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    Summary
    EudraCT Number:2015-000952-11
    Sponsor's Protocol Code Number:PR-30-5017-C
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2017-07-12
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-000952-11
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
    A.4.1Sponsor's protocol code numberPR-30-5017-C
    A.5.4Other Identifiers
    Name:IND No.Number:100,996
    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 SponsorTESARO Inc. a GSK company
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTESARO, Inc. a GSK company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTESARO, Inc. a GSK company
    B.5.2Functional name of contact pointClinical Trial Mailbox
    B.5.3 Address:
    B.5.3.1Street Address1000 Winter Street, Suite 3300
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@tesarobio.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 ZEJULA
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Ireland Ltd
    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 nameNiraparib (GSK3985771)
    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 (GSK3985771)
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeL-001946812-005R, L-001946812 and MK-4827
    D.3.9.3Other descriptive nameNIRAPARIB (GSK3985771)
    D.3.9.4EV Substance CodeSUB93448
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Homologous recombination deficiency advanced ovarian cancer
    E.1.1.1Medical condition in easily understood language
    Homologous recombination deficiency advanced ovarian cancer
    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 PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    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
    The primary objective of this study is to evaluate the efficacy of niraparib versus placebo as maintenance treatment, as measured by progression-free survival (PFS), in patients with Stage III or IV ovarian cancer (including fallopian and peritoneal cancers) with a complete response (CR) or partial response (PR) following front-line platinum-based chemotherapy treatment.
    E.2.2Secondary objectives of the trial
    • To evaluate additional measures of clinical benefit for niraparib versus placebo as maintenance treatment, such as overall survival (OS), patient-reported outcomes (PROs), time to first subsequent therapy (TFST) and time to progression on the next anticancer therapy (PFS2).
    • To evaluate the safety and tolerability of niraparib versus placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must be female ≥18 years of age, able to understand the study procedures and agree to participate in the study by providing written informed consent
    2.a. Patients must have histologically diagnosed high-grade serous or endometrioid, or high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to FIGO criteria
    Note: Patients who have received neoadjuvant chemotherapy may be included in the study if post-chemotherapy tumor grade is not evaluable
    3. Surgical criteria:
    a. Patients with inoperable Stage III and IV disease are eligible;
    b. All Stage IV patients with operable disease are eligible;
    c. Patients with stage III or IV disease treated with neoadjuvant chemotherapy and interval debulking surgery are eligible;
    d. Patients with stage III disease who have visible residual disease after primary debulking surgery are eligible .
    4. Chemotherapy criteria:
    a. Patients who have received intraperitoneal chemotherapy are eligible;
    b. All patients must have had ≥6 and ≤9 cycles of platinum-based therapy;
    c. Patients must have had ≥2 post-operative cycles of platinum-based therapy following interval debulking surgery;
    d. Patients must have physician assessed CR or PR after ≥ 3 cycles of therapy;
    e. Patients must have either CA-125 in the normal range or CA-125 decrease by more than 90% during their front-line therapy that is stable for at least 7 days (ie, no increase >15% from nadir)
    5. Patients must be randomized within 12 weeks of the first day of the last cycle of chemotherapy.
    6. All patients must agree to undergo a central tumor HRD testing.
    a. The central HRD test result must be available for randomization as it is a stratification factor. Patients with documented gBRCA1 or gBRCA2 mutation or sBRCA1/2 mutation may be randomized without HRD test results
    b. The tumor sample may be submitted for HRD testing prior to the screening period if it appears the patient is likely to meet other eligibility requirements. Patients are not required to have repeat HRD testing if HRD result is “not determined” (eg, due to insufficient tumor specimen)
    c. Patients with known HRD test results from a commercially available source are allowed to participate in the study; however, they must still agree to submit a tumor sample for central HRD testing. The results of the central HRD testing must be available prior to randomization and must be used for stratification. Additional testing related to HRD may be performed on the sample used for screening and randomization post randomization. If there is inadequate tissue remaining subsequent to the screening analysis, sites may be requested to provide additional tissue from the block used for screening purposes.
    7. Patients of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin [hCG]) within 7 days prior to receiving the first dose of study treatment
    8. Patients must be postmenopausal, free from menses for >1 year, surgically sterilized, or willing to use adequate contraception to prevent pregnancy (see Appendix A) or must agree to abstain from activities that could result in pregnancy throughout the study, starting with enrollment through 180 days after the last dose of study treatment
    9. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    10. Patients must have adequate organ function, defined as follows (Note: complete blood count [CBC] test should be obtained without transfusion or receipt of stimulating factors within 2 weeks before obtaining screening blood sample):
    a. Absolute neutrophil count ≥ 1,500/μL
    b. Platelets ≥ 100,000/μL
    c. Hemoglobin ≥ 10 g/dL
    d. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault equation
    e. Total bilirubin ≤ 1.5 x ULN
    f. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
    11. All patients must agree to complete PROs during study and then at 4 weeks, 8 weeks, 12 weeks, and 24 weeks after EOT, regardless of subsequent treatment
    12. Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary cancer or agree to undergo fresh biopsy prior to study treatment initiation
    13. Patients must be able to take oral medications
    E.4Principal exclusion criteria
    1. Patient has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer
    2. Patient with Stage III disease who have had complete cytoreduction (i.e., no visible residual disease) after primary debulking surgery
    3. Patient has undergone more than two debulking surgeries
    4. Patient is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for up to 180 days after the last dose of study treatment
    5. Patient has a known hypersensitivity to the components of niraparib or its excipients
    6. Patient is simultaneously enrolled in any clinical trial of niraparib or any other investigational therapy
    7. Patient has received prior treatment with a known PARP inhibitor or has participated in a study where any treatment arm included administration of a known PARP inhibitor
    8. Patient is to receive bevacizumab as maintenance treatment. Patients who have received bevacizumab with their first-line platinum based therapy but are unable to receive bevacizumab as maintenance therapy due to adverse events or for any other reason are not excluded from study as long as the last dose of bevacizumab was received ≥ 28 days prior to signing the main informed consent form
    9. Patient has had investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study
    10. Patient has had any known ≥Grade 3 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted >4 weeks
    11. Patient has any known history or current diagnosis of MDS or AML;
    12. Patient has undergone major surgery (per Investigator judgment) within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery;
    13. Patient has had drainage of ascites within 4 weeks prior to enrollment;
    14. Patient has undergone palliative radiotherapy encompassing >20% of the bone marrow within 1 week of the first dose of study treatment;
    15. Patient has a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the patient’s participation for the full duration of the study treatment, including:
    a. Patient received a transfusion (platelets or red blood cells) within 2 weeks of the first dose of study treatment;
    b. Patient received colony-stimulating factors (eg, granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment.
    16. Patient is planning to donate blood during the study or for 90 days after the last dose of study treatment.
    17. Patient has been diagnosed and/or treated for invasive cancer less than 5 years prior to study enrollment. Note: Patients with definitively treated uterine cervical or urinary tract carcinoma in situ, non-melanomatous skin cancer or ductal carcinoma in situ (DCIS) of the breast are not excluded.
    18. Patient has known brain or leptomeningeal metastases that are untreated or uncontrolled (ie, new or worsening symptom or signs, or unstable steroid requirements)
    19. Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
    20. Patient is immunocompromised (patients with splenectomy are allowed)
    21. Patient has known, active hepatic disease (ie, hepatitis B or C)
    22. Patient has a corrected QT interval (QTc) prolongation > 480 milliseconds at screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is PFS, defined as the time from treatment randomization to the earlier date of assessment of progression or death by any cause in the absence of progression.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of assessment of progression or death by any cause in the absence of progression.
    E.5.2Secondary end point(s)
    The secondary endpoints include the following:
    • OS
    • Observed changes from baseline in the following PROs:
    − FOSI
    − EQ-5D-5L
    − EORTC-QLQ-C30
    − EORTC-QLQ-OV28
    • Time to first subsequent therapy (TFST)
    • PFS2
    E.5.2.1Timepoint(s) of evaluation of this end point
    Per Protocol
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    - To evaluate potential biomarkers related to ovarian cancer and poly(ADP-ribose) polymerase (PARP) inhibition (e.g. DNA repair pathways)
    - To explore the relationship between HRD status and platinum sensitivity in ovarian cancer patients who have initial response to front-line platinum therapy
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA116
    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
    Switzerland
    Ukraine
    Canada
    Israel
    Russian Federation
    United Kingdom
    United States
    Belgium
    Czechia
    Denmark
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Norway
    Poland
    Spain
    Sweden
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    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: 519
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 423
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 396
    F.4.2.2In the whole clinical trial 942
    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)
    According to the clinical trial protocol (see section 3 and 7).
    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 Decision2017-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-11
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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