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    Summary
    EudraCT Number:2015-005019-34
    Sponsor's Protocol Code Number:CTMT212X2106
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-06-01
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-005019-34
    A.3Full title of the trial
    A phase I/II study of safety and efficacy of ribociclib (LEE011) in combination with trametinib (TMT212) in patients with metastatic or advanced solid tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical research study to find out if the combination of two study drugs called ribociclib and trametinib is safe and has beneficial effects in people who have solid tumors
    A.4.1Sponsor's protocol code numberCTMT212X2106
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02703571
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.6E-mailclinicaltrial.enquiries@novartis.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 Yes
    D.2.1.1.1Trade name Mekinist
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.4Pharmaceutical 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 INNTrametinib
    D.3.9.1CAS number 1187431-43-1
    D.3.9.2Current sponsor codeTMT212
    D.3.9.3Other descriptive nameTRAMETINIB DIMETHYL SULFOXIDE
    D.3.9.4EV Substance CodeSUB167251
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 Mekinist
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.4Pharmaceutical 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 INNTrametinib
    D.3.9.1CAS number 1187431-43-1
    D.3.9.3Other descriptive nameTRAMETINIB DIMETHYL SULFOXIDE
    D.3.9.4EV Substance CodeSUB167251
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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.3.2Product code LEE011
    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 INNRibociclib
    D.3.9.2Current sponsor codeLEE011
    D.3.9.4EV Substance CodeSUB31644
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.2.1.1.1Trade name Kisqali
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    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.3.2Product code LEE011
    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 INNRibociclib
    D.3.9.2Current sponsor codeLEE011
    D.3.9.4EV Substance CodeSUB31644
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Solid tumors, Pancreatic Cancer, Colorectal Cancer
    E.1.1.1Medical condition in easily understood language
    Solid tumors, Pancreatic Cancer, Colorectal 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 LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    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 10061451
    E.1.2Term Colorectal 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 LLT
    E.1.2Classification code 10033604
    E.1.2Term Pancreatic 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
    Phase Ib:
    To define the maximum tolerated dose (MTD) and/or the RP2R of
    ribociclib and trametinib in patients with solid tumors


    Phase II:
    To assess overall response rate (ORR) with the combination of ribociclib and trametinib in patients with:
    ● Advanced or metastatic pancreatic adenocarcinoma who have failed at least one prior systemic treatment (Arm 1)
    ● Advanced or metastatic KRAS-mutant CRC who have failed at least two prior lines of treatment (Arm 2)
    E.2.2Secondary objectives of the trial
    Phase Ib and II:
    ● To evaluate the safety and tolerability of ribociclib in combination with trametinib
    ● To characterize the pharmacokinetics (PK) of ribociclib (and metabolite LEQ803) and trametinib when administered in combination

    Phase Ib:
    ● To assess the preliminary anti-tumor activity of ribociclib in combination with trametinib

    Phase II:
    ● To evaluate duration of response (DOR), disease control rate (DCR), time to response (TTR), overall survival (OS), progression-free survival (PFS) and clinical benefit rate (CBR) of ribociclib in combination with trametinib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria (All):
    •Written informed consent must be obtained prior to any study specific
    screening procedures
    •Patient has histologically and/or cytologically confirmed malignancies:
    Phase I:
    • Patients with advanced or metastatic solid tumors who have failed at
    least one prior line of systemic antineoplastic therapy in the advanced
    setting without a standard of care treatment option available;
    Phase II:
    •Advanced or metastatic pancreatic adenocarcinoma who have failed at
    least one prior systemic antineoplastic therapies in the advanced setting
    •Advanced or metastatic KRAS-mutant CRC who have failed at least two
    prior systemic antineoplastic therapies in the advanced setting without a
    standard of care treatment option available. Testing for KRAS mutation
    in patients with CRC using locally approved diagnostic kit will be used for
    eligibility.
    •Phase II only: patient must have measurable disease
    •Patient has an ECOG performance status 0 or 1.
    •Patient has adequate bone marrow and organ function
    •Patient must have specified laboratory values within normal limits or
    corrected to within normal limits with supplements before the first dose
    of study medication on Cycle 1 Day 1:
    •Standard 12-lead ECG values defined
    Other protocol-defined inclusion/exclusion criteria may apply
    E.4Principal exclusion criteria
    Phase II only:
    • Patient has received prior treatment with a MEK inhibitor or a CDK4/6
    inhibitor.
    Phase I and Phase II:
    •Patient with a known hypersensitivity to the study drugs or any of the
    excipients of ribociclib or trametinib.
    •Patient is concurrently using other anti-cancer therapy.
    •Patient has received radiotherapy ≤ 4 weeks or limited field radiation
    for palliation ≤ 2 weeks prior to Cycle 1 Day 1
    •Patient has received local therapy to liver ≤ 3 months of C1D1
    •History of liver disease as follow:
    •Cirrhosis
    •Autoimmune hepatitis
    •Portal hypertension
    •Drug induced liver steatosis
    •Prior systemic anti-cancer treatment within 28 days prior to Cycle 1
    Day 1
    •Prior therapy with anthracyclines at cumulative doses of 450 mg/ m2
    or more for doxorubicin or 900 mg/m2 or more for epirubicin.
    •Patient is currently receiving warfarin or other coumadin derived anticoagulant
    •Patient has a history of deep venin thrombosis or pulmonary embolism
    within 6 months of screening.
    •Patient has a concurrent malignancy or malignancy within 3 years prior
    to Cycle 1 Day 1, with the exception of adequately treated basal or
    squamous cell carcinoma or curatively resected cervical cancer.
    •Patients with central nervous system (CNS) involvement
    •Patient has impairment of GI function or GI disease that may
    significantly alter the absorption of the study drugs
    •History of interstitial lung disease or pneumonitis.
    •Clinically significant, uncontrolled heart disease and/or cardiac
    repolarization abnormality
    •Patient is currently receiving any strong inducers or inhibitors of
    CYP3A4/5 and/or Substances that have a narrow therapeutic window
    and are predominantly metabolized through CYP3A4/5 and cannot be
    discontinued 7 days prior to Cycle 1 Day 1:
    •Patient is currently receiving or has received systemic corticosteroids ≤
    2 weeks prior to starting study drug, or who have not fully recovered
    from side effects of such treatment.
    •History of retinal vein occlusion (RVO)
    Other protocol-defined inclusion/exclusion criteria may apply
    E.5 End points
    E.5.1Primary end point(s)
    Phase Ib
    ● Frequency of dose limiting toxicities (DLTs) at each dose level associated with administration of ribociclib and trametinib in a 28 day cycle

    Phase II
    ● Overall response rate (ORR) defined as the proportion of patients with a best overall confirmed response of complete response (CR) or partial response (PR) as assessed per response evaluation criteria in solid tumors (RECIST) 1.1 by investigator assessment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase Ib
    Safety will be monitored by the assessments described below as well as collecting of the adverse events at every visit (see Table 7-1 of the protocol).

    Phase II
    Imaging assessments will be performed at screening within 28 days prior to Cycle 1 Day 1 and subsequently every 6 weeks during the first 12 months and every 12 weeks thereafter.
    E.5.2Secondary end point(s)
    Phase Ib and II
    ● Adverse Events (AEs), serious AEs (SAEs), changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity.
    ● PK parameters such as but not limited to Cmax, Tmax, and AUC and Cmin for ribociclib (and metabolite LEQ803) and trametinib

    Phase Ib
    ● Progression disease rate defined as the proportion of patients with a progression disease as assessed per RECIST 1.1 by investigator assessment
    ● PFS, defined as time from first dose of study drug to progression or death due to any cause

    Phase II
    ● Duration of response (DOR), calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to any cause
    ● Disease control rate (DCR), time to response (TTR) calculated as the time from first dose to first documented response (CR+PR)
    ● Progression free survival (PFS)
    ● Overall survival (OS), defined as time from first dose of study drug to death due to any cause
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase Ib and II
    Safety will be monitored by the assessments described below as well as collecting of the adverse events at every visit (see Table 7-1 of the protocol).

    Phase Ib
    Imaging assessments will be performed at screening within 28 days prior to Cycle 1 Day 1 and subsequently every 8 weeks during the first 12 months and every 12 weeks thereafter.

    Phase II
    Imaging assessments will be performed at screening within 28 days prior to Cycle 1 Day 1 and subsequently every 6 weeks during the first 12 months and every 12 weeks thereafter.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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 Ib/II
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Phase Ib open label, dose escalation part followed by open-label two-arm non-randomized Phase II
    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 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 concerned2
    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
    Australia
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hong Kong
    Israel
    Italy
    Korea, Republic of
    Netherlands
    Russian Federation
    Singapore
    Spain
    Taiwan
    Turkey
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 91
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 153
    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)
    N/A
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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