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    Summary
    EudraCT Number:2013-000685-11
    Sponsor's Protocol Code Number:PR-30-5011-C
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000685-11
    A.3Full title of the trial
    A Phase 3 Randomized Double-Blind Trial of Maintenance with Niraparib Versus Placebo in Patients with Platinum Sensitive Ovarian Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ND
    A.4.1Sponsor's protocol code numberPR-30-5011-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.
    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.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTESARO Inc.
    B.5.2Functional name of contact pointDebbie Myers
    B.5.3 Address:
    B.5.3.1Street Address1000 Winter Street, Suite 3300
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post code02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number13399700904
    B.5.5Fax number13394698952
    B.5.6E-maildmyers@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 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
    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 codeL-001946812-005R, L-001946812 and MK-4827
    D.3.9.3Other descriptive nameNIRAPARIB
    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
    Platinum Sensitive Ovarian Cancer
    E.1.1.1Medical condition in easily understood language
    Platinum Sensitive 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 16.0
    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 efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of PFS.
    E.2.2Secondary objectives of the trial
    (1) To bridge the centralized BRCA mutation test method to a candidate companion diagnostic test, if needed.
    (2) To evaluate additional measures of clinical benefit, including PROs, PFS2, chemotherapy-free interval (CFI) and OS.
    (3) To evaluate the safety and tolerability of niraparib compared to placebo in the indicated target population.
    (4) To evaluate QTc in a subset of niraparib-treated ovarian cancer patients.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Food effect substudy, Version 1.0, date 03-May-2013
    Objective: To assess the effect of a high fat meal on the pharmacokinetics of a single 300 mg dose
    of niraparib in patients with ovarian cancer.
    E.3Principal inclusion criteria
    1. Female, age at least 18 years
    2. Patient agrees to undergo analysis of their germline BRCA status. (Testing mustbe completed prior to randomization with sample submitted up to 3 months prior to randomization if it appears patient is likely to meet other eligibility requirements.)
    3. Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
    4. High grade (or grade 3) serous histology or known to have gBRCAmut
    5. Patients must have completed at least 2 previous courses of platinum-containing therapy (e.g. carboplatin, oxaliplatin or cisplatin):
    a. For the penultimate (next to last) platinum based chemotherapy course prior to enrollment on the study:
    i. A patient must have platinum sensitive disease after this treatment; defined as achieving a response (CR or PR) and having a chemotherapy-free interval of ≥6 months (document 6-12m or
    >12m). Chemotherapy-free interval is defined as the time from last dose of platinum until initiation of subsequent therapeutic chemotherapy (excluding maintenance therapy; source documentation required and may include physician or clinic notes)
    b. For the last chemotherapy course prior to enrollment on the study:
    i. Patients must have received a platinum-containing regimen for a minimum of 4 cycles
    ii. Patients must have achieved a partial or complete tumor response.
    iii. Following the last regimen, patients must have either
    1. CA125 in the normal range OR
    2. CA125 decrease by more than 90% during their last platinum regimen which is stable for at least 7 days (i.e., no increase >15%)
    iv. Following the last regimen, patients must have no measurable disease >2cm at the time of study entry
    c. Patients must be started on study treatment between 3 and 8 weeks after completion of their final dose of the platinum-containing regimen.
    6. The patient agrees to complete PROs during study treatment AND one additional time point 8 weeks following study treatment discontinuation. It is estimated that completion of PROs will take less than 20 minutes at each time point. Since these are questionnaires, their completion will not interfere with, or preclude, future treatment or clinical studies.
    7. Formalin fixed, paraffin embedded archival tumor available from the primary or recurrent cancer required for all non-gBRCAmut patients (and strongly encouraged for gBRCAmut patients).
    8. ECOG performance status 0-1.
    9. Adequate organ function
    a. Absolute neutrophil count (ANC) ≥1,500/mcL
    b. Platelets ≥100,000/mcL
    c. Hemoglobin ≥9g/dL
    d. Serum creatinine ≤1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥60mL/min using Cockcroft-Gault equation
    e. Total bilirubin ≤1.5x ULN OR direct bilirubin ≤ 1x ULN
    f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x ULN unless liver metastases are present, in which case they must be ≤5x ULN
    10. Able to take oral medications
    11. Women of childbearing potential must use adequate birth control for the duration of study participation.

    Additional Inclusion Criteria for Food Effect Sub Study:
    With the exception of inclusion criteria 2, 4, 5, 6, 7 and 8 (above), all main study inclusion criteria apply. In addition, the following inclusion criteria apply to the food effect sub-study only:
    1. Entry criteria are broadened to include patients with ovarian cancer regardless of platinum sensitivity and burden of disease as long as no standard therapy exists or the patient has refused standard therapy.
    2. ECOG 0-2.
    3. Must be able to eat a high-fat meal and fast for 12 hours.
    E.4Principal exclusion criteria
    1. Drainage of ascites during last 2 cycles of last chemotherapy.
    2. Palliative radiotherapy within 1 week encompassing >20% of the bone marrow.
    3. Persistent > grade 2 toxicity from prior cancer therapy.
    4. Symptomatic uncontrolled brain or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression may be considered if they have received definitive treatment for this and evidence of clinically stable disease for 28 days.
    5. Known hypersensitivity to the components of niraparib.
    6. Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery.
    7. Diagnosis, detection or treatment of invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitively treated).
    8. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
    9. History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient‘s participation for the full duration of the study treatment, or is not in the best interest of the patient to participate.
    10. Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the study treatment.
    11. Immunocompromised patients.
    12. Patients with known active hepatic disease (i.e. , Hepatitis B or C).
    13. Prior treatment with a known or putative PARP inhibitor.

    Additional Exclusion Criteria for Food Effect Sub-Study:
    With the exception of exclusion criteria 1 and 13 (above), all main study exclusion criteria apply. In addition, the following exclusion criteria apply to the food effect substudy only:
    1. Chemotherapy within 3 weeks of study start.
    2. Patient taking a proton pump inhibitor, antacids, or H2 blocker within 48 hours of dose.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of first documentation of objective progression or death by any cause in the absence of
    documented objective progression whichever occurs first.
    E.5.2Secondary end point(s)
    1. Concordance of the candidate companion diagnostic test compared to centralized BRCA mutation test, if needed
    2. Observed changes from baseline in the following PROs:
    a. FOSI
    b. EQ-5D-5L
    c. Neuropathy questionnaire
    3. Outcomes for the next anticancer therapy following study treatment (best response, dose limiting toxicities, date of progression) will be collected using source documentation.
    4. PFS2 is defined as the time from treatment randomization to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death by any cause. Determination of progression will be by site physician clinical and radiographic assessment (clinic and radiology notes may serve as source documentation).
    5. Chemotherapy-free interval (CFI), the time from last platinum dose until initiation of next anticancer therapy (excluding maintenance therapy). CFI relative to CFI from prior chemotherapy regimens will be evaluated (clinic notes may serve as ource documentation).
    6. Overall survival as measured from the date of randomization to the date of death by any cause.
    7. Time to CA125 progression from time of randomization.
    8. Evaluation of the effects of food on the PK of niraparib.
    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
    (1) To bridge the centralized BRCA mutation test method to a candidate companion diagnostic test, if needed.
    (2) To evaluate additional measures of clinical benefit, including PROs, PFS2, chemotherapy-free interval (CFI) and OS.
    (3) To evaluate the safety and tolerability of niraparib compared to placebo in the indicated target population.
    (4) To evaluate QTc in a subset of niraparib-treated ovarian cancer patients.
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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
    Austria
    Belgium
    Canada
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Norway
    Poland
    Spain
    Sweden
    United Kingdom
    United States
    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 years2
    E.8.9.1In the Member State concerned months10
    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 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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 252
    F.4.2.2In the whole clinical trial 360
    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)
    Follow up according to protocol (see section 3 and 7)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ENGOT Consortium
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
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