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    Summary
    EudraCT Number:2015-004544-18
    Sponsor's Protocol Code Number:CL2-95005-002
    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:2021-09-07
    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 number2015-004544-18
    A.3Full title of the trial
    An open-label, randomised, non-comparative phase 2 study evaluating S 95005 (TAS-102) plus bevacizumab and capecitabine plus bevacizumab in patients with previously
    untreated metastatic COlorectal cancer who are non-eligible for intensive therapy
    Studio di fase 2 in aperto, non comparativo, randomizzato, per la valutazione di S 95005 (TAS-102) più bevacizumab e capecitabina più bevacizumab in pazienti con carcinoma del COlon-retto metastatico non precedentemente trattati che non siano candidabili per una terapia intensiva (studio TASCO1)”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 study evaluating S 95005 (plus bevacizumab and capecitabine plus bevacizumab in patients with previously
    untreated metastatic colorectal cancer who are non-eligible for intensive therapy
    Studio di fase 2 i, per la valutazione di S 95005 (più bevacizumab e capecitabina più bevacizumab in pazienti con carcinoma del COlon-retto metastatico non precedentemente trattati che non siano candidabili per una terapia intensiva
    A.3.2Name or abbreviated title of the trial where available
    TASCO1 study
    Studio TASCO1
    A.4.1Sponsor's protocol code numberCL2-95005-002
    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
    B.5.2Functional name of contact pointProject manager: Alessandra Tamburr
    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@netgrs.it
    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.3.1Product nameS95005
    D.3.2Product code [S95005]
    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 INNTRIFLURIDINA
    D.3.9.2Current sponsor codena
    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 number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIPIRACIL HYDROCHLORIDE
    D.3.9.2Current sponsor codeNA
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.3.1Product nameS95005
    D.3.2Product code [S95005]
    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 INNTRIFLURIDINE
    D.3.9.2Current sponsor codena
    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 codeNA
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.1Product namebevacizumab
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.1Product namebevacizumab
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    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.2.1.1.1Trade name Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.1Product nameCapecitabine
    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 INNCapecitabine
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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: 6
    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.2.1.1.1Trade name Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.1Product nameCapecitabine
    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 INNCapecitabine
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Cancro metastatico colorettale
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer
    Cancro colorettale
    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
    To evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.
    Valutare la sopravivvenza libera da progressione (Progression Free Survival, PFS), in pazienti che ricevono S95005 + bevacizumab (braccio sperimentale) o capecitabina + bevacizumab (braccio di controllo) come prima linea di trattamento per cancro metastatico colorettale non resecabile in pazienti non elegibili per terapia intensiva
    E.2.2Secondary objectives of the trial
    ­To evaluate the­ overall response rate (ORR), ­duration of response (DR), disease control rate (DCR), overall survival (OS), safety and tolerability, quality of life (QoL) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.
    Exploratory: Evaluate the biomarkers potentially predictive of response and resistance to S 95005 given in combination using blood samples and archived tumour biopsy (if available).
    Valutare il tasso di risposta globale (Overall Response Rate, ORR)
    -Durata della risposta (Duration of Response, DR)
    Tasso di controllo della malattia (Disease Control Rate, DCR)
    Sopravivvenza globale (Overall Survival, OS)
    Sicurezza e tollerabilità
    Qualità della vita (QoL) in pazienti che ricevono S95005+bevacizumab (braccio sperimentale) o capecitabina+bevacizumab (braccio di controllo) come trattamento di prima linea per cancro metastatico colorettale non resecabile in pazienti non elegibili per terapia intensiva.
    Esploratori: Valutare i biomarcatori potenzialmente predittivi di risposta e di resistenza a S 95005 somministrato in combinazione attraverso campioni di sangue e tessuto tumorale archiviato (se disponibile).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent obtained.
    - Male or Female participant aged =18 years old.
    - Has ECOG performance status of 0, 1 or 2 at the time of the randomisation.
    - Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
    - RAS status must have been determined (mutant or wild).
    - Has at least one measurable metastatic lesion.
    - No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
    - Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is allowed only if it has been completed more than 6 months before start of study treatment.
    - Patient is not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection of metastatic lesions.
    - Is able to take medication orally (i.e., no feeding tube).
    - Has adequate organ function.
    - Coagulation parameters in normal limit. (or in therapeutic limit for patients treated with anticoagulant drugs).
    - Women of childbearing potential must have been tested negative in a serum pregnancy test.
    Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control. Women and female partners using hormonal contraceptive must also use a barrier method.
    - Is willing and able to comply with scheduled visits and study procedures.
    - Ottenimento del consenso informato scritto
    - Uomini o donne di età = 18 anni
    - Eastern Cooperative Oncology Group (ECOG) Performance Status di 0, 1 o 2 al momento della randomizzazione
    - Adenocarcinoma del colon o retto confermato istologicamente o citologicamente
    - Lo stato di RAS (mutante o wild type) deve essere stato determinato
    - Presenza di almeno una lesione misurabile metastatica
    - Nessuna precedente terapia antitumorale sistemica per il tumore colorettale metastatico non resecabile
    - Chemioterapia adiuvante ( o neoadiuvante per i pazienti con tumore rettale) precedente consentita solo se terminata da oltre sei mesi l’inizio del trattamento sperimentale
    -Il paziente non è candidabile per chemioterapia combinata con irinotecan o oxaliplatino, o per resezione curativa delle lesioni metastatiche
    - Capacità di assumere farmaci orali (ad esempio non i pazienti intubati)
    -Funzionalità adeguate degli organi
    -Parametri di coagulazione nella norma (o nei limiti terapeutici per i pazienti trattati con farmaci anticoagulanti)
    - Per le donne potenzialmente fertili, un test serico di gravidanza negativo prima dell’inizio dell'assunzione del farmaco in studio. I partecipanti donna con potenziale riproduttivo e i partecipanti uomini con partners con potenziale riproduttivo devono utilizzare un metodo contraccettivo altamente efficace.Donne o partner donne che stanno usando un contraccettivo ormonale, devono usare anche un metodo a barriera
    - Partecipante che desideri e sia in grado di aderire alle visite e procedure previste dallo studio.
    E.4Principal exclusion criteria
    - Foreseeable poor compliance to the study procedures.
    - Is a pregnant or lactating female.
    - Is inappropriate for entry into this study in the judgment of the Investigator.
    - Has certain serious illness or serious medical condition(s) described in the protocol.
    - Has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to randomisation.
    - Has previously received S 95005 or history of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.
    -Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
    - Has contra-indication to bevacizumab or capecitabine
    -Prevedibile scarsa compliance alle procedure dello studio
    - Donne in gravidanza o allattamento
    - Paziente considerato a giudizio dello sperimentatore non adatto a partecipare allo studio
    - Partecipante che presenti una patologia severa o condizioni cliniche severe descritte nel protocollo
    -Partecipanti che hanno ricevuto altri recenti trattamenti ad esempio interventi chirurgici maggiori, radioterapia su aree estese, che hanno ricevuto un farmaco sperimentale entro il periodo di tempo specificato prima della randomizzazione
    - Paziente a cui sia stato precedentemente somministrato S 95005 o con storia di reazioni allergiche attribuibili a componenti di composizione similare al S95005 o a qualsiasi dei suoi eccipienti.
    -Paziente con problemi rari ereditari di intolleranza al galattosio, deficienza al Lapp lactase o malasobimento del glucosio-galattosio.
    -Paziente con controindicazioni a bevacizumab o capecitabina.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS)
    Sopravvivenza libera da progressione
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumour measurements within 28 days prior to Day 1 of Cycle 1 and
    every 8 weeks thereafter.
    Misurazione tumorale entro i 28 giorni precedenti al giorno 1 del ciclo 1 e nelle 8 settimane successive
    E.5.2Secondary end point(s)
    Overall Response Rate (ORR). - Duration of Response (DR) ­ - Disease control rate (DCR) ­- Overall Survival ­- Safety and tolerability assessed by: * Incidence of Adverse Events (AE). *Laboratory tests: haematology, blood biochemistry, coagulation, urinalysis. * Physical examination and performance status (ECOG). * Vital signs: blood pressure (BP), heart rate (HR), body temperature, respiration rate, body weight. * 12-leads ECG parameters. - Quality of Life assessed by a quality of life questionnaire. - Exploratory endpoints:Biomarkers using blood samples and archived tumour biopsy (if available).
    Tasso di risposta totale (ORR) - durata della risposta (DR) - Tasso di controllo della malattia (DCR) - Sopravvivenza totale - Sicurezza e tollerabilità verificato come: -- incidenza degli eventi avversi (AE) --test di laboratorio: ematologia, biochimica, coagulazione, analisi delle urine - -Esame fisico e performance status (ECOG) -- Segni vitali: pressione sanguigna (BP), frequenza cardiaca (HR), temperatura corporea, frequenza respiratoria, peso corporeo --parametri ECG - Qualità della vita verificata con un questionario della qualità della vita - obiettivi esploratori : biomarker, usando campioni di sangue e biopsie tumorali archiviate (se disponibili)
    E.5.2.1Timepoint(s) of evaluation of this end point
    -- ORR, DR, DCR: tumour measurements within 28 days prior to Day 1 of Cycle 1 and every 8 weeks thereafter. -Overall Survival: survival status obtained at scheduled 8-week intervals until patient death or and of the study -Adverse Events: all over the study. - Laboratory tests, physical exam, ECOG, vital signs: within 5 days prior randomisation, at the dose of C1D1, C1D15 (except for coagulation, physical exam, ECOG), Day 1 of subsequent cycles, Day 15 of subsequent cycles (only for vital signs), and haematology in the experimental arm) withdrawal visit. - Quality of life assessments: every 12 weeks. - Biomarkers measurements: blood samples collected at C1D1 and withdrawal visit.
    - ORR, DR,DCR: misurazione tumorale entro 28 giorni e prima del giorno 1 del ciclo 1 e successivamente ogni 8 settimane -sopravvivenza totale: stato di sopravvivenza ottenuto negli intervalli programmati di 8 settimane fino alla morte del paziente o alla fine dello studio - Eventi avversi: durante tutto lo studio -Test di laboratorio, esame fisico ECOG, segni vitali: entro i 5 giorni precedenti alla randomizzazione , al pre-dose di C1D1, C1D15 (ad eccezione della coagulazione, esame fisico, ECOG) , giorno 1 del ciclo successivo, giorno 15 dei cicli successivi (solo per i segni vitali e l’ematologia nel razzio sperimentale), ), visita di uscita dallo studio -Verifica della qualità della vita: ogni 12 settimane - Misurazione dei biomarker: campioni di sangue prelevati a C1D1 e alla visita d
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Belgium
    Brazil
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Russian Federation
    Spain
    United Kingdom
    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
    12 months after the follow-up start date of the last patient withdrawn. The end of the trial is not the LVLP as a follow-up period is planned in the trial to collect patients survival data after the patients withdrawal. It has been decided to terminate the trial 12 months after the follow-up start date of the last patient withdrawn as we will collect enough data to assess overall survival.
    12 mesi dopo la data di inizio del follow-up dell’ultimo paziente uscito dallo studio. La
    fine dello studio non corrisponde alla LVLS poiché il periodo di follow-up è pianificato
    nello studio al fine di raccogliere i dati di sopravvivenza dei pazienti dopo l’uscita dei
    pazienti dallo studio. E’ stato deciso di terminare lo studio 12 mesi dopo la data di
    inizio del follow-up dell’ultimo paziente uscito dallo studio così da raccogliere dati
    sufficienti a valutare la sopravvivenza totale.
    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 months0
    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 months0
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 150
    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 avrà accesso ad un appropriato supporto medico dal suo medico, il quale fornirà le migliori cure.
    Regole specifiche potranno essere seguite in alcuni paesi in accordo alle leggi locali.
    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 Decision2016-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
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