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Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43936   clinical trials with a EudraCT protocol, of which   7310   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2017-003552-23
    Sponsor's Protocol Code Number:64091742PCR2002
    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:2021-06-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-003552-23
    A.3Full title of the trial
    A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
    Uno studio di fase 1b-2 delle terapie di associazione con niraparib per il trattamento del cancro prostatico resistente alla castrazione metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the tolerability, safety and anti-tumor effect of Niraparib in combination with different anticancer agents in men with metastatic castration-resistant prostate cancer (mCRPC)
    Uno studio per valutare la tollerabilità, la sicurezza e l'effetto antitumorale di Niraparib in combinazione con diversi agenti antitumorali negli uomini con carcinoma prostatico resistente alla castrazione metastatico (mCRPC)
    A.3.2Name or abbreviated title of the trial where available
    QUEST
    QUEST
    A.4.1Sponsor's protocol code number64091742PCR2002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03431350
    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 CILAG INTERNATIONALE NV
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportJANSSEN CILAG SPA
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    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 number5242166
    B.5.5Fax number5242110
    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 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 nameCetrelimab
    D.3.2Product code [JNJ-63723283]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCetrelimab
    D.3.9.2Current sponsor codeJNJ-63723283
    D.3.9.4EV Substance CodeSUB183887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 nameCetrelimab
    D.3.2Product code [JNJ-63723283]
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCetrelimab
    D.3.9.2Current sponsor codeJNJ-63723283
    D.3.9.4EV Substance CodeSUB183887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 100mg capsule
    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.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 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]
    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 INNabiraterone acetato
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor code154229-18-2
    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: 5
    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 Prednisone acis®
    D.2.1.1.2Name of the Marketing Authorisation holderacis Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePrednisone acis® 5 mg tablets
    D.3.2Product code [Prednisone]
    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 INNPREDNISONE
    D.3.9.2Current sponsor codePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 6
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeJNJ-64091742
    D.3.9.3Other descriptive nameD.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 INNabiraterone acetato
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor codeABIRATERONE ACETATE
    D.3.9.3Other descriptive nameD.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: 7
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeJNJ-64091742
    D.3.9.3Other descriptive nameD.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 INNabiraterone acetato
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor codeABIRATERONE ACETATE
    D.3.9.3Other descriptive nameD.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: 8
    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/ 500 mg (G012)
    D.3.2Product code [CJNJ-67652000-G012]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeJNJ-64091742
    D.3.9.3Other descriptive nameD.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 INNabiraterone acetato
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor codeABIRATERONE ACETATE
    D.3.9.3Other descriptive nameD.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: 9
    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/ 500 mg (G014)
    D.3.2Product code [CJNJ-67652000-G014]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeJNJ-64091742
    D.3.9.3Other descriptive nameD.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 INNabiraterone acetato
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor codeABIRATERONE ACETATE
    D.3.9.3Other descriptive nameD.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.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
    Metastatic castration-resistant prostate cancer (mCRPC)
    tumore alla prostata metastatico resistente alla castrazione
    E.1.1.1Medical condition in easily understood language
    Metastatic castration-resistant prostate cancer (mCRPC)
    tumore alla prostata metastatico resistente alla castrazione
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    Part 1:
    - To evaluate the tolerability of niraparib combination therapies for the treatment of mCRPC
    - Determine the recommended Phase 2 dose (RP2D) of niraparib combination therapies

    Part 2 (Dose Expansion):
    - To evaluate the antitumor effect of the RP2D of niraparib combination therapies for treatment of mCRPC
    - To evaluate the safety of the RP2D of niraparib combination therapies for the treatment of mCRPC

    For Combination 3:
    -To determine the relative bioavailability of 2 regular strength FDC tablet formulations of niraparib and AA with respect to niraparib and AA coadministered as SA under fasted conditions in subjects with mCRPC
    Parte 1:
    1.Valutare la tollerabilità delle terapie di associazione con niraparib per il trattamento di mCRPC
    2.Determinare il RP2D delle terapie di associazione con niraparib

    Parte2:
    1.Valutare l’effetto antitumorale della RP2D nelle terapie di associazione con niraparib per il trattamento di mCRPC
    2.Valutare la sicurezza della RP2D nelle terapie di associazione con niraparib per il trattamento di mCRPC

    Per Combinazione 3:
    Determinare la biodisponibilità relativa di 2 formulazioni FDC in compresse a dosaggio regolare di niraparib e AA, rispetto a niraparib e AA co-somministrati come singoli agenti (SA) in condizioni di digiuno in soggetti con mCRPC
    E.2.2Secondary objectives of the trial
    Part 1:
    - To characterize the pharmacokinetics (PK) and immunogenicity (if applicable) of niraparib combination therapies
    Part 2:
    - To evaluate other response outcomes of niraparib combination therapies for the treatment of mCRPC
    - To evaluate duration of response
    - To characterize the PK and immunogenicity (if applicable) of niraparib combination therapies through sparse sampling

    For Combination 3:
    -To evaluate the PK of a low-strength FDC tablet formulations of niraparib and AA under fasted conditions in subjects with mCRPC
    -To assess the safety of niraparib in combination with AA in subjects with mCRPC
    Part 1:
    - caratterizzare farmacocinetica (PK) e immugeneticità (se applicabile) delle terapie in combinazione con niraparib
    Part 2:
    - valutare altri risultati di risposta delle terapie combinate di niraparib per il trattamento di mCRPC
    - valutare la durata della risposta
    - Caratterizzare la PK e l'immunogenicità (se applicabile) delle terapie combinate di niraparib attraverso il campionamento sparso

    Per Combinazione 3:
    -Valutare la PK di formulazioni FDC in compresse a ridotto dosaggio di niraparib e AA in condizioni di digiuno in soggetti con mCRPC
    -Valutare la sicurezza di niraparib in combinazione con AA in soggetti con mCRPC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 years of age or older
    2. Willing to undergo all protocol-specified biopsies
    3. Diagnosis of prostate adenocarcinoma as confirmed by the investigator.
    4. Criterion moved per Amendment 3.
    5. Criterion moved per Amendment 3
    6. Criterion moved per Amendment 3
    7. Must have castrate levels of testosterone =50 ng/dL on a gonadotropin releasing hormone analogue (GnRHa), or history of bilateral orchiectomy at study entry
    8. Progression of metastatic prostate cancer at study entry defined as having one or more of the following:
    a. PSA progression defined by a minimum of 2 rising PSA levels with an interval of =1 week between each determination (per Prostate Cancer Working Group 3 [PCWG3] criteria). The PSA level at the screening visit should be =2 µg/L (2 ng/mL).
    b. Radiographic progression by bone scan per PCWG3 or by soft tissue per RECIST 1.1
    9. Must be willing to continue GnRHa during the study if not surgically castrate.
    10. Eastern Cooperative Oncology Group Performance Score (ECOG PS) Grade of 0 or 1
    11. Subjects who received prior therapy with an anti-androgen (eg, bicalutamide, flutamide, nilutamide, enzalutamide, apalutamide) must have at least a 4-week wash-out prior to enrollment.
    12. Criterion modified per Amendment 6.
    12.1 While on study medication and for 3 months (Combination 2) or 5 months (Combination 1) following the last dose of study medication, a male subject must agree to use an adequate contraception method as deemed appropriate by the investigator and as specified in Section 4.4 Lifestyle Considerations.
    13. Clinical laboratory values at Screening:
    a.Absolute neutrophil count (ANC) =1.5 x 10^9/L, independent of growth factors for 30 days
    b.Hemoglobin =9.0 g/dL, independent of growth factors or transfusions for 30 days
    c.Platelet count =100 x 10^9/L, independent of growth factors or transfusions for 30 days
    d.Serum albumin =3.0 g/dL
    e.Creatinine clearance =30 mL/min/1.73 m^2 either calculated or directly measured via 24-hour urine collection
    f.Serum total bilirubin =1.5 x upper limit of normal (ULN) or direct bilirubin =1 x ULN (Note: in subjects with Gilbert’s syndrome, if total bilirubin is >1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is =1.5 x ULN, subject may be eligible as determined by the medical monitor)
    g.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3 x ULN
    h.Fasting glucose =250 mg/dL
    14.A male subject must agree not to donate sperm while on study treatment and for 3 months (Combination 2) or 5 months (Combination 1) following the last dose of study medication.
    Combination 1: Niraparib and Cetrelimab
    1. Criterion modified per Amendment 4.
    1.1. Must have determination of biomarker positive for DRD or CDK12 (biallelic) by the sponsor's blood or tissue assay. For Part 1 of the study, subjects can be dosed prior to assay results becoming available. Results are required prior to dosing for Part 2.
    2. Subjects must have measurable disease as defined by RECIST 1.1 (soft tissue lesion of =10mm in the long axis or extrapelvic lymph node of =15mm in the short axis).
    3. Must have previously received at least 1, but no more than 2, lines of novel AR-targeted therapy (ie, abiraterone acetate with prednisone, enzalutamide) for mCRPC. Subjects must have had at least 4 weeks of AR-targeted therapy.

    Combination 2: Niraparib and AAP
    1. Must be biomarker positive for DRD by either blood or tissue assay
    2. Must have progressed on 1 prior line of novel AR-targeted therapy (ie, abiraterone acetate with prednisone, enzalutamide) for mCRPC. Prior treatment with taxane-based therapy and AR-targeted therapy outside of the mCRPC setting are allowed.

    Combination 3:
    In the protocol please See Attachment 6 for the Inclusion Criteria for Combination 3.
    1 Almeno 18 anni di età.
    2. Intenzione di sottoporsi a tutte le biopsie specifiche del protocollo.
    3. La diagnosi di adenocarcinoma alla prostata deve essere confermata dallo sperimentatore.
    4. Criterio spostato nella sezione 4.2.1 tramite emendamento 3.
    5. Criterio spostato nella sezione 4.2.1 tramite emendamento 3.
    6. Criterio spostato nella sezione 4.2.1 tramite emendamento 3.
    7. Livelli di testosterone dopo castrazione = 50 ng/dl di un analogo dell’ormone di rilascio delle gonadotropine (GnRHa) oppure storia di orchiectomia bilaterale
    all’ingresso nello studio.
    8. Progressione del cancro prostatico metastatico all’ingresso nello studio, definita come presenza di una o più delle condizioni seguenti:
    a. Progressione PSA definita tramite almeno 2 livelli PSA in aumento con un intervallo =1 settimana tra ogni rilevazione (secondo i criteri del Prostate Cancer Working Group 3 [PCWG3]).45 Il livello di PSA alla visita di screening deve essere =2 µg/l (2 ng/ml).
    b. Progressione radiografica tramite scintigrafia secondo PCWG3 o tramite tessuti molli secondo RECIST 1.1.7,45
    9. Intenzione di proseguire l’assunzione di GnRHa durante lo studio per i soggetti non sottoposti a castrazione chirurgica.
    10. Punteggio di prestazione dell’Eastern Cooperative Oncology Group (PS ECOG) di grado 0 o 1 (vedere allegato 2).
    11. Criterio modificato con l’emendamento 3.
    11.1 I soggetti che hanno ricevuto una precedente terapia con un anti-androgeno (ad es. bicalutamide, flutamide, nilutamide, enzalutamide, apalutamide) devono attendere un washout di almeno 4 settimane prima dell’arruolamento.
    12. Criterio modificato con l’emendamento 6.
    12.1 Durante il trattamento con farmaci in studio e per 3 mesi (Combinazione 2) o 5 mesi (Combinazione 1) dopo l'ultima dose di farmaco in studio, un soggetto maschio deve accettare di utilizzare un adeguato metodo contraccettivo ritenuto appropriato dallo sperimentatore e come specificato nella sezione 4.4 (Considerazioni sullo stile di vita).
    13. Criterio modificato con l’emendamento 2.
    13.1 Valori clinici di laboratorio allo screening:
    a. Conta assoluta dei neutrofili (ANC) =1.5 x 109/l, indipendentemente dai fattori di crescita per 30 giorni
    b. Emoglobina =9,0 g/dl, indipendentemente da fattori di crescita o trasfusioni per 30 giorni
    c. Conta piastrinica =100 x 109/l, indipendentemente da fattori di crescita o trasfusioni per 30 giorni
    d. Albumina sierica =3,0 g/dl
    e. Clearance della creatinina =30 ml/min/1,73 m2 calcolata o misurata direttamente con raccolta delle urine nelle 24 ore
    f. Bilirubina totale nel siero =1,5 x limite superiore della norma (ULN) oppure bilirubina diretta =1 x ULN (nota: nei soggetti affetti da sindrome di Gilbert, se la bilirubina totale è >1,5 x ULN, occorre misurare la bilirubina diretta e
    indiretta; se la bilirubina diretta è =1,5 x ULN, i soggetti possono essere idonei secondo il giudizio del monitor medico)
    g. Aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) =3 x ULN
    h. Glucosio a digiuno =250 mg/dl
    14. Un soggetto maschio deve accettare di non donare sperma durante il trattamento in studio e per 3 mesi (Combinazione 2) o 5 mesi (Combinazione 1) dopo l'ultima dose del farmaco di studio.
    Combinazione 1: niraparib e JNJ-63723283 (nap per Italia).Vedere sotto parte in inglese
    Combinazione 2: niraparib e AA-P
    In aggiunta ai criteri di cui in 4.2, ciascun potenziale soggetto per la Combinazione 2 deve
    soddisfare i criteri seguenti:
    1. Positività ai biomarcatori per DRD dimostrata mediante analisi di sangue o tessuto ad opera dello sponsor.
    2. Progressione dopo 1 linea precedente di nuova terapia androgeno-soppressiva (AR) (ad es. abiraterone acetato con prednisone, enzalutamide) per mCRPC. Un precedentetrattamento con terapia a base di taxani e terapia androgeno-soppressiva (AR) al di fuori del contesto mCRPC è ammesso.
    Combinazione 3:
    Nel protocollo vedere l'Allegato 6 per i criteri di inclusione per la combinazione 3.
    E.4Principal exclusion criteria
    1. Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor.
    2. History or current diagnosis of (MDS)/ (AML).
    3. Criterion modified per Amendment 5. 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 please refer to protocol.
    4. Active infection requiring systemic therapy.
    5. Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients (refer to the Investigator’s Brochures).
    6. Human immunodeficiency virus (HIV)-positive subjects with 1 or more of the following:
    a. Not receiving highly active antiretroviral therapy.
    b. A change in antiretroviral therapy within 6 months of the start of screening (except if, after consultation with the sponsor on exclusion criterion 11.c, a change is made to avoid a potential drug-drug interaction with the study drug).
    c. Receiving antiretroviral therapy that may interfere with the study drug
    (consult the sponsor for review of medication prior to enrollment).
    d. CD4 count <350 cells/mm^3 at screening.
    e. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening.
    7. Active hepatitis B virus (eg, hepatitis B surface antigen reactive) or active hepatitis C virus (HCV) (eg, HCV ribonucleic acid [RNA] [qualitative] is detected).
    8. If a subject has undergone major surgery, they must have recovered adequately from the toxicities or complications from the intervention prior to starting therapy.
    9. Criterion deleted per Amendment 2
    10. Any of the following =30 days prior to planned Cycle 1 Day 1:
    a.A transfusion (platelets or red blood cells).
    b.Hematopoietic growth factors.
    c.An investigational agent for prostate cancer.
    d.Major surgery (sponsor's medical monitor should be consulted regarding what constitutes major surgery).
    e.Radiation therapy
    For other criterias please see the protocol.
    For excl.criteria to comb. 1: Niraparib and Cetrelimab:
    1. Criterion deleted per Amendment 2
    2. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody (including any antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
    3. Subjects with a history of allergy to protein-based therapies or any significant drug allergy (ie, anaphylaxis, heptatotoxicity, or immune-mediated thrombocytopenia or anemia).
    4. History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis.
    5. Allergies, hypersensitivity, or intolerance to Cetrelimab or the corresponding excipients (refer to the Investigator’s Brochure).
    6. Immunodeficiency or receiving systemic corticosteroid therapy or immunosuppressive therapy (eg, cyclosporine) within 7 days prior to treatment allocation. The use of physiologic doses of corticosteroids may be approved after consultation with the
    sponsor.
    7. Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
    Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
    8. Received a live vaccine within 30 days of the first dose of study drugs.
    9. History of organ transplant, including allogeneic stem cell transplantation.
    Comb. 2: Niraparib and AAP
    1. Allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or the corresponding excipients (refer to the Investigator’s Brochure)
    2. Current evidence of any of the following:
    a. Any medical condition that would make prednisone use contraindicated.
    b. Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone (or equivalent) once daily
    Lifestyle Considerations: section 4.4
    Comb. 3:
    No additional Exclusion criteria. Refer to the Exclusion criteria listed for Combinations 1 and 2.
    I criteri di esclusione specifici per associazione sono riportati nelle apposite sottosezioni di seguito. I potenziali soggetti in possesso di uno qualsiasi dei criteri seguenti saranno esclusi dalla partecipazione allo studio:
    1. Precedente trattamento con un PARP-inibitore.
    2. Storia o diagnosi corrente di MDS/AML.
    3. Criterio modificato in base all'eme. 5. Neoplasie attive (cioè, in progressione o che richiedono una modifica del trattamento negli ultimi 24 mesi) diversa dalla malattia in corso di studio. Per le uniche eccezioni consentite fare riferimento al protocollo.
    4. Infezione attiva che richiede la terapia sistemica.
    5. Allergie, ipersensibilità o intolleranza a niraparib o ai relativi eccipienti (consultare ildossier dello sperimentatore).
    6. Soggetti positivi al virus dell’immunodeficienza umana (HIV) con 1 o più delle caratteristiche seguenti:
    a. Mancata assunzione di una terapia antiretrovirale altamente attiva.
    b. Una variazione della terapia antiretrovirale nei 6 mesi precedenti all'inizio dello screening (eccetto se, dopo un consulto con lo sponsor sul criterio di esclusione 11.c, la modifica è apportata allo scopo di evitare una potenziale interazione farmaco-farmaco con il farmaco sperimentale).
    c. Assunzione di una terapia antiretrovirale che potrebbe interferire con il farmaco dello studio (consultare lo sponsor per l’esame dei farmaci prima dell’arruolamento).
    d. Conta CD4 <350 cellule/mm3 allo screening.
    e. Un’infezione opportunistica per definizione della sindrome da immunodeficienza acquisita nei 6 mesi precedenti all’inizio dello screening.
    7. Virus dell'epatite B attivo (ad es. antigene di superficie dell’epatite B reattivo) o virus dell’epatite C attivo (HCV) (ad es. rilevamento di acido ribonucleico (RNA) dell'HCV [qualitativo]).
    8. Se un soggetto è stato sottoposto a un intervento di chirurgia maggiore, deve essersiripreso adeguatamente dalle tossicità o da complicazioni legate all’intervento prima dell’inizio della terapia.
    9. Criterio eliminato per eme. 2.
    10. Uno degli eventi indicati di seguito =30 prima del previsto Giorno 1 del Ciclo 1:
    a. Una trasfusione (piastrine o globuli rossi).
    b. Fattori di crescita ematopoietici.
    c. Un agente sperimentale per il carcinoma prostatico.
    d. Un intervento di chirurgia maggiore (il monitor medico dello sponsor deve essere consultato in merito alla definizione di chirurgia maggiore).
    e. Radioterapia.
    11. Metastasi cerebrale sintomatica del cancro prostatico.
    12. Criterio modificato con l’eme. 3.
    12.1 Insufficienza cardiaca congestizia sintomatica (malattia cardiaca di classe III o IV secondo la New York Heart Association), angina pectoris instabile, aritmia cardiaca o ipertensione incontrollata definita come pressione sanguigna sistolica [BP] >160 mmHg o diastolica BP >100 mmHg). I soggetti con storia di ipertensione sono ammessi se la pressione è controllata entro questi limiti da una terapia antipertensiva.
    13. Presenza di qualsiasi condizione per cui, secondo il giudizio dello sperimentatore o del monitor medico, la partecipazione non sarebbe nel miglior interesse del soggetto (ad es. ne comprometterebbe il benessere) o potrebbe impedire, limitare o confondere le valutazioni specificate dal prot.
    Comb. 1: niraparib e Cetrelimab (vedere parte in inglese)
    Comb. 2: niraparib e AA-P
    Oltre ai criteri di esclusione di cui in 4.3, i criteri indicati di seguito, se soddisfatti, determinano l'esclusione del potenziale soggetto dalla Combinazione 2:
    1. Allergie, ipersensibilità o intolleranza ad abiraterone acetato o prednisone o ai relativi eccipienti (consultare il dossier dello sperimentatore).
    2. Evidenza di uno dei seguenti eventi:
    a. Qualsiasi condizione medica che renderebbe controindicato l’uso del prednisone.
    b. Qualsiasi condizione medica cronica che richieda una dose di corticosteroidi superiore a una dose di 10 mg di prednisone (o equivalente) una volta al giorno.
    Considerazioni sullo stile di vita: sezione 4.4
    Comb. 3:
    No criterio di eclusione agg.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1:
    1. Incidence of specified toxicities
    Part 2:
    Combination 1
    2. Objective response rate (ORR) of soft tissue (visceral or nodal disease)
    Combination 2
    3. Composite response rate (RR) defined as 1 of the following by PCWG3
    a. Objective Response
    b. Circulating tumor cells (CTC) response
    c. Prostate-specific antigen (PSA) decline of =50%, measured twice 3 to 4 weeks apart
    Combinations 1 and 2
    4. Incidence and severity of Adverse events (AEs)

    For Combination 3:
    1.PK parameters (Cmax, [Cmax/dose]niraparib, AUC0-168h, [AUC0 168h/dose]niraparib) of niraparib and AA after a single dose
    Parte 1:
    Incidenza di tossicità specifiche
    Parte 2:
    Combinazione 1: tasso di risposta oggettiva (ORR) dei tessuti molli (malattia viscerale o nodale) definito tramite RECIST 1.1 senza evidenza di progressione ossea in base ai criteri PCWG3
    -Combianzione 2: tasso di risposta composita (RR): definito in uno dei seguenti modi tramite PCWG3:45
    -risposta oggettiva (confermata mediante RECIST 1.1) oppure
    -risposta CTC: definita come CTC=0 per 7,5 ml di sangue a 8 settimane per soggetti con CTC =1 alla baseline o CTC<5 per 7,5 ml con CTC =5 alla baseline, confermata da un secondo valore consecutivo ottenuto 4 o più settimane più tardi, oppure
    - diminuzione dell'antigene prostatico specifico (PSA) del =50%, misurato due volte da 3 a 4 settimane di distanza
    - Incidenza e gravità degli AE
    Per combinazione 3:
    1.Parametri di PK (Cmax, [Cmax/dose]niraparib, AUC0-168h, [AUC0-168h/dose]niraparib) di niraparib e AA dopo una singola dose
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. First 28 days of treatment (Cycle 1)
    2. From Cycle (C) 1 Day (D) 1, imaging will be performed every 8 weeks for the first 6 months and then every 12 weeks thereafter
    3.
    a. At the discretion of the investigator according to routine practice
    b. At the discretion of the investigator according to routine practice
    c. At the discretion of the investigator according to routine practice
    4. Day 0 to until the End-of-treatment (EOT) visit
    Combination 3:
    1.PK samples will be taken at Predose ,30 min, 1 hr, 1.5 hrs, 2 hrs, 3 hr, 4 hrs, 6 hrs, 8 hr, 10 hr, 24 hrs, 48 hrs, 72 hrs, 168 hrs after administration.
    1. Primi 28 giorni di trattamento (Cycle 1)
    2. Dal Cycle (C) 1 Day (D) 1: le immagini saranno effettuate ogni 8 settimane per i primi 6 mesi e poi ogni 12 settimane per il periodo successivo
    3.
    a. A discrezione dello Sperimentatore in acoordo alla pratica clinica
    b. A discrezione dello Sperimentatore in acoordo alla pratica clinica
    c. A discrezione dello Sperimentatore in acoordo alla pratica clinica
    4. Al giorno 0 fino alla visita di fine trattamento (EOT)

    Combinazione 3:
    1.PK campioni saranno prelevati a Predose, 30 min, 1 ora, 1,5 ore, 2 ore, 3 ore, 4 ore, 6 ore, 8 ore, 10 ore, 24 ore, 48 ore, 72 ore, 168 ore dopo somministrazione.
    E.5.2Secondary end point(s)
    Part 1:
    1. Plasma concentrations of niraparib and, if performed, its major metabolite (M1), and plasma or serum concentrations of the combination agent
    2. Population PK parameters and derived exposure of niraparib and combination agent
    3. Anti-drug antibodies (if applicable)
    Part 2:
    Combination 1 and 2
    4. Circulating tumor cell (CTC) response
    Combination 1 only
    5. Composite Response rate (RR)
    Combination 1 and 2
    6. Duration of objective response
    7. Overall survival (OS)
    Combination 1 only
    8. Plasma concentrations of niraparib and, if performed, its major metabolite (M1) when dosed with combination agent
    9. Population PK parameters and derived exposure of niraparib and combination agent
    10. Anti-drug antibodies (if applicable)
    Combination 2 only
    11. Objective response rate (ORR) of soft tissue (visceral or nodal disease)
    For Combination 3:
    1.PK parameters (Cmax, [Cmax/dose]niraparib, AUC0-168h, [AUC0 168h/dose]niraparib) of niraparib and AA after a single dose
    2.Adverse events and clinical laboratory safety
    1. Concentrazioni plasmatiche di niraparib e, se eseguito, il suo maggiore
    metabolita (M1) e concentrazioni plasmatiche o sieriche del farmaco in associazione
    2. Parametri PK della popolazione ed esposizione derivata di niraparib e
    Il farmaco in associazione
    3. Anticorpi contro il farmaco (se applicabile)
    Parte 2:
    Combinazione 1 e 2
    4. Risposta delle cellule tumorali circolanti (CTC)
    Solo Combinazione 1
    5. Tasso di risposta composito (RR)
    Combinazione 1 e 2
    6. Durata della risposta obiettiva
    7. Sopravvivenza totale (OS)
    Solo Combinazione 1
    8. Concentrazioni plasmatiche di niraparib e, se eseguita, il suo maggiore
    metabolita (M1) quando dosato con il farmaco in associazione
    9. Parametri PK della popolazione e esposizione derivata di niraparib e
    Il farmaco in associazione
    10. Anticorpi contro il farmaco (se applicabile)
    Solo combinazione 2
    11. Tasso di risposta obiettiva (ORR) dei tessuti molli (malattia viscerale o nodale)
    Per combinazione 3:
    1.Parametri di PK (Cmax, [Cmax/dose]niraparib, AUC0-168h, [AUC0-168h/dose]niraparib) di niraparib e AA dopo una singola dose
    2.Eventi avversi e dati di sicurezza da analisi cliniche
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 8 and 9. Cycle (C) 1 Day (D) 1, C2 D1, C3 D1, C6 D1 and C12 D1
    3 and 10. Cycle 1 (D1, 15), C2 (D1, 15), C3 (D1, 15), C4 (D1, 15), C5 (D1, 15), C6 (D1, 15), C7 (D1, 15), C9 D1, C10 D1, C12 (D1, 15), at end of treatment (EoT) visit and follow-up
    4. Combination 1: At Screening and At every cycle from C 2 D 1 through C 12 D 1, and at the EoT visit.
    Combination 2: At the discretion of the investigator according to routine practice 5 & 7. Day 1 to until death.
    6. Combination 1: Day 1 to until death.
    Combination 2: At the discretion of the investigator according to routine practice.
    11. At the discretion of the investigator according to routine practice.
    For Combination 3:
    1.PK samples will be taken as per protocol
    2.Day 0 to until the End-of-Treatment (EoT) visit
    1, 2, 8 e 9. Ciclo (C) 1 giorno (D) 1, C2 D1, C3 D1, C6 D1 e C12 D1
    3 e 10. ciclo 1 (D1, 15), C2 (D1, 15), C3 (D1, 15), C4 (D1, 15), C5 (D1, 15), C6 (D1, 15), C7 (D1, 15), C9 D1, C10 D1, C12 (D1, 15), visita (EoT) e di follow-up
    4. Combinazione 1: Allo screening e ed ogni ciclo dal C 2 D al C 12 D 1, e alla visita di EoT
    Combinazione 2: A discrezione dello Sperimentatore in accordo alla pratica clinica 5 & 7. Giorno 1 fino al decesso.
    6 Combinazione 1: Giorno 1 fino al decesso.
    Combinazione 2: A discrezione dello Sperimentatore in accordo alla pratica clinica.
    11. A discrezione dello Sperimentatore in accordo alla pratica clinica.
    Per la combinazione 3:
    1.I campioni 1.PK saranno raccolti come da protocollo
    2.Giorno 0 fino alla visita di fine trattamento (EoT)
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and Biomarker Analyses
    Immunogeneticità e analisi biomarker
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Evaluate Tolerability and determine recommended Phase 2 dose of niraparib combination therapies
    Evaluate Tolerability and determine recommended Phase 2 dose of niraparib combination therapies
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    in aperto (il sistema non permette l'inserimento del dato)
    open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Canada
    Israel
    United States
    Belgium
    France
    Italy
    Spain
    United Kingdom
    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
    Last subject last visit
    ultima visita 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 months4
    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 months4
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 140
    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)
    Subjects would be managed per their local Standard of Care or go onto other research studies.
    I soggetti saranno seguiti con lo standar of care o entreranno a far parte di altri studi di ricerca
    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 Decision2019-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-17
    P. End of Trial
    P.End of Trial StatusOngoing
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