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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2016-002057-38
    Sponsor's Protocol Code Number:64091742PCR2001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-02
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-002057-38
    A.3Full title of the trial
    A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to understand the effect of Niraparib in men with end-stage PCA+
    A.4.1Sponsor's protocol code number64091742PCR2001
    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 N.V.
    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.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.5.6E-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 name Niraparib 100 mg capsules
    D.3.2Product code JNJ-64091742
    D.3.4Pharmaceutical form Capsule
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    mCRPC and DNA-repair anomalies
    E.1.1.1Medical condition in easily understood language
    Prostate cancer in adult men that has spread to other parts of the body
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of niraparib in subjects with measurable mCRPC and who have either biallelic DNA-repair anomalies in BRCA (BRCA1 or BRCA2) or germline BRCA
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of niraparib in subjects with measurable mCRPC and DNA-repair anomalies in biallelic non-BRCA (ATM FANCA, PALB2, CHEK2, BRIP1, or HDAC2)
    -To assess the efficacy of niraparib in subjects with mCRPC and DNA repair anomalies
    -To evaluate response outcomes of niraparib in subjects with mCRPC and DNA-repair anomalies
    -To evaluate the safety and tolerability of niraparib
    -To evaluate duration of tumor response
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male
    2. >18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
    3. Signed main study ICF indicating that the subject understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    4. Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which to be excluded).
    5.3. Criterion modified per Amendment 6.
    5.4. Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer with evidence of disease progression on or after treatment, or discontinued from a taxane-based chemotherapy due to an adverse event.
    6.4. Criterion modified per Amendment 7.
    6.5. Received a second-generation or later AR-targeted therapy (for example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the treatment of metastatic prostate cancer with evidence of disease progression or non-metastatic castration-resistant prostate cancer with evidence of subsequent metastasis.
    7.1. Criterion modified per Amendment 7
    7.2 Biomarker- positive by at least one of the following criteria:
    a. Biallelic DNA-repair anomaly (refer to Table 5) based on a sponsor-validated blood or tissue assay.
    b. Germline pathogenic BRCA1 or BRCA2 by any test (somatic local results must be confirmed as positive by the sponsor-validated assay before dosing).
    8. Progression of metastatic prostate cancer in the setting of castrate levels of testosterone ≤50 ng/dL on a gonadotropin releasing hormone analog (GnRHa), or history of bilateral orchiectomy 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 ≥1 μg/L (1 ng/mL).
    b. Radiographic progression of soft tissue by RECIST 1.1 or bone disease by PCWG3 criteria as defined below:
    I. Soft tissue disease measurable by RECIST defined as having one or more of the following:
    i. Nodal disease (pelvic or extrapelvic [retroperitoneal, mediastinal, thoracic, other]) with lesions ≥1.5 cm in the short axis.
    ii. Visceral disease (lung, liver, adrenal) with lesions ≥1 in the long axis.
    II. Bone disease (non-measurable) defined as having bone lesions in the absence of measurable soft tissue disease
    9. Must be able to continue GnRHa during the course of the study if not surgically castrate.
    10. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤2.
    11. Must be able to swallow whole capsules.
    12. Subject must agree to use medically accepted and highly effective methods of contraception during the course of the study and for 3 months after the last dose of study drug.
    13. To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must agree while on study drug and for 3 months following the last dose of study drug to:
    a. Use a condom during sexual activity.
    b. Not donate sperm.
    14.3. Criterion modified per Amendment 6.
    14.4. At screening, the following laboratory parameters must be met:
    a. Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
    b. Hemoglobin ≥9.0 g/dL
    c. Platelet count ≥100 x 10^9/L
    d. Serum albumin ≥3 g/dL
    e. Creatinine clearance ≥30 mL/min.
    f. Criterion deleted per Amendment 5.
    g. 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 direct bilirubin is ≤1.5 x ULN, subject may be eligible)
    h. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x ULN
    i. CTC count of ≥1 cells /7.5 mL blood (required only for patients with non-measurable soft tissue disease by RECIST 1.1)
    E.4Principal exclusion criteria
    1. Prior treatment with a PARP inhibitor.
    2. Prior platinum-based chemotherapy for the treatment of prostate cancer.
    3. Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
    4. Symptomatic or impending cord compression, except if subject has received definitive treatment for this and demonstrates evidence of clinically stable disease.
    5. Symptomatic brain metastases.
    6. Known allergies, hypersensitivity, or intolerance to niraparib or its excipients (refer to Investigator's Brochure).
    7. Any condition for which, in the opinion of the investigator or sponsor, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    8. Known disorder affecting gastrointestinal absorption.
    9. Active cancer (other than prostate cancer; or basal cell or squamous cell skin cancer, non-muscle invasive bladder cancer [stages pTaG1 and pTaG2], or any other cancer in situ currently in complete remission) within 2 years prior to Cycle 1 Day 1.
    10. Prior palliative radiotherapy ≤7 days prior to Cycle 1 Day 1. Radiotherapy given >7 days prior to Cycle 1 Day 1 is permitted as long as any AEs associated with radiotherapy have resolved to Grade 1 or baseline.
    11. Criterion deleted per Amendment 5
    12. Criterion deleted per Amendment 3.
    13. History of clinically significant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsades de pointes).
    14. 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 14.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 at screening
    e. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening
    15.1. Criterion modified per Amendment 6.
    15.1. ≤14 days prior to Cycle 1 Day 1 had:
    a. a transfusion (platelets or red blood cells)
    b. chemotherapy
    c. hematopoietic growth factors.
    16. Criterion deleted per Amendment 5.
    17. Subjects with uncontrolled (persistent) hypertension defined as systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg despite medical management.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) or soft tissue (visceral or nodal disease) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with no evidence of bone progression according to the PCWG3 criteria
    E.5.1.1Timepoint(s) of evaluation of this end point
    Final analysis for the RR will occur approximately 30 months (approximately 6 months from last subject enrolled)
    E.5.2Secondary end point(s)
    - Circulating tumor cell (CTC) response defined as CT=0 per 7.5 mL blood at 8 weeks post-baseline in subjects with baseline CTC >0
    OS: time from enrollment to death from any cause
    - rPFS: time from enrollment to radiographic progression or death from any cause, whichever occurs first
    -Time to radiographic progression
    -Time to PSA progression
    -Time to symptomatic skeletal event (SSE)
    -Incidence of adverse events
    -Clinical laboratory test results
    -Duration of objective response: time from complete response (CR) or partial response (PR) to radiographic progression of disease, unequivocal clinical progression, or death, whichever occurs first
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not answered
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    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) 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 Yes
    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 No
    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 trial1
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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 No
    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
    Belgium
    Brazil
    Canada
    France
    Israel
    Korea, Republic of
    Netherlands
    Russian Federation
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days26
    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: 83
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 206
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 289
    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)
    Long-term Extension Phase: The LTE Phase will begin after completion of the primary analysis and subsequent notification to the sites. The sponsor will continue to provide study drug until subjects no longer derive benefit from treatment or until further notification by the sponsor on a different means for continued supply of study treatment.
    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 Decision2016-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-16
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