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    Summary
    EudraCT Number:2020-002209-25
    Sponsor's Protocol Code Number:67652000PCR3002
    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:2021-05-24
    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 number2020-002209-25
    A.3Full title of the trial
    A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
    Studio di fase 3, randomizzato, controllato con placebo, in doppio cieco di niraparib in combinazione con abiraterone acetato e prednisone rispetto ad abiraterone acetato e prednisone per il trattamento di pazienti affetti da carcinoma prostatico metastatico sensibile alla castrazione (mCSPC), con mutazioni deleterie di tipo somatico o germinale nei geni che codificano per le proteine di riparazione con ricombinazione omologa (HRR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
    Studio di fase 3 di niraparib in combinazione con abiraterone acetato e prednisone rispetto ad abiraterone acetato e prednisone per il trattamento di pazienti affetti da carcinoma prostatico metastatico sensibile alla castrazione (mCSPC), con mutazioni deleterie di tipo somatico o germinale nei geni che codificano per le proteine di riparazione con ricombinazione omologa (HRR)
    A.3.2Name or abbreviated title of the trial where available
    AMPLITUDE
    AMPLITUDE
    A.4.1Sponsor's protocol code number67652000PCR3002
    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 SponsorJANSSEN CILAG INTERNATIONAL NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportJanssen Cilag SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 ZYTIGA
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZYTIGA 250 mg tablets
    D.3.2Product code [ZYTIGA 250 mg tablets]
    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 INN00323801
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor codeABIRATERONE ACETATE
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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.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 nameniraparib/abiraterone 50/500mg(G009)
    D.3.2Product code [CJNJ-67652000-G009]
    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 INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeJNJ-64091742
    D.3.9.3Other descriptive nameD.3.4 - Forma farmaceutica: compressa rivistita con film D.3.6.2.1 - valore: 100/1000 mg milligram(s)
    D.3.9.4EV Substance CodeSUB177208
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN00323801
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor codeABIRATERONE ACETATE
    D.3.9.3Other descriptive nameD.3.4 - Forma farmaceutica: compressa rivistita con film D.3.6.2.1 - valore: 100/1000 mg milligram(s)
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 nameniraparib/abiraterone 100/500mg(G010)
    D.3.2Product code [CJNJ-67652000-G010]
    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 INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeJNJ-64091742
    D.3.9.3Other descriptive nameD.3.4 - Forma farmaceutica: compressa rivistita con film D.3.6.2.1 - valore: 200/1000 mg milligram(s)
    D.3.9.4EV Substance CodeSUB177208
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN00323801
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor codeABIRATERONE ACETATE
    D.3.9.3Other descriptive nameD.3.4 - Forma farmaceutica: compressa rivistita con film D.3.6.2.1 - valore: 200/1000 mg milligram(s)
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 nameNiraparib 100 mg capsules
    D.3.2Product code [JNJ-64091742]
    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 INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeJNJ-64091742
    D.3.9.3Other descriptive nameniraparib tosylate monohydrate
    D.3.9.4EV Substance CodeSUB177208
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    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
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
    Carcinoma prostatico metastatico sensibile alla castrazione (mCSPC), con mutazioni deleterie di tipo somatico o germinale nei geni che codificano per le proteine di riparazione con ricombinazione omologa (HRR)
    E.1.1.1Medical condition in easily understood language
    Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
    Carcinoma prostatico metastatico sensibile alla castrazione (mCSPC), con mutazioni deleterie somatiche o germinali nei geni per le proteine di riparazione con ricombinazione omologa (HRR)
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 determine if niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC provides superior efficacy in improving rPFS
    Determinare se niraparib, AA e prednisone rispetto ad AA e prednisone nei pazienti affetti da mCSPC con mutazioni deleterie di tipo somatico o germinale nei geni che codificano per HRR offrano un’efficacia superiore nel migliorare la sopravvivenza libera da progressione radiografica (radiographic Progression-Free Survival, rPFS).
    E.2.2Secondary objectives of the trial
    - To assess the clinical benefit of niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC

    - To characterize the safety profile of niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC
    - Valutare il beneficio clinico di niraparib, AA e prednisone rispetto ad AA e prednisone nei pazienti affetti da mCSPC con mutazioni deleterie di tipo somatico o germinale nei geni che codificano per HRR.

    - Caratterizzare il profilo di sicurezza di niraparib, AA e prednisone rispetto ad AA e prednisone nei pazienti affetti da mCSPC con mutazioni deleterie di tipo somatico o germinale nei geni che codificano per HRR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 years of age or older
    2. Diagnosis of prostate adenocarcinoma.
    3. Willing to provide an archival tumor tissue sample or a fresh tumor tissue sample. If germline positive for deleterious germline or somatic HRR gene mutations, an archived or fresh tumor tissue sample is not required.
    4. Metastatic disease documented by >=1 bone lesion(s) on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by CT or MRI.
    5 Must have at least one of the deleterious germline or somatic HRR gene mutations listed in Table 4.
    6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade <2.
    7. Androgen deprivation therapy (either medical or surgical castration) must have been started >14 days prior to randomization and willing to continue through the treatment phase. Participants who start a GnRH agonist <28 days prior to randomization will be required to take a first-generation anti-androgen for >14 days prior to randomization. The anti-androgen must be discontinued prior to randomization.
    8. Participants who have received prior docetaxel treatment must meet the following criteria:
    a. Received a maximum of 6 cycles of docetaxel therapy for mCSPC
    b. Received the last dose of docetaxel <2 months prior to randomization
    c. Maintained a response to docetaxel of stable disease or better, by investigator
    assessment of imaging and PSA, prior to randomization.
    9. Other allowed prior therapy for mCSPC:
    a. Maximum of 1 course of radiation or surgical intervention to manage symptoms of prostate cancer. Radiation with curative intent is not allowed. Radiation must be completed prior to randomization.
    b. <6 months of ADT prior to randomization.
    c. 30 days of AA-P allowed if required.
    10. Allowed prior treatments for localized prostate cancer (all treatments must have been completed >=1 year prior to randomization):
    a. <=3 years total of ADT
    b. All other forms of prior therapies including radiation therapy, prostatectomy, lymph node dissection, and systemic therapies.
    11. Clinical laboratory values at Screening:
    a. Absolute neutrophil count >=1.5 x 109/L
    b. Hemoglobin >=9.0 g/dL, independent of transfusions for at least 28 days
    c. Platelet count >=100 x 109/µL
    d. Serum albumin >=3.0 g/dL
    e. Creatinine < 2 x upper limit of normal (ULN)
    f. Serum potassium >=3.5 mmol/L
    g. Serum total bilirubin <=1.5× ULN or direct bilirubin <=1 x ULN (Note: In participants with Gilbert’s syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin, and if direct bilirubin is <=1.5 × ULN, participant may be eligible as determined by the medical monitor)
    h. AST or ALT <=3 × ULN
    12. Able to swallow the study medication tablets whole.
    13. Must provide informed consent (written or remote/virtual) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study including providing a DNA sample.

    For full details of the inclusion criteria see page 30-31 of the protocol.
    1. >18 anni di età (o età legale del consenso locale).
    2. Diagnosi di adenocarcinoma prostatico.
    3. Disposto a fornire un campione di tessuto tumorale d’archivio o un campione di tessuto tumorale fresco. Se la linea germinale è positiva per mutazioni deleterie di tipo somatico o germinale nei geni che codificano per HRR, non è necessario un campione di tessuto tumorale d’archivio o fresco.
    4. Malattia metastatica documentata da >=1 lesione/i ossea/e alla scintigrafia ossea con 99mTc. I pazienti con una singola lesione ossea devono avere la conferma delle metastasi ossee mediante TC o RMI.
    5. Devono avere almeno una delle mutazioni deleterie di tipo somatico o germinale nei geni che codificano per HRR elencate nella Tabella 4.
    6. Performance status dell’Eastern Cooperative Oncology Group di Grado <2.
    7. La terapia di deprivazione androgenica (sia con castrazione medica che chirurgica) deve essere iniziata >14 giorni prima della randomizzazione e il soggetto deve essere disposto a continuarla nella fase di trattamento. Ai pazienti che avviano un agonista del GnRH <28 giorni prima della randomizzazione sarà richiesto di assumere un antiandrogeno di prima generazione per >14 giorni prima della randomizzazione. L’antiandrogeno deve essere interrotto prima della randomizzazione.
    8. I pazienti che hanno ricevuto il precedente trattamento con docetaxel devono soddisfare i seguenti criteri:
    a. aver ricevuto un massimo di 6 cicli di terapia con docetaxel per mCSPC
    b. aver ricevuto l’ultima dose di docetaxel <2 mesi prima della randomizzazione
    c. aver mantenuto una risposta a docetaxel di malattia stabile o migliorata, mediante valutazione dello sperimentatore della diagnostica per immagini e PSA, prima della randomizzazione.
    9. Altra terapia precedente consentita per mCSPC:
    a. massimo 1 ciclo di radioterapia o intervento chirurgico per gestire i sintomi del carcinoma prostatico. Le radiazioni con intento curativo non sono consentite. Le radiazioni devono essere completate prima della randomizzazione.
    b. <6 mesi di ADT prima della randomizzazione.
    c. Se necessario, sono consentiti 30 giorni di AA-P.
    10.Consentiti trattamenti precedenti per carcinoma prostatico localizzato (tutti i trattamenti devono essere stati completati >=1 anno prima della randomizzazione):
    a. <=3 anni in totale di ADT
    b. Tutte le altre forme di terapie precedenti, tra cui radioterapia, prostatectomia, dissezione dei linfonodi e terapie sistemiche.
    11.Valori clinici di laboratorio allo screening:
    a. conta assoluta dei neutrofili >=1,5 x 109/l
    b. Emoglobina >=9,0 g/dl, indipendente dalle trasfusioni per almeno 28 giorni
    c. Conta piastrinica >=100 x 109/µl
    d. Albumina sierica >=3,0 g/dl
    e. Creatinina < 2 x limite superiore della norma (Upper Limit of Normal, ULN)
    f. Potassio sierico >=3,5 mmol/l
    g. Bilirubina totale sierica <=1,5 x ULN o bilirubina diretta <=1 x ULN (Nota: nei partecipanti con sindrome di Gilbert, se la bilirubina totale è >1,5 x ULN, misurare la bilirubina diretta e indiretta e, se la bilirubina diretta è <=1,5 x ULN, il partecipante può essere eleggibile se confermato dal responsabile del monitoraggio medico)
    h. AST o ALT <=3 x ULN
    12.In grado di deglutire le compresse del farmaco dello studio intere.

    Per il dettaglio completo dei criteri di inclusione vedasi pagina 30-31 del protocollo.
    E.4Principal exclusion criteria
    1. Pathological finding consistent with small cell ductal or neuroendocrine carcinoma of the prostate.
    2. Prior treatment with a PARP inhibitor.
    3.Prior AR-targeted therapy (eg, ketoconazole for prostate cancer, apalutamide, enzalutamide, darolutamide), immunotherapy, or radiopharmaceutical agents with the exception of only 30 days of AA-P allowed prior to randomization.
    4. Initiation of treatment with a bisphosphonate or denosumab for the management of bone metastasis < 28 days prior to randomization.
    5. History of adrenal dysfunction
    6. Long-term use of systemically administered corticosteroids (>5 mg of prednisone or the equivalent) during the study is not allowed. Short-term use (<=4 weeks, including taper) and locally administered steroids (eg, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated.
    7. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are:
    a. non-muscle invasive bladder cancer;
    b. skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured;
    c. breast cancer – adequately treated lobular carcinoma in situ or ductal carcinoma in situ;
    d. malignancy that is considered cured with minimal risk of recurrence.
    8. History or current diagnosis of MDS/AML.
    9. Current evidence within 6 months prior to randomization of any of the following: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, clinically significant arterial or venous thromboembolic events (eg, pulmonary embolism), or clinically significant ventricular arrhythmias.
    10. Presence of sustained uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg). Participants with a history of hypertension are allowed, provided that blood pressure is controlled to within these limits by an antihypertensive
    treatment.
    11. Known allergies, hypersensitivity, or intolerance to the excipients of niraparib, AA, or niraparib/AA FDC (refer to the IBs for niraparib and AA).
    12. Current evidence of any medical condition that would make prednisone use contraindicated.
    13. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days before the planned first dose of study medication.
    14. Participants who have had the following <=28 days prior to randomization:
    a. A transfusion (platelets or red blood cells);
    b. Hematopoietic growth factors;
    c. Major surgery (sponsor should be consulted regarding what constitutes major surgery).
    15. Known active hepatitis B virus (eg, hepatitis B surface antigen reactive) or active hepatitis C virus (HCV; eg, HCV ribonucleic acid [RNA] [qualitative] is detected).
    16. Human immunodeficiency virus positive participants with 1 or more of the following:
    a. Not receiving highly active antiretroviral therapy or on antiretroviral therapy for less than 4 weeks.
    b. Receiving antiretroviral therapy that may interfere with the study medication (consult the sponsor for review of medication prior to enrollment).
    c. A change in antiretroviral therapy within 6 months of the start of screening (except if, after consultation with the sponsor on exclusion criterion 16.b, a change is made to avoid a potential drug-drug interaction with the study medication).
    d. CD4 count <350 at screening.
    e. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening.
    f. Human immunodeficiency virus load > 400 copies/mL.
    1.Determinazione patologica coerente con carcinoma duttale a piccole cellule o neuroendocrino della prostata.
    2.Precedente trattamento con un inibitore di PARP.
    3.Precedente terapia mirata ad AR (ad es. ketoconazolo per carcinoma prostatico, apalutamide, enzalutamide, darolutamide), immunoterapia o agenti radiofarmaceutici, ad eccezione di soli 30 giorni di AA-P consentiti prima della randomizzazione.
    4.Inizio del trattamento con un bifosfonato o denosumab per la gestione delle metastasi ossee < 28 giorni prima della randomizzazione.
    5.Anamnesi di disfunzione surrenale.
    6.Non è consentito l’uso a lungo termine di corticosteroidi somministrati in modo sistemico (>5 mg di prednisone o equivalente) durante lo studio. Sono consentiti l’uso a breve termine (<=4 settimane, compresa la diminuzione graduale della dose) e gli steroidi somministrati localmente (ad es., inalati, topici, oftalmici ed intraarticolari), se clinicamente indicati.
    7.Tumori maligni attivi (ovvero, progressione o necessità di modifica del trattamento negli ultimi 24 mesi) diversi dalla malattia trattata nello studio. Le uniche eccezioni consentite sono:
    a. carcinoma vescicale non muscolo invasivo;
    b. tumore della pelle (non melanoma o melanoma) trattato negli ultimi 24 mesi che è considerato completamente curato;
    c. carcinoma mammario – carcinoma lobulare adeguatamente trattato in situ o carcinoma duttale in situ;
    d. tumore maligno considerato guarito con un rischio minimo di recidiva.
    8.Anamnesi o diagnosi attuale di MDS/AML.
    9.Evidenza attuale nei 6 mesi precedenti la randomizzazione di una delle seguenti condizioni: angina grave/instabile, infarto miocardico, insufficienza cardiaca congestizia sintomatica, eventi tromboembolici arteriosi o venosi clinicamente significativi (ad es. embolia polmonare) o aritmie ventricolari clinicamente significative.
    10.Presenza di ipertensione incontrollata sostenuta (pressione sanguigna sistolica >160 mm Hg o pressione sanguigna diastolica >100 mm Hg). I pazienti con anamnesi di ipertensione sono ammessi, a condizione che la pressione sanguigna sia controllata entro questi limiti da un trattamento antipertensivo.
    11.Note allergie, ipersensibilità o intolleranza agli eccipienti di niraparib, AA o niraparib/AA FDC (fare riferimento all’IB per niraparib e AA).
    12.Evidenza attuale di qualsiasi condizione medica che renderebbe controindicato l’uso di prednisone.
    13.Aver ricevuto un intervento sperimentale (compresi i vaccini sperimentali) o aver utilizzato un dispositivo medico sperimentale invasivo nei 30 giorni precedenti la prima dose programmata del farmaco dello studio.
    14.Pazienti che hanno manifestato quanto segue <=28 giorni prima della randomizzazione:
    a. una trasfusione (piastrine o globuli rossi);
    b. Fattori di crescita ematopoietici;
    c. Intervento di chirurgia maggiore (deve essere consultato lo sponsor riguardo a ciò che costituisce un intervento di chirurgia maggiore).
    15.Noto virus dell’epatite B attivo (ad es., reattivo all’antigene di superficie dell’epatite B) o virus dell’epatite C attivo (HCV; ad es., acido ribonucleico dell’HCV [RNA] [qualitativo]).
    E.5 End points
    E.5.1Primary end point(s)
    Radiographic progression-free survival (rPFS)
    Sopravvivenza libera da progressione radiografica (rPFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    While on study treatment, radiographic imaging will be performed every 8 weeks for the first 6 months and every 12 weeks thereafter
    Durante il trattamento in studio, l'imaging radiografico verrà eseguito ogni 8 settimane per i primi 6 mesi e successivamente ogni 12 settimane
    E.5.2Secondary end point(s)
    * OS
    * Symptomatic progression-free survival
    * Time to subsequent therapy
    * OS
    * Sopravvivenza libera da progressione sintomatica
    * Tempo alla terapia successiva
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessments of the secondary endpoints are variable but carried out on a regular basis throughout study as described in the endpoint requirements
    Le valutazioni degli endpoint secondari sono variabili ma vengono eseguite regolarmente durante lo studio come descritto nei requisiti degli endpoint
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA150
    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
    Belarus
    Brazil
    Canada
    China
    Israel
    Korea, Republic of
    Malaysia
    Mexico
    Moldova, Republic of
    New Zealand
    Russian Federation
    South Africa
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    Belgium
    Bulgaria
    Denmark
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    Sweden
    United Kingdom
    Czechia
    Argentina
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    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 months11
    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 months6
    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: 252
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 536
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 788
    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)
    Protocol Section 6.6: In the event of early completion or study termination by the sponsor, participants who are clinically benefiting from the study medication will be provided with study medication until disease progression, unacceptable toxicity, or an alternate method is in place to avoid treatment interruption. During this time, an abbreviated schedule of study-related procedures will be performed and limited data collected; details will be provided at a later date.
    Prot. Sez. 6.6: In caso di completamento anticipato o di interruzione dello studio dallo sponsor, ai partecipanti che stanno clinicamente beneficiando del farmaco in studio verrà fornito il farmaco in studio fino a progressione della malattia, tossicità inaccettabile o fino a quando non vi sarà un metodo alternativo per evitare l'interruzione del trattamento . In questo periodo, verranno ridotte le procedure di studio e verranno raccolti dati limitati; i dett. saranno forniti in un 2’ momento.
    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 Decision2020-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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