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    Summary
    EudraCT Number:2014-004269-26
    Sponsor's Protocol Code Number:ENGOT-ov24-NSGO
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-13
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-004269-26
    A.3Full title of the trial
    Niraparib versus niraparib-bevacizumab combination in Women with platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer.

    Part 1: AVANOVA1 - A phase I study to evaluate the safety and tolerability of bevacizumab-niraparib combination therapy and determine the Recommended Phase 2 Dose (RP2D) in Women with platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer.

    Part 2: AVANOVA2 - A two-arm, open-label, phase II randomized study to evaluate the efficacy of niraparib versus niraparib-bevacizumab combination in Women with platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Niraparib alone or Niraparib and bevacizumab combination in Women with ovarian cancer.
    A.3.2Name or abbreviated title of the trial where available
    AVANOVA
    A.4.1Sponsor's protocol code numberENGOT-ov24-NSGO
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01847274
    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 SponsorNordic Society of Gynaecological Oncology - Clinical Trial Unit
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTESARO
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNordic Society of Gynaecological Oncology - Clinical Trial Unit
    B.5.2Functional name of contact pointNSGO-CTU
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535453311
    B.5.5Fax number4535452898
    B.5.6E-mailnicole.buchner.vinum@regionh.dk
    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.3.2Product code MK-4827
    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 1038915-64-8
    D.3.9.2Current sponsor codeL-001946812-005R, L-001946812
    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.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 Yes
    D.2.1.1.1Trade name AVASTIN 25 mg/ml Concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAVASTIN
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.3Other descriptive nameAVASTIN
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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
    Women with relapsed platinum-sensitive epithelial ovarian cancer
    E.1.1.1Medical condition in easily understood language
    women with relapsed ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061328
    E.1.2Term Ovarian epithelial 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10061344
    E.1.2Term Peritoneal neoplasm
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube 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
    Primary objective:
    Phase 1:
    Safety and tolerability of bevacizumab-Niraparib combination
    Phase 2:
    Compare Progression-Free Survival (PFS)
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    • Part 1 ( Phase 1):
    o determine the Recommended Phase 2 Dose (RP2D) of bevacizumab-Niraparib combination
    o determine the pharmacokinetics (PK) and pharmacodynamics (PDn) of bevacizumab-Niraparib combination
    o describe anti-tumor response in these patients

    Part 2 ( Phase 2 ):
    o To provide preliminary evidence of efficacy enabling the choice of a treatment for a future phase III trial
    o PFS in each group according to trial stratification factors
    o Objective response rate according to RECIST (ORR)
    o Overall response according to GCIG criteria (CA125 response; best overall response in patients without initial measurable disease and who are evaluable by CA125; best overall response with measurable disease and who are also evaluable by CA125)
    o Disease control rate (DCR) (CR+PR+SD)
    o Patient Reported Outcomes (PROs)
    o Safety and tolerability
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    In a subset of 30 patients randomized to combination arm PK and PDn will be determined as follows:

    Blood samples for measurements of plasma levels of niraparib will be obtained on Cycle 1 Day 1 and on Cycle 2/ Day 1 at the following timepoints :
    Predose (within 30 minutes prior to bevacizumab administration) and post dose (within 30 mintes)

    Additional blood samples for measurements of plasma levels of niraparib will be obtained at the time of progression of disease.
    Model predicted AUCs will be derived. Parameters of interest are AUC, Cmin, Cmax, CL/F and Vz/F, AUCss, Cminss, Cmaxss, AUC0-t, and AUC0-inf, Tmax and t1/2.
    E.3Principal inclusion criteria
    1. Recurrent platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer (platinum sensitivity defined as no recurrence within 6 months of last receipt of platinum/chemotherapy).
    2. High-grade serious or high-grade endometrioid histology.
    3. Patient consents to perform HRD test.
    - Patients with known BRCA status: BRCA positive patients must submit the tissue for HRD test, though these patients need not to wait for HRD test results and can be randomized in HRD positive stratum.
    - If tumor tissue is not sufficient to perform HRD test: these patients shall be randomized in HRD negative stratum as HRD unkown.
    4. Prior line of therapy: Patients must have received platinum-containing therapy for primary disease.
    - No limits on number of platinum-based therapies. Population of patients who has previously received ≥ 3 lines of therapy for relapsed disease will be capped at 40%.
    - Up to one non-platinum-based line of therapy in recurrent setting.
    - Patients who are treated with bevacizumab just prior to entering in the trial must not have progressed under or within 3 months after bevacizumab.
    - Patients may have participated in a PARP inhibitor trial as first-line maintenance therapy and have not progressed within 3 months after PARP/placebo. Patients who received PARP inhibitor after relapse (definitive or maintenance therapy) are not eligible.
    5. Target group: Age 18+
    6. Histological confirmed ovarian, fallopian tube or peritoneal cancers
    7. Patients must give informed consent
    8. Patients may have undergone primary or interval debulking surgery
    9. Patients may have received bevacizumab though no other prior use of anti-angiogenic therapy
    10. Patients may have received a PARP inhibitor as first-line maintenance therapy.
    11. Patients must have disease that is measurable according to RECIST or assessable according to the GCIG criteria
    12. The patient agrees to complete PROs (QoL questionnaire) during study treatment AND at one additional time point 8 weeks following progression of disease
    13. ECOG performance status 0-2
    14. Adequate organ function
    o Absolute neutrophil count (ANC) ≥1,5 x 109/L
    o Platelets >100 x 109/L
    o Hemoglobin ≥ 9g/dl
    o Serum creatinine ≤1.5x upper limit of normal (ULN) or 
calculated creatinine clearance ≥50mL/min using Cockcroft-Gault formula
    o Total bilirubin ≤1.5x ULN
    o Aspartate aminotransferase (AST) and alanine 
aminotransferase (ALT) ≤2.5x ULN unless liver metastases are present, in which case they must be ≤5x ULN.
    15. Able to take oral medications
    16. Life expectancy of at least 12 weeks
    17. Patients must fulfill all inclusions criteria and according to investigator fit to receive niraparib and/or bevacizumab.
    18. Women of childbearing potential must use adequate birth control for the duration of study participation
    E.4Principal exclusion criteria
    1. Ovarian sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial cancers and cancer types not mentioned in the inclusion criteria
    2. Concurrent cancer therapy
    3. Concurrent treatment with an investigational agent or participation in another clinical trial
    4. Major injuries or surgery within the past 21 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
    5. Previous malignant disease: patients are not eligible for the study if diagnosis, detection or treatment of invasive cancer (other than ovarian cancer; with the exception of basal or squamous cell carcinoma of the skin that was definitively treated) was detected within 2 years prior to randomization
    6. Active infections or other serious underlying significant medical illness, abnormal laboratory finding or psychiatric illness/social situation that would, in the Investigator’s judgment, makes the patient inappropriate for this study
    7. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
    8. History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction
    9. Known contraindications to PARP inhibitors or VEGF directed therapy
    10. Known uncontrolled hypersensitivity to the investigational drugs
    11. History of major thromboembolic event defined as:
    • Uncontrolled pulmonary embolism (PE)
    • Deep venous thrombosis (DVT)
    • Other related conditions, though patients with stable therapeutic anticoagulation for more than three months prior randomization are eligible for this study. This also apply to PE & DVT.
    12. History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 3 months
    13. History of clinically significant hemorrhage in the past 3 months
    14. Uncontrolled and/or symptomatic CNS metastasis or leptomeningeal carcinomatosis
    (Dexamethasone/prednisone therapy will be allowed if administered as stable dose for at least one month prior randomization)
    15. Significant cardiovascular diseases, including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months prior to randomization, congestive heart failure > NYHA III, severe peripheral vascular disease, QT prolongation >470 msec ,clinically significant pericardial effusion
    16. Pregnancy or breastfeeding. Patients with preserved reproductive capacity, unwilling to use a medically acceptable method of contraception for the duration of the trial and for 3 months afterwards.
    17. Radiographic evidence of cavitation or necrotic tumors with invasion of adjacent major blood vessels
    18. Active or chronic hepatitis C and/or B infection
    19. Persistence of clinically relevant therapy related toxicity from previous chemotherapy
    20. Proteinuria as demonstrated by: (a) urine protein: creatinine (UPC) ratio >/= 1.0 at screening OR (b) urine dipstick for proteinuria >/=2+ (patients discovered to have >/=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hr urine collection and must demonstrate </=1g of protein in24 hours to be eligible
    21. Patients must not have any known history of MDS
    22. Patients must not have known persistent (> 4 weeks) ≥ Grade 2 hematological toxicity from prior cancer therapy
    23. Patients must not have known ≥ Grade 3 thrombocytopenia or anemia with the last chemotherapy regimen.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end-point
    Phase 1: Safety and tolerability of bevacizumab-niraparib combination

    Phase 2: Progression-Free Survival (PFS) of patients treated with:
    Niraparib-bevacizumab combination against niraparib alone
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression-Free Survival (PFS) PFS is defined as the duration of time from date of randomization to date of progression or death, whichever occurs first
    E.5.2Secondary end point(s)
    Phase 1:
    • The Recommended Phase 2 Dose (RP2D) of bevacizumab-niraparib combination
    • The pharmacokinetics (PK) and pharmacodynamics (PDn) of bevacizumab-niraparib combination
    • Anti-tumor response in these patients


    Phase 2 :
    • Objective Response Rate (ORR)
    • Overall response according to GCIG criteria (CA125 response; best overall response in patients without initial measurable disease and who are evaluable by CA125; best overall response with measurable disease and who are also evaluable by CA125)
    • Disease control rate (DCR) (CR+PR+SD)
    • Patient Reported Outcomes (PROs)
    • Safety and tolerability
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints for phase 1 will be during the study. Evaluation after 3 patients in 1 cycle each cohort.

    For phase 2 , the endpoints will not be evaluable until after the study ends and all data have been collected.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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
    phase 1a, open-label, dose-escalation study to evaluate the safety and tolerability
    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 Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Denmark
    Finland
    Norway
    Sweden
    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
    The end of study will occur as the date of the last visit of the last patient undergoing the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-02-13. Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 110
    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)
    None
    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 European Network of Gynaecological Oncological Trial Groups
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Gynecologic Cancer Intergroup
    G.4.3.4Network Country Canada
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-01
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