Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38870   clinical trials with a EudraCT protocol, of which   6391   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-004780-13
    Sponsor's Protocol Code Number:CeNturIOn-2016
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-06-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-004780-13
    A.3Full title of the trial
    An open-label, randomised, phase II trial of ruCaparib combined with Nivolumab +/- Ipilimumab to augment response in homologous repair deficient patients with relapsed Ovarian, primary peritoneal and fallopian tube cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to investigate whether the addition of nivolumab or nivolumab and ipilimuab to rucaparib improves effectiveness, compared with rucaparib alone, in patients with relapsed ovarian cancer.
    A.3.2Name or abbreviated title of the trial where available
    CeNturIOn
    A.4.1Sponsor's protocol code numberCeNturIOn-2016
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN10490346
    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 SponsorNHS Greater Glasgow & Clyde
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Glasgow
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namerucaparib
    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 INNRucaparib
    D.3.9.1CAS number 283173-50-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRucaparib
    D.3.9.1CAS number 283173-50-2
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRucaparib
    D.3.9.1CAS number 283173-50-2
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 nivolumab
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 namenivolumab
    D.3.4Pharmaceutical form Concentrate for 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 INNnivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.4EV Substance CodeAS4
    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 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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 Yes
    D.2.1.1.1Trade name ipilimumab
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 nameipilimumab
    D.3.4Pharmaceutical form Concentrate for 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 INNipilimumab
    D.3.9.1CAS number 477202-00-9
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    High grade serous ovarian cancer (includes histologically identical fallopian tube and primary peritoneal cancers and high grade G3 endometrioid histological subtypes)
    E.1.1.1Medical condition in easily understood language
    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 10066697
    E.1.2Term Ovarian cancer recurrent
    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 compare the length of remission from ovarian, primary peritoneal and fallopian tube cancer for patients taking rucaparib alone with patients on combinations of rucaparib with nivolumab or nivolumab and ipilimumab. This will be assessed using scan changes to show cancer shrinkage. Only patients with cancer that has come back and whose cancer is likely to respond to rucaparib (based on testing of their cancer tissue) will be recruited.
    E.2.2Secondary objectives of the trial
    To assess the relative efficacy and safety of the addition of nivolumab +/- ipilimumab to rucaparib compared to rucaparib alone.
    Overall Response (based on RECIST 1.1), RECIST and GCIG CA125 criteria and Ir-RECIST
    Duration of RECIST Response
    Overall Survival
    Safety and Tolerability (toxicities will be coded using NCI-CTCAE Version 5)
    Quality of Life (as measured by EQ-5D questionnaire)
    Resource use for health economic assessment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥16 yrs
    - Written informed consent
    - Histologically confirmed high-grade serous or Grade 3 endometrioid relapsed (as defined by RECIST v1.1) epithelial ovarian, fallopian tube, or primary peritoneal cancer:
    If mixed histology >50% of the primary tumour must be confirmed to be high-grade serous or endometrioid upon review by local pathology with <50% being ‘other’, generally carcinosarcoma
    Patients with high grade ovarian cancer histology of other than serous or endometrioid are also eligible if they are already known to harbour a deleterious germline or somatic BRCA1/2 mutation
    NB patients who have an original diagnosis based on cytology only will not be eligible for trial entry unless a biopsy confirming criteria above is performed
    - Received ≥1 prior platinum containing chemotherapy regimen(s).Patients can have had up to 3 prior lines (including primary therapy) of therapy for ovarian cancer. Agents administered in the maintenance setting will not be counted as a separate regimen but these must have been stopped at least 28 days prior to trial treatment. Hormonal agents (e.g. tamoxifen, letrozole, etc.), anti-angiogenic agents (e.g. bevacizumab, pazopanib, cediranib, etc.) and other non-chemotherapy agents will not be counted as a chemotherapy regimen but must have been stopped at least 28 days prior to trial treatment. No previous PARP inhibitor, anti-PD-1 or anti-PDL-1 or CTLA4 therapy.
    - Had documented treatment-free interval of ≥3 - <12 months following the last chemotherapy regimen received. These time points are defined as time between Day 1 last cycle (this does not have to be a platinum but could be single agent liposomal doxorubicin or weekly taxol) and RECIST evaluable disease progression
    -Has documented platinum free interval of ≥3 - <12 months from last platinum containing regimen. These time points are defined as time between Day 1 last cycle and first subsequent RECIST evaluable disease progression.
    - RECIST evaluable disease (by RECIST criteria v1.1). Patients with CA125 progression in the absence of RECIST measurable disease will NOT be eligible
    - Already known to have a deleterious germline or somatic BRCA1/2 mutation (central confirmation still required)OR be gBRCAwt LoHHIGH as confirmed by the central laboratory (Foundation Medicine)
    NB: Tissue from BRCA mutant patients already identified locally will be required for confirmation. Sufficient archival formalin-fixed paraffin-embedded (FFPE) tumour tissue of adequate quality (see below) must be available for the central laboratory testing. Cytospin blocks from ascites are not acceptable. To be acceptable for Foundation Medicine testing, tumour tissue must be the most recently obtained specimen with at least 30% tumour content, and a minimum of 80% nucleated cellular content. In the event that archival tumour tissue is not available a screening biopsy sample must be collected and provided to the central laboratory
    - Willingness to undergo mandatory biopsy pre cycle1 day1 (where technically feasible)(target lesions (RECIST criteria v1.1) should be avoided if possible).Patient who do not have disease amenable to biopsy are exempt from the biopsy provided all other inclusion criteria are met, they must have archival tumour tissue available for FM testing
    - Adequate haematological and biochemical function as indicated below, performed within 14 days prior to randomization:
    Absolute neutrophil count ≥1.5 x 109/L
    Platelet count ≥100 x 109/L
    Haemoglobin ≥90 g/L
    Serum creatinine <1.5xULN or creatinine clearance ≥45 mL/min (measured or calculated by Cockcroft and Gault equation/Wright formula); confirmation of creatinine clearance is only required when serum creatinine is >1.5xULN
    Total bilirubin <1.5xULN. In cases of Gilbert’s syndrome, bilirubin <2xULN is allowed
    Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <3xULN if no demonstrable liver metastases or <5xULN in the presence of liver metastases
    Alkaline phosphatase <5xULN
    - Willingness to comply with scheduled visits, treatment plans and lab tests and other trial procedures.
    - Evidence of non-childbearing status. For women of childbearing potential: negative serum pregnancy test within 7 days of randomisation and 1 day of trial treatment
    - Patients with synchronous tumours
    -Life expectancy of >12 wks
    -ECOG 0 or 1
    E.4Principal exclusion criteria
    - Prior chemotherapy, biological therapy, radiation therapy, hormonal anti-cancer therapy, immunotherapy, other anticancer agents within 28 days of starting trial treatment (does not include palliative radiotherapy at focal sites which cannot be used as measurable RECIST target sites). Treatment with any other investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer.
    - Any prior PARP inhibitor, anti PD-1 or anti PD-L1, anti-PD-L2, anti-CD137, or cytotoxic T lymphocyte-associated antigen 4 (CTLA4) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
    - Pregnant or lactating
    - Women of childbearing age and reproductive potential who are not willing, or their male partners are not willing, to use two highly effective forms of contraception.
    - With the exception of alopecia and stable peripheral neuropathy from previous taxanes, any unresolved toxicities from prior chemotherapy should be no greater than CTCAE G1 at time of starting trial treatment
    - Major surgery within 3weeks or minor surgery within 5days of trial entry (excluding placement of vascular access devices)
    - Spinal cord compression, known leptomeningeal involvement or brain metastases, unless treated and stable off steroids for at least 4 weeks prior to randomization
    - Warfarin is not permitted.Anticoagulation with low molecular weight heparin and anti Factor X is allowed. Patients who have a new diagnosis of deep vein thrombosis or pulmonary embolism within 2 weeks of randomisation are permitted if clinically stable on a therapeutic dose of LMWH or anti-Factor X.
    - Any haemopoietic growth factors (e.g G-CSF, GM-CSF, erythropoeitin) and blood/platelet transfusions within 2weeks prior to randomization or patients requiring regular blood transfusions (e.g 2 or more times in the 4weeks prior to first dose of trial drug),granulocyte colony-stimulating factor,or platelet transfusions.
    - Hospitalization for bowel obstruction within 3months prior to randomization
    - Any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
    - Has a known diagnosis of immunodeficiency, active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (screening for these is not required). Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7days prior to first dose of trial treatment. Includes prior organ transplantation including allogenic stem-cell transplant. The following are exceptions to this exclusion criterion:
    a.Intranasal, inhaled, topical steroids, or local steroid injections (e.g intra-articular injection)
    b.Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
    c.Steroids as premedication for hypersensitivity reactions (e.g CT scan premedication)
    - Has a known history of active TB (Bacillus Tuberculosis)
    - Previous additional malignancy that is processing or has required active treatment in the last 2years. Exceptions include:
    o Non-melanomatous skin cancer (if adequately treated)
    o previous DCIS or breast cancer > 5 years as long as adequately treated or
    o in situ or early (up to stage 1B1) cervical cancer (if adequately treated)
    o VIN or vulval cancer (if adequately treated)
    o prior or synchronous endometrial cancer (if adequately treated), provided all of the following criteria are met: G1 or G2, no LVSI and FIGO (2010) stage IA only
    - Has active autoimmune disease that has required systemic treatment in the past 2years (i.e with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with diabetes typeI, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
    - Has received a live vaccine within 30 days of planned start trial therapy.
    - Any evidence of severe or uncontrolled systemic disease
    - Hypersensitivity to trial IMPs and their excipients
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) based on RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will have scans performed every 8 weeks during the first year, thereafter 16 weekly until RECIST disease progression.
    E.5.2Secondary end point(s)
    To assess the relative efficacy and safety of the addition of nivolumab +/- ipilimumab to rucaparib compared to rucaparib alone.
    •Overall Response (based on RECIST v1.1, RECIST and GCIG CA125 criteria and Ir-RECIST)
    •Duration of RECIST Response
    •Overall Survival
    •Safety and Tolerability (toxicities will be coded using NCI CTCAE Version 5)
    •QoL as measured by EQ-5D
    •Resource use for health economic assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Scans will be performed every 8 weeks during the first year, thereafter 16 weekly until RECIST disease progression.
    Toxicities will be assessed at every clinic visit, at the end of treatment visit, and for up to 100 days post last dose of trial treatment.
    Questionnaires will be completed at the start of each treatment cycle, at the end of treatment visit, and at each follow-up visit until patient has progressed.
    Resource use will be assessed at each visit, at the end of treatment visit, and at each follow-up visit until patient has progressed.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 Yes
    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) Yes
    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 concerned29
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    For the purpose of complying with UK Clinical Trial Regulations, the trial will be considered ‘closed’ when the follow-up point for the primary analysis of the final experimental arm has been reached. However, the intention is that further observational follow-up of all patients enrolled in the trial may continue until all randomised patients have died. This will initially be via the trial sites, but in longer term may use national registers.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 92
    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 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 state252
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 252
    F.4.2.2In the whole clinical trial 252
    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)
    However, any subsequent anti-cancer treatment should only be given once the patient has met the primary trial end-point of RECIST progression.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-22
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA