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    Summary
    EudraCT Number:2018-003355-38
    Sponsor's Protocol Code Number:D0816C00025
    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:2022-04-14
    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 number2018-003355-38
    A.3Full title of the trial
    A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients with Solid Tumours
    Studio di fase I, in aperto, a gruppi paralleli volto a valutare la sicurezza, la tollerabilità, l’efficacia e la farmacocinetica di olaparib in pazienti pediatrici affetti da tumori solidi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents.
    Studio per valutare se olaparib è sicuro e ben tollerato quando somministrato a bambini e adolescenti
    A.3.2Name or abbreviated title of the trial where available
    Olaparib monotherapy in paediatric patients
    Olaparib in monoterapia in pazienti pediatrici
    A.4.1Sponsor's protocol code numberD0816C00025
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/262/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressForskargatan 18
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.4Telephone number0000000
    B.5.5Fax number000000
    B.5.6E-mailClinicalTrialTransparency@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name LYNPARZA®
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB - EU/1/14/959/002-003
    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 nameOlaparib 100 mg
    D.3.2Product code [AZD2281]
    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 INNOlaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeAZD2281
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 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 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 nameOlaparib 25 mg
    D.3.2Product code [AZD2281]
    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 INNOlaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeAZD2281
    D.3.9.3Other descriptive name-
    D.3.9.4EV Substance Code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 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: 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 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 nameSprinkle capsule olaparib 15 mg
    D.3.2Product code [AZD2281]
    D.3.4Pharmaceutical form Granules
    D.3.4.1Specific paediatric formulation Yes
    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 INNolaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeAZD2281
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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: 4
    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 nameSprinkle capsule olaparib 19.5 mg
    D.3.2Product code [AZD2281]
    D.3.4Pharmaceutical form Granules
    D.3.4.1Specific paediatric formulation Yes
    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 INNolaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeAZD2281
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number19500
    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.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
    Solid Tumours
    Tumori solidi
    E.1.1.1Medical condition in easily understood language
    Malignant cancer
    Cancro maligno
    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
    To describe the safety and tolerability of olaparib monotherapy and identify the RP2D of olaparib in the paediatric population.
    Descrivere la sicurezza e la tollerabilità di olaparib in monoterapia e identificare la RP2D di olaparib nella popolazione pediatrica.
    E.2.2Secondary objectives of the trial
    - To describe the paediatric PK profile and to identify the adult equivalent (300 mg bd tablet) dose based upon PK modelling.
    - To describe anti-tumour activity based upon RECIST v1.1 criteria, INRC, or RANO in paediatric patients with measurable or non-measurable assessable disease including in the subset of the minimum of 10 patients with deleterious or suspected deleterious HRR gene mutations.
    - Descrivere il profilo farmacocinetico pediatrico e identificare la dose equivalente somministrata negli adulti (compressa da 300 mg due volte al giorno) in base alla modellazione della farmacocinetica
    - Descrivere l'attività antitumorale in base ai criteri RECIST v1.1, INRC o RANO in pazienti pediatrici con malattia valutabile misurabile o non misurabile, incluso nel sottogruppo del minimo di 10 pazienti con mutazioni del gene HRR deleterie o sospette deleterie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Paediatric patients with pathologically confirmed relapsed or refractory solid or primary CNS tumours (excluding lymphoid malignancies), with a HRR deficiency/gene mutation, and for whom there are no standard treatment options. Eligible patients may include but not be limited to those with osteosarcoma, rhabdomyosarcoma, nonrhabdomyosarcoma soft tissue sarcoma, Ewing Sarcoma, neuroblastoma, medulloblastoma and glioma..
    (a) Any number of prior treatment regimens allowed.
    (b) A select group of first-line patients may be considered on a case by case basis to be eligible for screening and enrolment. These patients will be enrolled based on Investigator assessment after discussion with the sponsor as patients for whom no curative standard of care treatment options exist or such therapies are not tolerable.
    2 A formalin fixed, paraffin embedded (FFPE) tumour sample from the primary cancer (all patients) suitable for central HRR testing and a blood sample (patients =2 years old) for central germline BRCA testing must be provided for each patient for central laboratory assessment. Patients with a known HRR deficiency/gene mutation (based on local testing) are not required to wait for the results of the central test to proceed with the main part of the study, assuming all other eligibility criteria are met. The blood sample (from patients with a known HRR deficiency/gene mutation) and tumour sample should be shipped to the central laboratory following consent; patients with unknown HRR deficiency status will have their blood samples sent for central evaluation prior to enrolment.
    (a) A FFPE tumour tissue block is required, but if not available, tissue sections are accepted. The tumour specimen submitted should be of sufficient quantity
    (b) Patients who don't have an archival tumour sample may be allowed to provide a newly biopsied FFPE tumour tissue sample provided the sample is taken as part of routine clinical practice. The most recent sample available should be provided. Tumour lesions used for newly acquired biopsies should not be the same lesions used as RECIST v1.1, INRC or RANO target lesions, unless there are no other lesions suitable for biopsy (re-assessment after biopsy may be required).
    3 Lansky scale =50 for patients =16 years of age; or Karnofsky score = 50 for patients >16 years of age (see Appendix F).
    4 For all non-neuroblastoma tumours, patients must have at least 1 lesion (measurable and/or non-measurable), not previously irradiated, that can be accurately assessed at baseline and is suitable for repeated assessment using RECIST v1.1 or RANO.
    5 For neuroblastoma tumours, patients must have:
    (a) Radiographical assessable disease with at least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment using INRC; OR,
    (b) Disease evidenced by uptake of meta-iodobenzylguanidine- (MIBG) or fluorodeoxyglucose positron emission tomography (FDG-PET) scans.
    6 Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined in the protocol.
    Please refer to the protocol for full inclusion criteria.
    1 Pazienti pediatrici con tumori del SNC solidi o primari recidivanti o refrattari patologicamente confermati (escluse le neoplasie linfoidi), con un deficit di HRR/mutazione genica e per i quali non è prevista alcuna opzione di trattamento standard. Le patologie dei pazienti idonei possono includere, a titolo esemplificativo ma non esaustivo, osteosarcoma, rabdomiosarcoma, sarcoma dei tessuti molli non rabdomiosarcoma, sarcoma di Ewing, neuroblastoma, medulloblastoma e glioma.
    (a) Qualsiasi numero di regimi di trattamento precedenti.
    (b) Un gruppo selezionato di pazienti di prima linea può essere considerato, caso per caso, idoneo per lo screening e l’arruolamento. Questi pazienti saranno arruolati in base alla valutazione dello sperimentatore dopo averne discusso con lo sponsor, in qualità di pazienti per i quali non esistono opzioni terapeutiche standard o che non tollerano tali terapie.
    2 Per ciascun paziente devono essere forniti, ai fini di una valutazione del laboratorio centrale, un campione tumorale fissato in formalina e paraffinato (FFPE) ottenuto dal tumore primario (tutti i pazienti) adatto per il test HRR centrale e un campione di sangue (pazienti = 2 anni) per il test centrale dei BRCA della linea germinale. I pazienti con un noto deficit di HRR/mutazione genica (in base a test locali) non devono attendere i risultati del test centrale per procedere con la parte principale dello studio, a condizione che tutti gli altri criteri di idoneità siano soddisfatti. Il campione di sangue (da pazienti con deficit noto di HRR/mutazione genica) e il campione tumorale devono essere spediti al laboratorio centrale dopo il consenso; i campioni di sangue di pazienti con stato di deficit HRR non noto saranno inviati per la valutazione centrale prima dell'arruolamento.
    (a) È richiesto un blocco di tessuto tumorale FFPE; se non disponibile, sono accettate sezioni di tessuto. Il campione tumorale presentato deve essere in quantità sufficiente.
    (b) Ai pazienti che non dispongono di un campione tumorale d'archivio può essere consentito di fornire un campione di tessuto tumorale FFPE da biopsia recente a condizione che il campione venga prelevato nell'ambito della pratica clinica ordinaria. Deve essere fornito il campione disponibile più recente. Le lesioni tumorali utilizzate per le biopsie acquisite di recente non devono essere le stesse lesioni utilizzate come lesioni target RECIST v1.1, INRC o RANO, a meno che non vi siano altre lesioni idonee per la biopsia (potrebbe essere necessaria una rivalutazione dopo la biopsia).
    3 Scala di Lansky =50 per pazienti =16 anni; o punteggio di Karnofsky = 50 per pazienti di età >16 anni (vedere appendice F).
    4 Per tutti i tumori diversi dal neuroblastoma, i pazienti devono presentare almeno 1 lesione (misurabile e/o non misurabile), non precedentemente irradiata, che possa essere valutata accuratamente al basale e che sia adatta per una valutazione ripetuta utilizzando i criteri RECIST v1.1 o RANO.
    5 Per quanto riguarda i neuroblastomi, i pazienti devono presentare le seguenti condizioni:
    (a) malattia valutabile radiologicamente con almeno 1 lesione (misurabile e/o non misurabile) che può essere valutata con precisione al basale ed è adatta per una valutazione ripetuta utilizzando l’INRC; OPPURE,
    (b) Malattia evidenziata dall'assorbimento di meta-iodobenzilguanidina (MIBG) o tomografia a emissione di positroni con fluorodesossiglucosio (FDG-PET).
    6 Ai pazienti deve essere stata misurata la normale funzionalità degli organi e del midollo osseo nei 28 giorni precedenti la somministrazione del trattamento dello studio, come definito nel protocollo.
    Si prega di far riferimento al protocollo per la lista completa dei criteri di inclusione.
    E.4Principal exclusion criteria
    1 Patients with MDS/AML or with features suggestive of MDS/AML.
    2 Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study drug.
    3 Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, lymphopenia, and the laboratory values defined in the inclusion criterion. Patients with a toxicity not reasonably expected to be exacerbated by study treatment (eg, hearing loss, gastrostomy tube) may be included after consultation
    with the Study Physician.
    4 Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression,
    superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography scan, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, interstitial lung disease, or any psychiatric illness or social situations that would limit compliance with study requirements, substantially increase the risk of incurring AEs from IP, or compromise the ability of the patient to give written informed assent.
    5 History of other primary malignancy unless curatively treated with no evidence of disease for =5 years. Non-invasive malignancies such as adequately treated non-melanoma skin cancer or in situ carcinomas that have been adequately treated may be permitted after detailed discussion with the Study Physician.
    6 Patients with primary or metastatic CNS disease meeting the following criteria:
    (a) Symptomatic uncontrolled brain metastases at baseline. A scan to confirm the absence of brain metastases is not required.
    (b) Patients with brain metastases or primary brain tumours who require corticosteroids for management of symptoms or progression.
    (c) Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
    7 History of active primary immunodeficiency or immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).
    8 Patients with known active hepatitis (ie, Hepatitis B or C).
    (a) Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible.
    (b) Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid.
    9 Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the Investigator (eg, unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT interval (QTc) prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
    10 Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study treatment or interpretation of patient safety or study results.
    Please refer to the protocol for full exclusion criteria.
    1 Pazienti con SMD/LMA o con caratteristiche che suggeriscono SMD/LMA.
    2 Pazienti che non sono in grado di inghiottire il farmaco somministrato per via orale e pazienti con disturbi gastrointestinali che potrebbero interferire con l'assorbimento del farmaco in studio.
    3 Qualsiasi tossicità non risolta di grado NCI CTCAE =2 da precedente terapia antitumorale, ad eccezione di alopecia, vitiligine, linfopenia e dei valori di laboratorio definiti nel criterio di inclusione. I pazienti con una tossicità che non si prevede possa essere peggiorata dal trattamento dello studio (ad es., perdita dell'udito, tubo per gastrostomia) possono essere inclusi dopo aver consultato il medico dello studio.
    4 Pazienti considerati ad alto rischio medico a causa di una malattia seria non controllata, una patologia sistemica non maligna o un’infezione attiva non controllata. Esempi di questi disturbi includono, a titolo puramente indicativo, aritmia ventricolare non controllata, infarto miocardico recente (nei 3 mesi precedenti), disturbo convulsivo maggiore non controllato, compressione instabile del midollo spinale, sindrome della vena cava superiore, estesa malattia polmonare interstiziale bilaterale rilevata da tomografia computerizzata ad alta risoluzione, infezione attiva o in corso, insufficienza cardiaca congestizia sintomatica, aritmia cardiaca, malattia polmonare interstiziale o qualsiasi malattia psichiatrica o condizione sociale che limiterebbero la conformità ai requisiti dello studio, aumenterebbero in modo sostanziale il rischio di incorrere in AE dovuti al farmaco sperimentale (IP) o comprometterebbero la capacità del paziente di fornire un assenso informato scritto.
    5 Anamnesi di altre neoplasie primarie a meno che non siano state trattate a scopo curativo senza evidenza di malattia per =5 anni. Le neoplasie non invasive, come il carcinoma cutaneo non melanoma adeguatamente trattato o i carcinomi in situ che sono stati adeguatamente trattati, possono essere consentite dopo una discussione dettagliata con il medico dello studio.
    6 Pazienti con malattia del SNC primaria o metastatica che soddisfano i seguenti criteri:
    (a) Metastasi cerebrali non controllate sintomatiche al basale. Non è necessaria una scansione per confermare l'assenza di metastasi cerebrali.
    (b) Pazienti con metastasi cerebrali o tumori cerebrali primari che necessitano di corticosteroidi per la gestione o la progressione dei sintomi.
    (c) Pazienti con compressione del midollo spinale, a meno che non si ritenga che questi abbiano ricevuto un trattamento definitivo per questa patologia e presentino evidenza di malattia clinicamente stabile per 28 giorni.
    7 Anamnesi di immunodeficienza primaria attiva o pazienti immunocompromessi, ad es. pazienti noti per essere sierologicamente positivi al virus dell'immunodeficienza umana (HIV).
    8 Pazienti con epatite attiva nota (ovvero, epatite B o C).
    (a) Il virus dell'epatite B attivo (HBV) è definito come un risultato positivo noto dell'antigene di superficie dell'epatite B (HBsAg). Sono idonei i pazienti con infezione HBV passata o risolta (definita come presenza dell'anticorpo core contro epatite B e assenza di HBsAg).
    (b) I pazienti positivi agli anticorpi contro epatite C (HCV) sono idonei solo qualora l’analisi PCR (reazione a catena della polimerasi) sia negativa relativamente all’RNA dell’HCV.
    9 ECG a riposo che indica condizioni cardiache non controllate, potenzialmente reversibili, secondo il giudizio dello sperimentatore (ad es., ischemia instabile, aritmia sintomatica non controllata, insufficienza cardiaca congestizia, prolungamento dell'intervallo QT corretto (QTc) >500 ms, disturbi elettrolitici, ecc.) o pazienti con sindrome congenita del QT lungo.
    10Qualsiasi condizione che, secondo il parere dello sperimentatore, potrebbe interferire con la valutazione del trattamento dello studio o con l'interpretazione della sicurezza del paziente o dei risultati dello studio.
    Far riferimento al protocollo per la lista completa.
    E.5 End points
    E.5.1Primary end point(s)
    DLTs, RP2D, AEs/SAEs/deaths, discontinuation rate of olaparib treatment due to AEs throughout the study, clinical chemistry/haematology parameters, vital signs.
    DLT, RP2D, AE/SAE/decessi, tasso di interruzione del trattamento con olaparib a causa di AE durante lo studio, parametri di chimica clinica/ematologia, parametri vitali
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to the Schedule of Assessments of the protocol.
    Si prega di fare riferimento al "Programma delle Valutazioni" del protocollo
    E.5.2Secondary end point(s)
    - PK parameters: CLss/F, Css,max, Css, min, tss,max, AUCss, dose normalised AUCss, AUC(0-8), AUC0-t, and dose normalised Css,max
    - ORR, DCR and DoR as defined by Investigator-assessed RECIST v1.1, INRC, or RANO
    - PK parameters: CLss/F, Css,max, Css, min, tss,max, AUCss, dose normalised AUCss, AUC(0-8), AUC0-t, and dose normalised Css,max
    - ORR, DCR and DoR as defined by Investigator-assessed RECIST v1.1, INRC, or RANO
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to the Schedule of Assessments of the protocol.
    Please refer to the Schedule of Assessments of the protocol.
    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 Yes
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Determination of the recommended Phase II dose (RP2D) in paediatric patients
    Determinazione della dose raccomandata di Fase II (RP2D) in pazienti pediatrici
    E.7.2Therapeutic exploratory (Phase II) No
    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 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 trial15
    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 EEA25
    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
    Israel
    Korea, Republic of
    Denmark
    France
    Germany
    United Kingdom
    Spain
    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
    LSLV
    LSLV
    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 Yes
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 16
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants and adolescents aged 6 months - 15 years will be represented
    by legally designated representative(s)/parent(s)
    Infants and adolescents aged 6 months - 17 years will be represented by legally designated representative(s)/parent(s)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 48
    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)
    The clinical study database will close to new data at the time of the final data cut. Patients are, however, permitted to continue to receive study treatment beyond the closure of the database, if, in the opinion of the Investigator, they are continuing to receive benefit.
    The clinical study database will close to new data at the time of the final data cut. Patients are, however, permitted to continue to receive study treatment beyond the closure of the database, if, in the opinion of the Investigator, they are continuing to receive benefit.
    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 Decision2022-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-06
    P. End of Trial
    P.End of Trial StatusOngoing
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