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    Summary
    EudraCT Number:2020-004553-72
    Sponsor's Protocol Code Number:LOXO-BTK-20019
    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:2021-06-07
    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 number2020-004553-72
    A.3Full title of the trial
    A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator Choice of BTK Inhibitor in Patients with Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)
    Studio di fase 3, in aperto, randomizzato con LOXO-305 rispetto alla scelta dello sperimentatore dell’inibitore della BTK in pazienti con linfoma a cellule mantellari naïve all’inibitore della BTK precedentemente trattati (BRUIN MCL-321)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the effectiveness and safety of LOXO-305 compared to standard of care treatment chosen by the Investigator in patients with previously treated Mantle Cell Lymphoma
    Studio clinico per valutare l’efficacia e la sicurezza di LOXO-305 rispetto al trattamento standard di cura scelto dallo sperimentatore in pazienti affetti da linfoma a cellule mantellari precedentemente trattato
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberLOXO-BTK-20019
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04662255
    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 SponsorLOXO ONCOLOGY INCORPORATED
    B.1.3.4CountryUnited States
    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 supportLoxo Oncology Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIQVIA RDS GmbH
    B.5.2Functional name of contact pointMedical and Scientific Services
    B.5.3 Address:
    B.5.3.1Street AddressUnterschweinstiege 2-14.
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60549
    B.5.3.4CountryGermany
    B.5.4Telephone number0000000
    B.5.5Fax number0000000
    B.5.6E-mailmarialeticia.solari@iqvia.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 IMBRUVICA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1115
    D.3 Description of the IMP
    D.3.1Product nameIbrutinib
    D.3.2Product code [na]
    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 INNIbrutinib
    D.3.9.1CAS number 936563-96-1
    D.3.9.2Current sponsor codeIBRUTINIB
    D.3.9.4EV Substance CodeSUB120863
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 RoleComparator
    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 IMBRUVICA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1115
    D.3 Description of the IMP
    D.3.1Product nameIbrutinib
    D.3.2Product code [na]
    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 INNIbrutinib
    D.3.9.1CAS number 936563-96-1
    D.3.9.2Current sponsor codeIBRUTINIB
    D.3.9.4EV Substance CodeSUB120863
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number560
    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 nameLOXO-305
    D.3.2Product code [LOXO-305]
    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.3.9.1CAS number 2101700-15-4
    D.3.9.2Current sponsor codeLOXO-305
    D.3.9.4EV Substance CodeSUB215610
    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: 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 nameLOXO-305
    D.3.2Product code [LOXO-305]
    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.3.9.1CAS number 2101700-15-4
    D.3.9.2Current sponsor codeLOXO-305
    D.3.9.4EV Substance CodeSUB215610
    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.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
    Mantle cell lymphoma
    Linfoma mantellare
    E.1.1.1Medical condition in easily understood language
    a cancer of white blood cells (developing in a certain part of the lymph node), which help the body fight infections
    tumore (che si manifesta in una determinata zona dei linfonodi) dei globuli bianchi che aiutano l’organismo a combattere le infezioni
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10026799
    E.1.2Term Mantle cell lymphoma NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare progression-free survival (PFS) of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)
    Confrontare la sopravvivenza libera da progressione (PFS) di LOXO-305 in monoterapia (Braccio A) rispetto alla scelta dello sperimentatore di un inibitore irreversibile di BTK in monoterapia (Braccio B) in pazienti con linfoma a cellule mantellari (MCL) precedentemente trattato
    E.2.2Secondary objectives of the trial
    -To compare efficacy of LOXO-305 as monotherapy (Arm A) to
    investigator choice of covalent BTK inhibitor monotherapy (Arm B)
    treatment arms
    -To evaluate the safety and tolerability of each treatment arm
    -To evaluate the patient-reported outcomes
    -Confrontare l’efficacia di LOXO-305 in monoterapia (Braccio A) rispetto alla scelta dello sperimentatore di un inbitore irreversibile di BTK in monoterapia (Braccio B)
    -Valutare la sicurezza e la tollerabilità di ciascun braccio di trattamento
    -Valutare gli esiti riferiti dal paziente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • At least 18 years of age
    • Confirmed diagnosis by local laboratory of MCL with documentation of overexpression of cyclin D1 with at least one B-cell marker (e.g., CD19, CD20, or PAX5) and/or t (11;14), by cytogenetics, fluorescent in situ
    hybridization (FISH) or polymerase chain reaction.
    • Previously treated with at least one prior line of systemic therapy for MCL.
    • Measurable disease on radiologic assessment as defined by Lugano criteria: at least one nodal lesion (> 1.5 cm in long axis) or extra-nodal lesion (> 1.0 cm in long axis) measurable in 2 dimensions, not
    previously radiated (unless progression has been radiographically documented following radiation therapy).
    • Documented evidence of radiographically and/or histologically confirmed PD on the most recent line of therapy or relapse prior to study enrollment.
    • ECOG 0-2.
    • Adequate organ function
    • Must have life expectancy of at least 3 months
    Almeno 18 anni di età
    • Diagnosi, confermata dal laboratorio locale, di MCL con documentazione di sovraespressione di ciclina D1 con almeno un marcatore delle cellule B (ad es. CD19, CD20 o PAX5) e/o traslocazione cromosomica (11;14), tramite citogenetica, ibridazione fluorescente in situ (FISH) o reazione a catena della polimerasi.
    • Precedentemente trattati con almeno una precedente linea di terapia sistemica per l'MCL.
    • Malattia misurabile in base alla valutazione radiologica definita secondo i criteri di Lugano: almeno una lesione nodale (>1,5 cm lungo l’asse maggiore) o lesione extra-nodale (>1,0 cm lungo l’asse lungo maggiore) misurabile in 2 dimensioni, non precedentemente irradiata (a meno che la progressione non sia stata documentata radiograficamente dopo la radioterapia).
    • Evidenza documentata di PD [malattia progressiva] confermata radiograficamente e/o istologicamente sulla linea di terapia più recente o recidiva prima dell’arruolamento nello studio.
    • ECOG 0-2.
    • Funzione d’organo adeguata
    • Aspettativa di vita di almeno 3 mesi
    E.4Principal exclusion criteria
    • Current suspected or confirmed active CNS involvement with MCL or previous CNS involvement.
    • Prior treatment with an approved or investigational BTK inhibitor.
    • Major surgery within 4 weeks prior to randomization.
    • History of bleeding diathesis.
    • History of stroke or intracranial hemorrhage within 6 months of randomization.
    • History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within 60 days of randomization.
    • Significant cardiovascular disease.
    • Prolongation of the QT interval corrected for heart rate (QTcF) > 470 msec on at least 2/3 consecutive electrocardiograms (ECGs), and mean QTcF > 470 msec on all 3 ECGs, during Screening.
    • Known human immunodeficiency virus (HIV) infection, regardless of CD4 count.
    • Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
    • Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible.
    • Pregnancy, lactation or plan to breastfeed during the study or within 30 days of the last dose of study treatment.
    • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.
    • Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically
    significant active disease process which in the opinion of the investigator and medical monitor may pose a risk for patient participation. Screening for chronic conditions is not required.
    • History of second malignancy unless in remission for at least 2 years; in-situ carcinomas not requiring treatment intervention and nonmetastatic breast or prostate cancer where hormonal therapy is being
    continued as standard of care are allowed.
    Prior/Concomitant Therapy
    • Current treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong P-gp inhibitors. Because of their effect on CYP3A4, use of any of the following within 3 days of study therapy start or planned use during study participation is prohibited: grapefruit or grapefruit products, Seville oranges or products from Seville oranges, star fruit.
    • Steroid use with anti-neoplastic intent within 7 days of study drug initiation.
    • Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.
    • Vaccination with live vaccine within 28 days prior to randomization.
    • Have a known hypersensitivity to any of the excipients of LOXO-305 or to the intended covalent BTK inhibitor if randomized to control arm.
    • Coinvolgimento in corso del SNC a causa di MCL sospetto o confermato o precedente coinvolgimento del SNC.
    • Precedente trattamento con un inibitore di BTK approvato o sperimentale.
    • Intervento chirurgico maggiore nelle 4 settimane precedenti la randomizzazione.
    • Anamnesi di diatesi emorragica.
    • Anamnesi di ictus o emorragia intracranica nei 6 mesi precedenti la randomizzazione.
    • Anamnesi di trapianto allogenico o autologo di cellule staminali (SCT) o terapia con cellule T chimeriche modificate (CAR-T) nei 60 giorni precedenti la randomizzazione.
    • Malattie cardiovascolari significative.
    • Prolungamento dell’intervallo QT corretto per la frequenza cardiaca (QTcF) > 470 msec su almeno 2 di 3 elettrocardiogrammi (ECG) eseguiti consecutivamente e QTcF medio > 470 msec su tutti i 3 ECG, durante lo screening.
    • Infezione nota da virus dell’immunodeficienza umana (HIV), indipendentemente dalla conta dei CD4.
    • Infezione nota da virus dell’epatite B (HBV) o da virus dell’epatite C (HCV).
    • Infezione nota attiva da citomegalovirus (CMV). Sono idonee le condizioni non note o negative.
    • Gravidanza, allattamento o previsioni di allattamento durante lo studio o entro 30 giorni dall’ultima dose del trattamento dello studio.
    • Sindrome da malassorbimento, in corso, clinicamente significativa o altra condizione che possa influire sull’assorbimento gastrointestinale (GI) del farmaco dello studio.
    • Evidenza di altra/e condizione/i clinicamente significativa/e non controllata/e, incluse, ma non limitate a infezioni sistemiche batteriche, virali, fungine o parassitarie non controllate (ad eccezione delle infezioni fungine delle unghie) o di altro processo patologico in corso, clinicamente significativo, che, a giudizio dello sperimentatore e del medical monitor, possa rappresentare un rischio per la partecipazione dei pazienti. Non è necessario alcuno screening per le condizioni croniche.
    • Anamnesi di seconda neoplasia maligna, a meno che non sia in remissione da almeno 2 anni. Carcinomi in situ che non richiedono intervento terapeutico e carcinoma mammario o prostatico non metastatici, in cui la terapia ormonale viene continuata come terapia standard, sono consentiti.

    Terapia precedente/concomitante
    • Trattamento in corso con potenti inibitori o induttori del citocromo P450 3A4 (CYP3A4) e/o potenti inibitori della P-gp. A causa della loro azione sul CYP3A4, l’assunzione di uno qualsiasi dei seguenti alimenti, entro 3 giorni dall’inizio della terapia dello studio o l’assunzione prevista durante la partecipazione allo studio, è vietato: pompelmo o prodotti a base di pompelmo, arance amare di Siviglia o prodotti a base di arance amare di Siviglia, carambola.
    • Utilizzo di steroidi come terapia antineoplastica entro 7 giorni dall’inizio della somministrazione del farmaco dello studio.
    • Pazienti che richiedono terapia anticoagulante con warfarin o altro antagonista della vitamina K.
    • Vaccinazione con vaccino vivo entro 28 giorni prima della randomizzazione.
    • Ipersensibilità nota a uno qualsiasi degli eccipienti di LOXO-305 o all'inibitore irreversibile della BTK se randomizzato al braccio di controllo.
    E.5 End points
    E.5.1Primary end point(s)
    Assessed by independent review committee (IRC)
    • PFS per Lugano criteria
    Valutazione da parte di un Comitato di revisione indipendente (IRC)
    • PFS [malattia progressiva o decesso per qualsiasi causa a seconda di quale evento si verifichi prima] secondo i criteri di Lugano
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time from the date of randomization until PD or death from any cause, whichever occurs first.
    Tempo che intercorre tra la data di randomizzazione e la PD o il decesso per qualsiasi causa, a seconda di quale evento si verifichi prima.
    E.5.2Secondary end point(s)
    Assessed by both investigator assessment and IRC
    • Overall response rate (ORR) per Lugano criteria
    • Duration of response (DOR) per Lugano criteria
    Assessed by investigator assessment:
    • PFS per Lugano criteria
    • OS
    • EFS
    • TTF
    • TTNT
    • PFS2
    Incidence and severity of serious adverse events (SAEs), adverse events (AEs), deaths, and clinical laboratory abnormalities per Common Terminology
    Criteria for Adverse Events (CTCAE v5.0)
    • Comparative tolerability: proportion of time with high side-effect burden
    • TTW of MCL-related symptoms
    Valutato sia dallo sperimentatore sia dall’IRC
    • Tasso di risposta complessiva (ORR) per i criteri di Lugano
    • Durata della risposta (DOR) per i criteri di Lugano

    Valutato dallo sperimentatore:
    • PFS secondo i criteri di Lugano
    • OS [decesso per qualsiasi causa]
    • EFS [data della malattia progressiva o inizio di un nuovo trattamento per MCL o ritiro dalla sperimentazione a causa di tossicità o decesso, a seconda di quale evento si verifichi prima]
    • TTF [endpoint composito, interruzione del trattamento per qualsiasi motivo]
    • TTNT [data della successiva terapia non specificata dal protocollo per il MCL progressivo]
    • PFS2 [progressione della malattia nel trattamento di linea successivo, o decesso per qualsiasi causa]
    Incidenza e gravità degli eventi avversi seri (SAE), degli eventi avversi (EA), dei decessi e delle anomalie cliniche di laboratorio in base alla terminologia comune
    Criteri terminologici comuni per gli eventi avversi (CTCAE v5.0)
    • Tollerabilità comparativa: percentuale di tempo di esposizione ad effetti collaterali
    importanti
    • TTW [periodo di peggioramento] dei sintomi correlati al MCL
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR - achieving a BOR of CR or PR
    DOR - earlier of the documentation of definitive PD or death from any cause
    PFS - PD or death from any cause, whichever occurs first
    OS - death from any cause
    EFS - date of PD or start of new treatment for MCL or withdrawal from trial due to toxicity or death, whichever occurs first
    TTF - composite endpoint, discontinuation of treatment for any reason
    TTNT - date of the next non-protocol-specified therapy for progressive MCL
    PFS 2 - disease progression on next line treatment, or death from any cause
    ORR - ottenimento della BOR di CR o PR
    DOR - precedentemente alla documentazione di malattia progressiva definitiva o decesso per qualsiasi causa
    PFS - malattia progressiva o decesso per qualsiasi causa, a seconda di quale evento si verifichi prima
    OS - decesso per qualsiasi causa
    EFS - data della malattia progressiva o inizio di un nuovo trattamento per MCL o ritiro dalla sperimentazione a causa di tossicità o decesso, a seconda di quale evento si verifichi prima
    TTF - endpoint composito, interruzione del trattamento per qualsiasi motivo
    TTNT - data della successiva terapia non specificata dal protocollo per MCL progressivo
    PFS 2 - progressione della malattia nel successivo trattamento di linea, o decesso per qualsiasi causa
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Australia
    Canada
    China
    Israel
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    New Zealand
    Russian Federation
    Singapore
    Taiwan
    United States
    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 study is estimated at approximately 24 months from the last subject randomized
    Fine della sperimentazione è stimata approssimativamente 24 mesi dopo la randomizzazione dell'ultimo paziente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 169
    F.4.2.2In the whole clinical trial 500
    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)
    Patients receiving LOXO-305 may continue on this treatment until the patient is able to obtain commercially available LOXO-305 in their respective country, if the patient does not meet criteria requiring discontinuation of treatment, and the patient's participation in the study has not ended.
    Patients receiving LOXO-305 may continue on this treatment until the patient is able to obtain commercially available LOXO-305 in their respective country, if the patient does not meet criteria requiring discontinuation of treatment, and the patient's participation in the study has not ended.
    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 Decision2021-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-22
    P. End of Trial
    P.End of Trial StatusOngoing
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