da progressione e
    in vita o con status sconosciuto verrà censurato all'ultima valutazione tumorali.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Progression free survival at the end of the module.
    - Progression Free Survival at 6 months
    - Overall survival at the end of the module
    - Safety, continued evaluation during the trial
    - Sopravvivenza libera da progressione alla fine del modulo.
    - Sopravvivenza libera da progressione a 6 mesi
    - Sopravvivenza globale alla fine del modulo
    - Sicurezza, valutazione continua durante il trial
    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 No
    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 Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    basket of basket study, studio modulare
    basket of basket study, modular study
    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
    na
    na
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Netherlands
    Spain
    Sweden
    United Kingdom
    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
    End of the each module will be considered 6 months after the last dose
    of the last participant patient in that specific module (after the Followup
    visit) or until all subjects have died, withdrawn consent or are lost
    to follow-up (whichever occurs first). A subject will be considered lost
    to follow up when reasonable attempts are made by the site to contact
    him/her without success.
    La fine di ogni modulo sarà considerata 6 mesi dopo l'ultima dose dell'ultimo paziente partecipante a quel modulo specifico (dopo il Follow Up) o fino a quando tutti i soggetti sono morti, revocato il consenso o mancano al follow-up (a seconda di quale si verifica per primo). Un soggetto sarà considerato mancante al FUP quando verranno effettuati tutti i tentativi ragionevoli da parte del centro per contattare lui/lei senza successo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 180
    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)
    No plans for treatment after the subject has ended the participation in
    the trial.
    Nessun piano di trattamento dopo che il soggetto ha terminato la partecipazione alla sperimentazione.
    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 Decision2021-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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