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    Summary
    EudraCT Number:2021-000248-23
    Sponsor's Protocol Code Number:C3441052
    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:2021-08-30
    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 number2021-000248-23
    A.3Full title of the trial
    TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC
    CASTRATION-SENSITIVE PROSTATE CANCER
    TALAPRO-3: STUDIO DI FASE 3, RANDOMIZZATO, IN DOPPIO CIECO CHE VALUTA TALAZOPARIB ED ENZALUTAMIDE RISPETTO A PLACEBO EDENZALUTAMIDE IN UOMINI AFFETTI DA CARCINOMA METASTATICO DELLA PROSTATA SENSIBILI ALLA CASTRAZIONE E CON MUTAZIONE DDR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Randomized Study of Talazoparib with Enzalutamide in Men with DDR Gene Mutated mCSPC
    Studio di fase 3, randomizzato su talazoparib con enzalutamide in uomini con tumore alla prostata sensibile alla castrazione, metastatico (mCSPC), con mutazione del gene DDR
    A.3.2Name or abbreviated title of the trial where available
    TALAPRO-3
    TALAPRO-3
    A.4.1Sponsor's protocol code numberC3441052
    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 SponsorPFIZER INC
    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 supportPfizer Inc, 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 No
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTalazoparib
    D.3.2Product code [PF-06944076]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNtalazoparib
    D.3.9.2Current sponsor codePF-06944076
    D.3.9.4EV Substance CodeSUB183862
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 nameTalazoparib
    D.3.2Product code [PF-06944076]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTalazoparib
    D.3.9.2Current sponsor codePF-06944076
    D.3.9.4EV Substance CodeSUB183862
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 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 Xtandi
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    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 nameXtandi 40 mg soft capsules
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Capsule, soft
    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 INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB77412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 nameTalazoparib
    D.3.2Product code [PF-06944076]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNtalazoparib
    D.3.9.2Current sponsor codePF-06944076
    D.3.9.4EV Substance CodeSUB183862
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Castration-sensitive Prostate Cancer
    tumore alla prostata sensibile alla castrazione metastatico
    E.1.1.1Medical condition in easily understood language
    Metastatic Castration-sensitive Prostate Cancer
    tumore alla prostata sensibile alla castrazione metastatico
    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 PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that talazoparib in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging investigator-assessed rPFS, in participants with mCSPC harboring DDR
    deficiencies.
    Dimostrare che talazoparib in combinazione con enzalutamide è superiore al placebo in combinazione con enzalutamide nel prolungare la rPFS valutata dallo sperimentatore nei partecipanti con mCSPC che presentano deficit di DDR.
    E.2.2Secondary objectives of the trial
    Key Secondary Objective
    •To demonstrate that talazoparib in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging OS in participants with mCSPC harboring DDR deficiencies.
    Other Secondary Objectives
    •To evaluate antitumor activity in participants with mCSPC harboring DDR deficiencies with respect to the following:
    •Objective response in measurable soft tissue disease;
    •Duration of response in measurable soft tissue disease;
    •PSA response;
    •Time to PSA progression;
    •Time to initiation of antineoplastic therapy;
    •Time to first symptomatic skeletal event;
    •Opiate use for prostate cancer pain.
    •To evaluate safety of talazoparib and enzalutamide administered in combination.
    •To evaluate the PK of talazoparib and enzalutamide (and its N desmethyl metabolite) when dosed in combination.
    Dimostrare che talazoparib in combinazione con enzalutamide è superiore al placebo in combinazione con enzalutamide nel prolungare la OS valutata dallo sperimentatore nei partecipanti con mCSPC che presentano deficit di DDR.
    Altri obiettivi:
    -Valutare l’attività antitumorale nei partecipanti con mCSPC che presentano deficit di DDR in relazione a quanto segue:
    -Risposta obiettiva nella malattia misurabile dei tessuti molli;
    -Durata della risposta nella malattia misurabile dei tessuti molli;
    -Risposta del PSA;
    -Tempo alla progressione del PSA;
    -Tempo all’inizio della terapia antitumorale;
    - Tempo al primo evento scheletrico sintomatico;
    -Uso di oppiacei per il dolore dovuto al tumore alla prostata.
    - Valutare la sicurezza della somministrazione combinata di talazoparib ed enzalutamide.
    - Valutare la PK di talazoparib ed enzalutamide (e del suo metabolita N-desmetile) in somministrazione combinata.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age and Sex:
    1.Male participants at least 18 years of age at screening. Refer to Appendix 4 of the protocol for reproductive criteria for male participants.
    Type of Participant and Disease Characteristics:
    2.Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell features. If the participant does not have a prior histological diagnosis, a baseline de novo biopsy must
    be used to confirm the diagnosis and may also be used to support biomarker analysis.
    3.Confirmation of DDR gene mutation status by prospective or historical analysis (with sponsor pre-approval) of blood (liquid biopsy) and/or de novo or archival tumor tissue using FoundationOne Liquid CDx or
    FoundationOne CDx.
    4.Willing to provide tumor tissue when available (de novo or archived) for retrospective molecular profiling analysis, if not already provided as part of inclusion criterion 3.
    5.Unless prohibited by local regulations or ethics committee decision, consent to a saliva sample collection for retrospective sequencing of the same DDR genes tested on tumor tissue and blood (liquid biopsy), or a
    subset thereof, and to serve as a germline control in identifying tumor mutations.
    6.Surgically or medically castrated, with serum testosterone =50 ng/dL (=1.73 nmol/L) at screening. Ongoing ADT with a GnRH agonist or antagonist for participants who have not undergone bilateral
    orchiectomy must be initiated at least 4 weeks before randomization and must continue throughout the study.
    7.Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesions on CT or MRI scan (for soft tissue).
    For complete list see section 5.2. of the protocol study
    I partecipanti sono idonei a essere inclusi nello studio solo se soddisfano tutti i seguenti criteri:
    Età e sesso:
    1. Partecipanti di sesso maschile di almeno 18 anni di età allo screening. Fare riferimento all’Appendice 4 per i criteri riproduttivi per i partecipanti di sesso maschile.
    Caratteristiche dei partecipanti e della malattia:
    2. Adenocarcinoma della prostata confermato istologicamente o citologicamente, senza caratteristiche a piccole cellule o a cellule ad anello con castone. Se il partecipante non presenta una precedente diagnosi istologica, per confermare la diagnosi deve essere utilizzata una biopsia de novo al basale, che può essere utilizzata anche a sostegno dell’analisi dei biomarcatori.
    3. Conferma dello stato della mutazione del gene DDR mediante analisi prospettica o storica (previa approvazione dello sponsor) del sangue (biopsia liquida) e/o del tessuto tumorale de novo o d’archivio utilizzando FoundationOne Liquid CDx o FoundationOne CDx.
    4. Disponibilità a fornire tessuto tumorale ove disponibile (de novo o d’archivio) per l’analisi retrospettiva di profilazione molecolare, se non già fornito nell’ambito del Criterio di inclusione 3.
    5. A meno che non sia vietato dalle normative locali o dalla decisione del comitato etico, acconsentire alla raccolta di un campione di saliva per il sequenziamento retrospettivo degli stessi geni DDR analizzati nel tessuto tumorale e nel sangue (biopsia liquida), o su un sottogruppo, che funga da controllo della linea germinale nell’identificazione delle mutazioni tumorali.
    6. Castrazione chirurgica o medica, con livelli di testosterone sierico = 50 ng/dl (= 1,73 nmol/l) allo screening. L’ADT in corso, con un agonista o antagonista del GnRH per i partecipanti che non sono stati sottoposti a orchiectomia bilaterale, deve essere iniziata almeno 4 settimane prima della randomizzazione e deve continuare per tutta la durata dello studio.
    7. Tumore alla prostata metastatico documentato mediante scintigrafia ossea positiva (per malattia ossea) o lesioni metastatiche alla TC o RM (per i tessuti molli). I partecipanti la cui diffusione della malattia è limitata ai linfonodi pelvici regionali non sono idonei. NB: un risultato di superscan al basale è motivo di esclusione
    per la lista completa vedere la sezione 5.2 del protocollo di studio
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical Conditions:
    1.Other acute or chronic medical (concurrent disease, infection or comorbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality thatinterferes with a participant's ability to participate in the study, may increase the risk of associated with study participation or study treatment administration, or may interfere with the interpretation of study results, and, in the investigator's judgment, make the participant inappropriate for entry into the study.
    2.History of seizure or any condition (as assessed by investigator) that may predispose to seizure (eg, prior cortical stroke, significant brain trauma), including any history of loss of consciousness or transient
    ischemic attack within 12 months of randomization.
    3.Major surgery (as defined by the investigator) within 2 weeks before randomization.
    4.Known or suspected brain metastasis or active leptomeningeal disease.
    5.Symptomatic or impending spinal cord compression or cauda equina syndrome.
    6.Any history of MDS, AML, or prior malignancy except for the following:
    •Carcinoma in situ or non-melanoma skin cancer.
    •A cancer diagnosed and treated =3 years before randomization with no subsequent evidence of recurrence.
    •American Joint Committee on Cancer Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence in the opinion of the investigator and the sponsor.
    7.In the opinion of the investigator, any clinically significant gastrointestinal disorder affecting absorption.
    For a complete list please see section 5.2 of the protocol study
    I partecipanti sono esclusi dallo studio se soddisfano uno qualsiasi dei seguenti criteri:
    Condizioni mediche
    1. Altra condizione medica (malattia concomitante, infezione o comorbidità) o psichiatrica, acuta o cronica, tra cui comportamento/ideazione suicidaria recente (nell’ultimo anno) o attiva oppure anomalia di laboratorio che possa interferire con la capacità del partecipante di partecipare allo studio, aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del trattamento dello studio oppure interferire con l’interpretazione dei risultati dello studio e che, a giudizio dello sperimentatore, renda il paziente non idoneo all’ingresso nello studio.
    2. Anamnesi di crisi convulsiva o qualsiasi condizione (secondo la valutazione dello sperimentatore) che possa predisporre a una crisi convulsiva (ad es. precedente ictus corticale, trauma cerebrale significativo), compresa qualsiasi anamnesi di perdita di coscienza o attacco ischemico transitorio nei 12 mesi precedenti alla randomizzazione.
    3. Intervento di chirurgia maggiore (come definito dallo sperimentatore) nelle 2 settimane precedenti alla randomizzazione.
    4. Metastasi cerebrali note o sospette o malattia leptomeningea attiva.
    5. Compressione sintomatica o incombente del midollo spinale o sindrome della cauda equina.
    6. Qualsiasi anamnesi di SMD, LMA o precedente tumore maligno, fatta eccezione per quanto segue:
    - Tumore della pelle in situ o non melanoma.
    - Tumore diagnosticato e trattato = 3 anni prima della randomizzazione senza alcuna successiva evidenza di recidiva.
    -Tumore in stadio 0 o 1 secondo la classificazione del Comitato congiunto americano sul cancro < 3 anni prima della randomizzazione, che presenta una remota probabilità di recidiva secondo il parere dello sperimentatore e dello sponsor.
    7. A giudizio dello sperimentatore, qualsiasi disturbo gastrointestinale clinicamente significativo che influisca sull’assorbimento.
    Per la lista completa si prega di vedere la sezione 5.2 del protocollo di studio
    E.5 End points
    E.5.1Primary end point(s)
    Investigator-assessed rPFS per RECIST 1.1 (soft tissue disease) and PCWG3 (bone disease) in participants with mCSPC harboring DDR
    deficiencies.
    rPFS valutata dallo sperimentatore secondo i criteri RECIST 1.1 (malattia dei tessuti molli) e PCWG3 (malattia ossea) nei partecipanti con mCSPC che presentano deficit di DDR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Radiographic imaging is every 8 weeks through Week 57, (9, 17, 25, 33, 41, 49, 57) then every 12 weeks thereafter until study intervention is discontinued for radiographic progression.
    L'imaging radiografico si verifica ogni 8 settimane fino alla settimana 57 (9, 17, 25, 33, 41, 49, 57) e successivamente ogni 12 settimane fino all'interruzione dell'intervento chirurgico per la progressione radiografica.
    E.5.2Secondary end point(s)
    •OS in participants with mCSPC harboring DDR deficiencies (alpha protected).
    •Proportion of participants with measurable soft tissue disease at
    baseline with an objective response per RECIST 1.1.
    •Duration of soft tissue response per RECIST 1.1.
    •Proportion of participants with PSA response 50% in participants with
    detectable PSA values at baseline..
    •Time to PSA progression.
    •Time to initiation of antineoplastic therapy.
    •Time to first symptomatic skeletal event.
    •Time to opiate use for prostate cancer pain.
    •Incidence of AEs characterized by type, severity (graded by NCI CTCAE version 4.03), timing, seriousness and relationship to study intervention.
    •Predose trough plasma concentrations of talazoparib, enzalutamide and its N-desmethyl metabolite
    •Change from baseline in participant-reported pain symptoms per BPISF;
    •Change from baseline in participant-reported general health status per EQ-5D-5L;
    •Change from baseline in participant-reported cancer specific global health status/QoL, functioning, and symptoms per EORTC QLQ-C30;
    •Time to deterioration in participant-reported pain symptoms per BPISF;
    •Time to definitive deterioration in participant-reported global health status/QoL per EORTC QLQ-C30;
    •Time to definitive deterioration in participant-reported disease specific urinary symptoms per EORTC QLQ-PR25.
    •Change from baseline in PGI-S.
    •ctDNA burden at baseline and on study, as assessed using FoundationOne liquid or another suitable validated assay.
    OS nei partecipanti con mCSPC che presentano deficit di DDR (alfa-protette).
    -Percentuale di partecipanti con malattia misurabile dei tessuti molli al basale con una risposta obiettiva secondo i criteri RECIST 1.1.
    - Durata della risposta nei tessuti molli secondo i criteri RECIST 1.1.
    - Percentuale di partecipanti con risposta del PSA pari al 50% nei partecipanti con valori di PSA rilevabili al basale.
    -Tempo alla progressione del PSA.
    - Tempo all’inizio della terapia antitumorale.
    - Tempo al primo evento scheletrico sintomatico.
    - Tempo all’uso di oppiacei per il dolore dovuto al tumore alla prostata.
    - Incidenza di EA caratterizzati per tipo, gravità (classificata in base ai criteri terminologici comuni per gli eventi avversi [CTCAE] del National Cancer Institute [NCI] versione 4.03), tempistica, gravità e tipo di rapporto con il trattamento dello studio.
    -Concentrazioni plasmatiche di valle pre-dose di talazoparib, enzalutamide e del suo metabolita N-desmetil.
    Variazione rispetto al basale dei sintomi del dolore riferiti dal partecipante mediante BPI-SF;
    - Variazione rispetto al basale nello stato di salute generale riferito dal partecipante secondo il questionario europeo della qualità della vita a 5 dimensioni con scala a 5 livelli (EQ-5D-5L);
    -Variazione rispetto al basale dello stato di salute complessivo specifico per il tumore/qualità della vita, della funzionalità e dei sintomi riferiti dal partecipante mediante il questionario QLQ-C30 di EORTC;
    - Tempo al peggioramento dei sintomi di dolore riferiti dal partecipante mediante il BPI-SF
    -Tempo al deterioramento definitivo dello stato di salute complessivo/QoL riferiti dal partecipante secondo QLQ-C30 di EORTC;
    - Tempo al peggioramento definitivo dei sintomi urinari specifici della malattia riferiti dal partecipante secondo QLQ-PR25 di EORTC.
    - Variazione rispetto al basale dell’impressione globale del paziente in merito alla gravità (PGI-S).
    -Carico di ctDNA al basale e durante lo studio, valutato utilizzando il FoundationOne Liquid o un altro test idoneo convalidato.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As per protocol , through the treatment period and long term follow up
    Come da protocollo, durante il periodo di trattamento e il follow-up a lungo termine
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    India
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Russian Federation
    South Africa
    Turkey
    Ukraine
    United States
    Belgium
    Bulgaria
    Finland
    France
    Germany
    Hungary
    Italy
    Netherlands
    Norway
    Slovakia
    Spain
    Sweden
    United Kingdom
    Czechia
    Argentina
    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
    LVLS
    ultima visita dell'ultimo paziente
    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 months5
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days9
    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: 143
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 407
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 179
    F.4.2.2In the whole clinical trial 550
    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 difference from the expected normal treatment of that condition
    Nessuna differenza rispetto al normale trattamento previsto per quella condizione
    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 Decision2021-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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