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    Summary
    EudraCT Number:2016-002311-18
    Sponsor's Protocol Code Number:CL3-95005-004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-002311-18
    A.3Full title of the trial
    An open-label early access phase IIIb study of trifluridine / tipiracil (S 95005/TAS-102) in patients with a pretreated metastatic colorectal cancer.
    An open-label early access phase IIIb study of trifluridine / tipiracil (S
    95005/TAS-102) in patients with a pretreated metastatic colorectal cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An early access study of trifluridine / tipiracil (S 95005/TAS-102) in patients with a pretreated metastatic colorectal cancer.
    Studio di accesso precoce, di fase IIIb, in aperto di trifluoridina/tipiracil (S95005/TAS-102) in pazienti con carcinoma del colon-retto metastatico precedentemente trattati.
    A.3.2Name or abbreviated title of the trial where available
    An early access study of trifluridine / tipiracil (S 95005/TAS-102) in patients with a pretreated m
    Studio di accesso precoce di fase IIIb in aperto di trifluoridina/tipiracil (S95005/TAS-102) in pazi
    A.4.1Sponsor's protocol code numberCL3-95005-004
    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 SponsorINSTITUT DE RECHERCHES INTERNATIONALES SERVIER
    B.1.3.4CountryFrance
    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 supportADIR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO DI RICERCA SERVIER srl
    B.5.2Functional name of contact pointProject Manager : Alessandra Tambur
    B.5.3 Address:
    B.5.3.1Street AddressVia Luca Passi 85
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00166
    B.5.3.4CountryItaly
    B.5.4Telephone number003906669081
    B.5.5Fax number00390666908738
    B.5.6E-mailinfoirs@servier.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 Lonsurf
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier
    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 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 INNTRIFLUORIDINA
    D.3.9.2Current sponsor codeS95005
    D.3.9.3Other descriptive nameTRIFLURIDINE
    D.3.9.4EV Substance CodeSUB11291MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIPIRACIL HYDROCHLORIDE
    D.3.9.2Current sponsor codeS95005
    D.3.9.4EV Substance CodeSUB174132
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    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 Lonsurf
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier
    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 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 INNTRIFLUORIDINA
    D.3.9.2Current sponsor codeS95005
    D.3.9.3Other descriptive nameTRIFLURIDINE
    D.3.9.4EV Substance CodeSUB11291MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIPIRACIL HYDROCHLORIDE
    D.3.9.2Current sponsor codeS95005
    D.3.9.3Other descriptive nameTIPIRACIL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB174132
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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
    Metastatic colorectal cancer
    Carcinoma colon-rettale metastatico
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer
    Carcinoma colon-rettale
    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 PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    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
    The primary objective of this study is to collect additional safety data during treatment with trifluridine / tipiracil in patients with a pretreated mCRC.
    L¿obiettivo di questo studio ¿ quello di raccogliere dati aggiuntivi relativi alla sicurezza durante il trattamento con trifluoridina/tipiracil in pazienti con carcinoma colon-rettale metastatico pretrattato.
    E.2.2Secondary objectives of the trial
    - Progression free survival (PFS) based on Investigator assessment
    - Quality of life (QoL) using the questionnaires EQ-5D and EORTC QLQ-C30
    - Sopravvivenza senza progressione di malattia (PFS) basata sulla verifica dello sperimentatore
    - Qualit¿ della vita (QoL) usando i questionari EQ-5D e EORTC QLQ-C30
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or Female participant aged =18 years old
    - Has definitive histologically confirmed adenocarcinoma of the colon or rectum
    - Has metastatic lesion(s).
    - Has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies
    - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the screening period
    - Is able to take medications orally (i.e., no feeding tube).
    - Has adequate organ function
    - Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication. Women and female partners using hormonal contraceptive must also
    use a barrier method.
    -Partecipanti maschi o femmine di età = 18 anni
    -Adenocarcinoma del colon o retto definitivo e confermato istologicamente.
    -Presenza di lesioni metastatiche
    -Pazienti che hanno ricevuto almeno 2 regimi precedenti di chemioterapici standard (inclusi fluoropirimidine, oxaliplatino e irinotecan, anticorpi monoclonali anti-VEGF, e almeno uno degli anticorpi monoclonali anti-EGFR per i pazienti RAS wild-type) per il mCRC e che sono refrattari o intolleranti a quei chemioterapici o non sono candidabili all’utilizzo di quei chemioterapici.
    -Performance status dell’Eastern Cooperative Oncology Group (Has Eastern Cooperative Oncology Group -ECOG-) pari a 0 o 1 durante il periodo di screening.
    -Il paziente è in grado di assumere farmaci oralmente (i.e. no tubo di alimentazione)
    -il paziente ha un'adeguata funzione di organo
    -Le donne in età fertile devono essere negative al test di gravidanza sierico nei 7 giorni precedenti il primo
    giorno di somministrazione del farmaco sperimentale
    -Per tutta la durata dello studio e per i 6 mesi successivi l’interruzione del farmaco sperimentale, le partecipanti in età fertile e i partecipanti maschi con partner in età fertile devono accettare di utilizzare metodi anticoncezionali efficaci
    -Donne e partner donne che usano contraccettivi ormonali devono anche usare un metodo barriera
    E.4Principal exclusion criteria
    - Pregnancy, breastfeeding or possibility of becoming pregnant during the study
    - Eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil
    - Has previously received trifluridine / tipiracil or hypersensitivity to the active substances or to any of the excipients of trifluridine / tipiracil
    - Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
    - Has certain serious illness or medical condition(s) described in the protocol
    - Has had certain other recent treatment e.g. major surgery, anticancer therapy, radiation therapy, participation in another interventional study, within the specified time frames prior to first day of study drug administration
    - Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).
    -Gravidanza, allattamento, o possibilità di rimanere incinta durante lo studio
    -Paziente idoneo all’arruolamento in un altro studio clinico di trattamento con trifluoridina/tipiracil in corso.
    - il paziente ha precedentemente ricevuto trifluoridina/tipiracil o ha mostrato ipersensibilità alle sostanze attive o a qualunque eccipiente di trifluoridina/tipiracil
    -Il paziente presenta problemi ereditari di intolleranza al galattosio, carenza della Lapp lattasi, o malassorbimento del glucosio-galattosio.
    -presenta una patologia o condizioni cliniche gravi descritte nel protocollo
    -il paziente ha ricevuto altri trattamenti precedenti come chirurgia maggiore, terapia antitumorale, radioterapia, partecipazione ad altri studi interventistici, entro la predefinita e tempistica antecedente la prima assunzione della terapia in sutdio
    -Tossicità non risolta maggiore o uguale al grado 2 della Common Terminology Criteria for Adverse Events (CTCAE) attribuita ad una qualunque terapia precedente (esclusa anemia, alopecia, pigmentazione della pelle, e neurotossicità indotta dal platino).
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability assessed by: - Incidence of Adverse Events - Laboratory tests: haematology, blood biochemistry, urinalysis - Physical examination and performance status (ECOG) - Vital signs: blood pressure, heart rate, body temperature, body weight
    Sicurezza e tollerabilità valutata da:-incidenza di eventi avversi -test di laboratorio: ematologia, emato- biochimica, urinanalisi –Esame fisico e performance di status (ECOG) -Segni vitali: pressione sanguigna, battito cardiaco, temperatura corporea, peso corporeo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Incidence of Adverse Events: all over the study Laboratory tests, physical examination, performance status, vital signs: at baseline, every 4 weeks during study treatment from cycle 2, at withdrawal visit.
    Incidenza degli eventi avversi: per tutta la durata dello studio. Test di laboratorio , esame fisico, status di performance, segni vitali: alla baseline, ogni 4 settimane durante il trattamento in studio dal ciclo 2, alla visita di withdrawal
    E.5.2Secondary end point(s)
    Progression free survival (PFS) Quality of life (QoL) using the questionanir EQ-5D an EORTC QLQ-C30
    -Sopravvivenza senza progressione di malattia (PFS) ¿Qualit¿ della vita (QoL) usando i questionari di EQ-5D e EORTC QLQ-C30
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor assessment based o general practices and standard of care of the site -Quality of Life: at baseline,every 4 weeks during study tratment form cycle 2,a twithdrawal visit (if not performed qithin the previous 4 weeks).
    Valutazione del tumore basata sulle normali pratiche cliniche e sugli standard di cura del centro ¿ Qualit¿ della vita: al basale, ogni 4 settimane durante il trattamento dello studio dal ciclo 2 alla visita di withdrawal (se non effettuata nella 4 settimane precedenti)
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Quality of life measurements and Medical Resource Utilization (MRU) data
    MIsure della qualita della vita e Medical Resource Utilisation (MRU) dei dati
    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 Yes
    E.7.1.3.1Other trial type description
    Therapeutic confrimatory (phase III)
    Conferma terapeutica (fase III)
    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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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 Information not present in EudraCT
    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
    Brazil
    Turkey
    Belgium
    Bulgaria
    Croatia
    France
    Ireland
    Italy
    Poland
    Portugal
    Romania
    Slovakia
    Slovenia
    Spain
    Switzerland
    Argentina
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 550
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 450
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1000
    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)
    After the discontinuation of the IMP, the participant will access to an appropriate medical care by his doctor; who will provide the best support care.
    Specific rules may be followed in some countries according to local regulation.
    Dopo l'interruzione dell'IMP, il partecipante avr¿ accesso ad un appropriato supporto medico da parte del suo medico il quale fornir¿ le migliori cure possibili
    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 Decision2016-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
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