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    Summary
    EudraCT Number:2019-001025-28
    Sponsor's Protocol Code Number:NuTide:121
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-001025-28
    A.3Full title of the trial
    A Phase III Open-Label, Multi-Centre, Randomised Study Comparing NUC-1031 plus Cisplatin to Gemcitabine plus Cisplatin in Patients with Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of NUC-1031 plus Cisplatin versus Gemcitabine plus Cisplatin in Previously Untreated Biliary Tract Cancer
    A.4.1Sponsor's protocol code numberNuTide:121
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04163900
    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 SponsorNuCana plc
    B.1.3.4CountryUnited Kingdom
    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 supportNuCana plc
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNuCana plc
    B.5.2Functional name of contact pointNuCana Clinical Study Information
    B.5.3 Address:
    B.5.3.1Street Address3 Lochside Way
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH12 9DT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441313571111
    B.5.6E-mailinfo@nucana.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 nameAcelarin
    D.3.2Product code NUC-1031
    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 INNFosgemcitabine palabenamide
    D.3.9.1CAS number 1562406-27-2
    D.3.9.2Current sponsor codeNUC-1031
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 RoleComparator
    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.2.1.2Country 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 nameGemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGemcitabine
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country 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 nameCisplatin
    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 INNCisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Histologically- or cytologically-confirmed adenocarcinoma of the biliary tract (including gallbladder, intra and extra-hepatic biliary ducts and ampullary [pancreaticobiliary subtype only; see exclusion criterion 1] cancers) that is locally advanced, unresectable or metastatic.
    E.1.1.1Medical condition in easily understood language
    Cancer of the biliary tract
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare NUC-1031/cisplatin (Arm A) to the gemcitabine/cisplatin standard of care (Arm B) and to detect a clinically meaningful improvement in Overall Survival and Objective Response Rate.
    E.2.2Secondary objectives of the trial
    To compare the following between the two treatment arms:
    - Progression-free survival (PFS) based on BICR
    - Duration of response (DoR) based on BICR
    - 18- and 12-month survival
    - Disease control rate (DCR) based on BICR
    To assess the safety and tolerability of NUC-1031
    To explore the pharmacokinetics of NUC-1031
    To assess changes in patient-reported quality of life
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A sub-study will be carried out to assess any potential effects of the NUC-1031 + cisplatin combination on cardiac depolarisation.
    E.3Principal inclusion criteria
    1. Written informed consent and authorisation to use and disclose health information.

    2. Ability to comprehend and willingness to comply with the requirements of this protocol, including the QoL questionnaires.

    3. Female or male patients aged ≥18 years.

    4. Histologically- or cytologically-confirmed adenocarcinoma of the biliary tract (including gallbladder, intra and extra-hepatic biliary ducts and ampullary [pancreaticobiliary subtype only; see exclusion criterion 1] cancers) that is locally advanced, unresectable or metastatic. Patients with measurable (as per RECIST v1.1 criteria) or non-measurable disease are permitted.

    5. Life expectancy ≥16 weeks.

    6. ECOG performance status 0 or 1.

    7. Adequate biliary drainage with no evidence of ongoing infection. If applicable, treatable and clinically-relevant biliary duct obstruction has been relieved by internal endoscopic drainage/stenting at least 2 weeks previously or by palliative bypass surgery or percutaneous drainage prior to study treatment, and the patient has no active or suspected uncontrolled infection. Patients fitted with a biliary stent should be clinically stable and free of signs of infection for ≥2 weeks prior to study treatment. Patients with improving biliary function who meet all other inclusion criteria may be re-tested during the screening window.

    8. Adequate bone marrow, hepatic, and renal function, as evidenced by:
    • Absolute neutrophil count (ANC) ≥1,500/μL without colony-stimulating factor support.
    • Platelet count ≥100,000/μL.
    • Haemoglobin ≥10 g/dL without need for haematopoietic growth factor or transfusion support in prior 2 weeks.
    • Total bilirubin <2 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome. Consistent with inclusion criterion 7, patients whose whole bilirubin and biliary function is recovering may be re-tested during the screening period.
    • ALT and/or AST <5 × ULN
    • Creatinine clearance ≥45 mL/min actual or calculated by the Cockcroft-Gault method.
    • International normalised ratio (INR) <1.5 and partial thromboplastin time (PTT) <1.5 × ULN; does not apply to patients on an anti-coagulant with stable dose 28 days prior to first dose.

    9. QTc interval <450 msec (males) or <470 msec (females), in the absence of bundle branch block. In the presence of bundle branch block with consequent QTc prolongation, patients may be enrolled based on a careful risk-benefit assessment. Patients with the presence of bundle branch block for whom a QT calculation cannot be reliably determined should not be included.

    10. Human Immunodeficiency Virus (HIV)-infected patients who are healthy and have a low risk of Acquired Immune Deficiency Syndrome-(AIDS) related outcomes may be included in this study.

    11. Female patients of child-bearing potential (i.e., all women except those who are post-menopausal for ≥1 year or who have a history of hysterectomy or surgical sterilisation) must have a negative pregnancy test within 3 days prior to the first study drug administration. All patients of child-bearing potential must agree to practice true abstinence or to use two highly effective forms of contraception, one of which must be a barrier method and one of which must be a highly effective form of contraception, from the time of screening until 6 months after the last dose of study medication.

    12. Male patients with a female partner must either have had a successful vasectomy or they and their female partner meet the criteria above (not of childbearing potential or practicing highly effective contraceptive methods).
    E.4Principal exclusion criteria
    1. Combined or mixed hepatocellular/cholangiocarcinoma or ampullary cancer of the intestinal
    or mixed subtypes.

    2. Prior systemic therapy for advanced or metastatic biliary tract cancer. However, prior
    chemotherapy in the adjuvant setting or low-dose chemotherapy given in conjunction with
    radiotherapy in the adjuvant setting and completed at least 6 months prior to enrolment is
    permitted. The following prior interventions are allowed provided the patient has fully
    recovered:
    • Surgery: non-curative resection with macroscopic residual disease or palliative bypass surgery.
    Patients who have previously undergone curative surgery must now have evidence of
    non-resectable disease requiring systemic chemotherapy.
    • Radiotherapy: prior radiotherapy (with or without radio-sensitising low-dose chemotherapy)
    for localised disease and there is now clear evidence of disease progression requiring systemic
    chemotherapy.
    • Photodynamic therapy: prior photodynamic therapy for localised disease with no evidence of
    metastatic disease or for localised disease to relieve biliary obstruction in the presence of
    metastatic disease provided there is now clear evidence of disease progression requiring
    systemic chemotherapy.
    • Palliative radiotherapy: palliative radiotherapy provided that all AEs have resolved and the
    patient has measurable disease outside the field of radiation.

    3. Prior treatment with or known hypersensitivity to NUC-1031, gemcitabine, cisplatin or other
    platinum-based agents or history of allergic reactions attributed to the excipients contained in
    NUC-1031 or diluent solution (dimethylacetamide [DMA], Kolliphor ELP, Tween 80).

    4. Symptomatic central nervous system or leptomeningeal metastases.

    5. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively
    treated in situ cancer of the cervix, low grade prostate cancer not requiring treatment or other
    solid tumours curatively treated with no evidence of disease for ≥3 years.

    6. Concurrent serious (as deemed by the Investigator) medical conditions, including, but not
    limited to, New York Heart Association class III or IV congestive heart failure, history of
    congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or otherco-morbid conditions that in the opinion of the Investigator would impair study participation
    or cooperation.

    7. Congenital or acquired immunodeficiency (e.g., serious active infection with HIV). As per
    inclusion criterion 10, patients with HIV who are healthy and have a low risk of AIDS-related
    outcomes are eligible.

    8. Other acute or chronic medical, neurological, or psychiatric condition or laboratory
    abnormality that may increase the risk associated with study participation or investigational
    product administration or may interfere with the interpretation of study results and, in the
    judgment of the investigator, would make the patient inappropriate for entry into this study.

    9. Prior exposure to another investigational agent within 28 days prior to randomisation.

    10. Major surgery within 28 days prior to randomisation; patient must have completely recovered
    from any prior surgical or other procedures.

    11. Pregnant or breastfeeding.

    12. Residual toxicities from prior treatments or procedures which have not regressed to Grade ≤1
    severity (CTCAE v5.0), except for alopecia or ≤Grade 2 peripheral neuropathy.

    13. Concomitant use of drugs at doses known to cause clinically relevant prolongation of QT/QTc
    interval (see Appendix 3).

    14. Administration of a live vaccination within 28 days prior to randomisation.

    15. Ongoing or recent (≤6 months) hepatorenal syndrome.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS), defined as median time, in months, from the date of randomization to the date of death from any cause.

    Objective response rate (ORR), defined as the peercentage of patients achieving a confirmed complete or partial response to treatment as assessed by blinded independent review according to RECIST v1.1 criteria in patients with measurable disease at baseline. Patients will receive a confirmatory scan 28-42 days after response is first observed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS: Evaluated on an ongoing basis from randomisation, then every 12 weeks from the date of treatment discontinuation until the date of death from any cause, up to a maximum of 18 months after the last patient starts treatment.

    ORR: Evaluated every 9 weeks from start of treatment or, where treatment is stopped with no evidence of progression, every 12 weeks until disease progression or death from any cause, up to a maximum of 18 months after the last patient starts treatment.


    E.5.2Secondary end point(s)
    Progression-free survival (PFS), based on blinded independent review according to RECIST v1.1 criteria and defined as the time from randomisation to the first observation of objective tumour progression or death from any cause.

    Duration of response (DoR), defined as the time from initial clinical response to the first observation of tumour progression or death from any cause as assessed by blinded independent review.

    12-month survival, defined as the proportion of patients still alive at 12 months from randomisation.

    18-month survival, defined as the proportion of patients still alive at 18 months from randomisation.

    Disease control rate (DCR), based on blinded independent review according to RECIST v1.1, defined as the percentage of patients demonstrating a Best Overall Response of Complete Response, Partial Response or Stable Disease.

    Safety and tolerability, assessed by total incidence of Treatment Emergent Adverse Events (TEAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Pharmacokinetics of NUC-1031, and dFdC and dFdU metabolites characterised by maximum observed plasma concentration (Cmax), area under the plasma concentration-time curve (AUC), elimination half-life (t½), terminal elimination rate constant (λz), clearance and volume of distribution. Blood samples taken within 10 minutes post-end of infusion, 2 hours post-end of infusion (±30 minutes) and 6 hours post-end of infusion (±30 minutes) on Day 1 of Cycle 1.

    A robust sub-study will be carried out to assess the effect of the NUC-1031 + cisplatin combination on cardiac repolarisation in a subset of patients. Intensive ECG monitoring will be implemented at a subset of sites to collect QT/QTc data for
    74 patients (approximately 37 patients in each treatment group) during the first 2 cycles of
    treatment to allow robust analysis of ECG parameters.

    Comparison of patient-reported quality of life (QoL) scores in Arm A and Arm B, assessed using the European Organisation for Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ-C30) using the QLQ-BIL21 module, and the 5-level EuroQol five-dimension scale (EQ-5D-5L).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy (PFS, DoR, 18/12-month survival, DCR): at the end of the study.

    Safety: after 50 patients have been randomised in total, at every 6 months and at the end of the study.

    QT/QTc analysis: after completion of the QT sub-study.

    Pharmacokinetics of NUC-1031: end of the study.

    Patient-Reported Quality of Life - at the end of the study.
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Assessment of archival tumour sample characteristics that may further an understanding of the mechanism(s) through which the clinical activity of NUC-1031 is achieved.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Russian Federation
    Spain
    Taiwan
    Turkey
    Ukraine
    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
    The end of study date is defined as the time when 637 deaths have occurred, unless the results for OS meet the pre-specified criterion at an interim analysis to stop for early demonstration of efficacy, or unless the study is terminated early on safety grounds on the recommendation of the IDMC.

    Patients who are still receiving benefit from study treatment at the end of study date may continue study treatment at the discretion of the treating physician until disease progression.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 704
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 124
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 392
    F.4.2.2In the whole clinical trial 828
    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)
    Following participation in the NuTide:121 study patients will be referred back to their oncologist and GP, according to local practice.

    Patients who are still receiving benefit from study treatment at the end of study date may continue study treatment at the discretion of the treating physician in accordance with local regulations until disease progression.
    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 NIHR Clinical Research Network Portfolio
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-12
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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