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    Summary
    EudraCT Number:2012-005111-12
    Sponsor's Protocol Code Number:CR13
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-04-08
    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 number2012-005111-12
    A.3Full title of the trial
    FOCUS4 – Molecular selection of therapy in colorectal cancer: a molecularly stratified randomised controlled trial programme
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FOCUS4: Molecular selection of therapy in colorectal cancer
    A.3.2Name or abbreviated title of the trial where available
    FOCUS4: Molecular selection of therapy in colorectal cancer
    A.4.1Sponsor's protocol code numberCR13
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN90061546
    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 SponsorUniversity College London
    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 supportNIHR/MRC Efficacy and Mechanism Evaluation (EME) programme
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportCancer Research UK (CRUK)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College London
    B.5.2Functional name of contact pointMarta Campos
    B.5.3 Address:
    B.5.3.1Street Address2nd Floor, ICTM, MRC CTU at UCL, 90 High Holborn
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1V 6LJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02031089906
    B.5.5Fax number02076704818
    B.5.6E-mailmrcctu.focus4@ucl.ac.uk
    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 nameAZD8931 film-coated tablet 20 mg
    D.3.2Product code AZD8931
    D.3.4Pharmaceutical form Film-coated 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 INNAZD8931 Difumarate (INN: sapitinib)
    D.3.9.1CAS number 1196531-39-1
    D.3.9.2Current sponsor codeAZD8931difumarate
    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 number20
    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 Information not present in EudraCT
    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 nameCapecitabine
    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 INNCapecitabine
    D.3.9.1CAS number 154361-50-9
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number500
    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 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 Aspirin
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAspirin
    D.3.4Pharmaceutical form Film-coated 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 INNAspirin
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeAS4
    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: 4
    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 nameAZD1775
    D.3.2Product code AZD1775
    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 INNAZD1775 hemihydrate
    D.3.9.1CAS number 1277170-60-1
    D.3.9.2Current sponsor codeAZD1775
    D.3.9.3Other descriptive nameMK-1775 hemihydrate; L001739996-008U, AZ13737568 hemihydrate
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 100
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    metastatic or locally advanced colorectal cancer
    E.1.1.1Medical condition in easily understood language
    Cancer of the bowel that is not completely removable by surgery or it has spread to elsewhere in the body
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.2System Organ Class 100000004864
    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 objectives are:

    1) For patients with the same tumour type (characterised by the results of the molecular tests), do the proposed new agents significantly increase the length of time for a patient to die, or for their tumour to increase in size by at least 20% when compared to patients having a treatment break after their first-line chemotherapy, in the time period after standard first-line?

    2) Do the patients who have a particular genetic mutation identified by the molecular tests respond better to a proposed new agent than the patients who do not have that particular mutation?
    E.2.2Secondary objectives of the trial
    Secondary research questions are:

    1) Do the patients taking the proposed new agents experience an unacceptably higher level of toxicity symptoms and side-effects compared to the patients in the no treatment comparison group?

    2) Are there any differences in safety outcomes (eg. occurence of heart or kidney disease) between the patients taking the proposed new agents and those in the no treatment comparison group?

    3) Does quality of life (measured by the EuroQol 5D questionnaire) differ between the patients taking the proposed new agents and those in the no treatment comparison group? This is currently only applicable to patients in FOCUS4-N.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biopsy Sub-study: Fresh tumour biopsies before starting trial treatment and on progression will be requested from those patients with accessible tumour and who give consent to extra biopsies. Recent evidence has revealed how heterogeneous (variable) an individual's cancer is and that each cancer is unique to that individual. In addition, cancers can change as a result of exposure to therapy. This sub study will compare the molecular characteristics before starting trial treatment and on progression to those found in the original diagnostic biopsy. The aim is to identify more accurate biomarkers that predict response to one of the treatments. We also aim to discover the ways that resistance occurs to the treatments to see if we can identify better treatments in the future.
    E.3Principal inclusion criteria
    1.Male or female patients at least 18 years old at registration
    2.FFPE tumour block taken prior to the commencement of standard first-line treatment and available for biomarker analysis
    3.Histologically confirmed adenocarcinoma of the small bowel or colon or rectum
    4.Inoperable metastatic or locoregional disease (synchronous or metachronous)
    5.WHO performance status 0, 1 or 2 (see Appendix III)
    6.Disease which could be RECIST reported v1.1 classification as unidimensionally measurable disease (see Appendix IV) from the CT scan taken following inclusion criteria 7.
    7.Have had an electronically accessible CT scan performed. This scan should ideally be performed just before but no more than six weeks prior to commencement of standard first-line treatment. Unavoidable delays of a few days for scheduling reasons may be approvable, but sites must contact the MRC CTU prior to registering the patient. CT scans performed a few days after the start date of standard first-line treatment may also be approvable, but only due to uncontrollable circumstances and only after discussion with the MRC CTU team and prior to registering the patient.
    8.Women of child bearing potential must be willing to use adequate contraceptive measures (see Appendix V for contraindications of oral contraceptives) from registration into FOCUS4 to 7 weeks after ending first-line treatment and during, and 6 weeks after any subsequent randomised treatment in one of the FOCUS4 comparisons, should not be breastfeeding and must have a negative pregnancy test at any point prior to registration. Women of non-child bearing potential should fulfil one of the following criteria at screening:
    Post menopausal as defined by:
    Aged ≥50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
    Aged <50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments and with luteinising hormone and follicular stimulating hormone levels in the post-menopausal range
    Documentation of irreversible surgical sterilisation by hysterectomy, and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal ligation
    9.Male patients with partners of child bearing potential should be willing to abstain or use barrier contraception (i.e., condoms) for the duration of standard first-line treatment following registration and for 3 months after stopping any treatment administered as part of FOCUS4 (standard first line treatment, or subsequent randomised treatment). Male patients wishing to father children whilst taking standard first-line treatment and 3 months after stopping standard first-line treatment should be counselled on freezing sperm samples before starting standard first-line treatment.
    10.Consent for screening of an archival FFPE tumour block for biomarker analysis
    11.Patients who have already commenced on standard first-line treatment must be registered for the trial during the first 12 weeks of first-line treatment (this allows approximately 6 weeks for return of their biomarker results prior to the end of first-line treatment)
    12.Patients should have sufficient capacity for informed consent assessed at the treating physicians discretion
    13.Patient has provided signed informed consent

    For inclusion criteria for randomisation into FOCUS4-C, please refer to section 3.3.1 of the FOCUS4-C protocol v6.0 dated 17.09.2019.

    For inclusion criteria for randomisation into FOCUS4-N, please refer to section 3.3.1 of the FOCUS4-N protocol v5.0 dated 11.09.2019.
    E.4Principal exclusion criteria
    1.Any previous systemic palliative chemotherapy for established advanced or metastatic disease except single agent capecitabine as a radiosentiser in a setting with potential curative intent such as leading to possible resection.
    2.Adjuvant chemotherapy given in the 6 months prior to commencing standard first-line treatment
    3.Patients with brain metastases
    4.Pregnant and lactating women
    5.Patients with known HIV, hepatitis B or hepatitis C infection


    For exclusion criteria for randomisation into FOCUS4-C, please refer to section 3.3.2 of the FOCUS4-C protocol v6.0 dated 17.09.2019.

    For exclusion criteria for randomisation into FOCUS4-N, please refer to section 3.3.2 of the FOCUS4-N protocol v5.0 dated 11.09.2019.
    E.5 End points
    E.5.1Primary end point(s)
    There are no primary outcome measures for the registration period as no interventions are being compared during this period.

    The primary outcome measure for the subsequent FOCUS4 comparisons that commence at the end of the registration period will be Progression-Free Survival (PFS) defined as progression of disease according to RECIST v1.1 criteria or death from any cause. Analysis will be timed from randomisation with the baseline CT scan performed within 4 weeks prior to randomisation.

    For trials that complete Stage III, at this point, a decision will be made on whether to revise power calculations to include Overall Survival (OS) as an additional primary outcome measure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each molecular cohort utilises the Multi-Arm, Multi-Stage (MAMS) design and incorporates pre-specified interim analyses. The nstage programme in STATA statistical software uses previous data on event rates for the primary outcome to anticipate when the interim analyses are likely to occur.
    For FOCUS4-C (see specific trial protocol for details)
    Stage I - 17 months
    Stage II - 28 months
    FOCUS4-N does not utilise a MAMS approach but interim analyses will still be performed with stopping rules based upon either harm or benefit in the capecitabine arm. An IDMC Charter will describe the decision-making processes including stopping rules and the timing of interim analyses.
    E.5.2Secondary end point(s)
    Secondary outcomes will include evaluation of disease control, safety and toxicity starting from time of randomisation. In some instances measurement of quality of life using the EuroQol 5D questionnaire may be used for trials that proceed beyond Stage II.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Analysis of the secondary endpoints is likely to coincide with the analyses for the primary outcomes but this will be at the discretion of the IDMC.
    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 Yes
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    Active Monitoring
    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 concerned94
    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 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 FOCUS4 Trial Programme will be considered closed 12 months after the last patient’, last visit
    has been completed for the last comparison. Further long-term follow-up may be completed via
    linkage with central NHS data registries for the patients who have consented for their data to be
    used.
    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 months1
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months1
    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: 2270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1930
    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 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 state4200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4200
    F.4.2.2In the whole clinical trial 4200
    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)
    Trial treatments will be made available for patients until disease progression. If a patient is free of progression at the time the trial they are participating has closed, negotiations will occur so arrangements are in place with the drug supplier for continuation of trial treatment for the few expected patients in this situation. On progression of disease further treatment decisions lie with the patient and their doctor.
    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 - Cancer (CRN)
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-10
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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