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    Summary
    EudraCT Number:2016-001962-27
    Sponsor's Protocol Code Number:ACT14884
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    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 number2016-001962-27
    A.3Full title of the trial
    Open-label Phase 2 study evaluating efficacy and safety of SAR566658 treatment in patients with CA6 positive metastatic Triple Negative Breast Cancer
    Studio di fase 2, in aperto, per la valutazione dell¿efficacia e della sicurezza del trattamento con SAR566658 in pazienti con tumore alla mammella triplo negativo metastatico CA6 positivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients with CA6 Positive Metastatic Triple Negative Breast Cancer
    Studio per la valutazione dell¿efficacia e della sicurezza del trattamento con SAR566658 in pazienti con tumore alla mammella triplo negativo metastatico CA6 positivo
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberACT14884
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1182-7044
    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 SponsorSANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
    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 supportSanofi-aventis recherche & d¿veloppement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi S.p.A.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressViale Luigi Bodio, 37/b
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800226343
    B.5.5Fax number00390239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSAR566658
    D.3.2Product code SAR5666658
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSAR566658
    D.3.9.4EV Substance CodeSUB31263
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 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: 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 PeIMP-principio attivo: Feniramina maleato g 0,30 + Tetrizolina cloridrato g 0,05
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    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 Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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 PeIMP-principio attivo: desametasone 0.15% (gel oftalimco)
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    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 Eye gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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: 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 peIMP-principio attivo: cetirizina
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    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.3.11 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
    Cancer
    Tumore
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    Tumore alla mammella
    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 PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative breast 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
    To select in the first part the SAR566658 dose based on Objective Response Rate (ORR) and safety of 2 dose levels and to demonstrate in the second part the efficacy of the selected dose based on ORR.
    Selezionare nella 1a parte la dose di SAR566658 sulla base del tasso di risposta obiettiva (ORR) e della sicurezza tra i 2 dosaggi e dimostrare nella 2a parte l'efficacia della dose selezionata sulla base di ORR
    E.2.2Secondary objectives of the trial
    - To assess:
    - Disease Control Rate (DCR), Duration Of Response (DOR), Progression-Free Survival (PFS), and Time To Progression (TTP) ;
    - The PK profile of SAR566658
    - The impact of ocular primary prophylaxis on the incidence of keratopathies ;
    - The potential immunogenicity of SAR566658 ;
    - The relationship between CA6 expression level in the tumor, and circulating CA6 in
    blood at baseline, and efficacy outcomes
    - To evaluate the global safety profile.
    ¿ Valutare:
    - Il tasso di controllo della malattia (Disease Control Rate, DCR), la durata della risposta (Duration Of Response, DOR), la sopravvivenza libera da progressione (Progression-Free Survival, PFS) e il tempo di progressione (Time To Progression, TTP),
    - Il profilo farmacocinetico (PK) di SAR566658,
    - L¿impatto della profilassi oculare primaria sull¿incidenza delle cheratopatie,
    - L¿immunogenicit¿ potenziale di SAR566658,
    - La relazione tra i livelli di espressione di CA6 nel tumore e il CA6 circolante nel sangue al basale e i risultati di efficacia.
    ¿ Valutare il profilo di sicurezza complessivo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Measurable Metastatic triple negative breast cancer (TNBC).
    -Patients with CA6-positive disease.
    -Patients received at least 1 prior chemotherapy regimen but no more than 3 for advanced/metastatic disease.
    -Prior anticancer therapy must have contained anthracycline (eg, doxorubicin), if not contraindicated, and a taxane (eg, docetaxel, paclitaxel) in an adjuvant/neo-adjuvant or metastatic setting.
    - Tumore alla mammella triplo negativo (TNBC) metastatico, con malattia misurabile
    - Pazienti con malattia CA6 positiva
    - Pazienti che abbiano ricevuto precedentemente almeno 1 regime chemioterapico, ma non più di 3, per malattia in stato avanzato/metastatico
    - Precedente terapia antitumorale contenente antracicline (ad es. doxorubicina), se non controindicata, e un taxano (ad es. docetaxel, paclitaxel) in contesto adiuvante/neo-adiuvante o metastatico
    E.4Principal exclusion criteria
    -Eastern Cooperative Oncology Group (ECOG) performance status =2.
    -Patient less than 18 years old.
    -Pregnant or breast-feeding women.
    -Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and for 6 months following discontinuation of study drug.
    -Wash out period of less than 3 weeks or 5 half-lives from previous antitumor chemotherapy, immunotherapy, or any investigational treatment.
    -History of brain metastasis (other than totally resected or previously irradiated and nonprogressive/relapsed), spinal cord compression or carcinomatous meningitis, or new evidence of brain leptomeningeal disease.
    -Prior treatment with eribulin as last prior therapy or prior maytansinoid treatments (DM1 or DM4 antibody-drug conjugates [ADCs]).
    -Known intolerance to infused protein products including other monoclonal antibodies and ADCs.
    -Poor bone marrow reserve and/or poor organ function.
    -Symptomatic peripheral neuropathy Grade =2.
    -Previous history of chronic corneal diseases (even if asymptomatic) or unresolved acute nonrecurrent corneal conditions.
    -Patients wearing contact lenses who are not willing to stop wearing them for the duration of the study.
    -Medical conditions requiring concomitant administration of strong CYP3A4 inhibitors, unless it can be discontinued at least 2 weeks before 1st administration of SAR566658.
    -Contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid.
    - Eastern Cooperative Oncology Group (ECOG) performance status =2.
    - Pazienti di età inferiore a 18 anni.
    - Donne in gravidanza o che allattano al seno
    - Pazienti con potenziale riproduttivo che non acconsentono all’utilizzo di un metodo contraccettivo accettato ed efficace durante il periodo di trattamento dello studio e nei 6 mesi successivi l’interruzione del farmaco in studio
    - Periodo di wash-out inferiore a 3 settimane o a 5 emivite dalla precedente chemioterapia, immunoterapia o terapia antitumorale sperimentale
    - Anamnesi di metastasi cerebrali (escluse quelle totalmente resecate o precedentemente trattate con radioterapia e non progressive/recidivanti), compressione del midollo spinale o meningite carcinomatosa, o nuova evidenza di malattia cerebrale leptomeningea
    - Trattamento a base di eribulina come ultima terapia precedente o trattamenti precedenti a base di maitansinoidi (farmaci anticorpo-coniugati DM1 o DM4 [antibody-drug conjugates, ADC])
    - Intolleranza nota a prodotti proteici per infusione, compresi altri anticorpi monoclonali e ADC
    - Scarsa riserva di midollo osseo e/o scarza funzionalità d'organo
    - Neuropatia periferica sintomatica di Grado =2
    - Anamnesi di malattie corneali croniche (anche se asintomatiche) o malattie corneali acute, non ricorrenti o irrisolte
    - Pazienti portatori di lenti a contatto che non acconsentono ad interrompere l’utilizzo delle lenti durante il corso dello studio
    - Malattie che necessitano della somministrazione concomitante di potenti inibitori del CYP3A4, a meno che non possano essere interrotti almeno 2 settimane prima della 1ª somministrazione di SAR566658
    - Controindicazioni all’utilizzo di vasocostrittori oftalmici e/o corticosteroidi
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate
    Tasso di risposta obiettiva
    E.5.1.1Timepoint(s) of evaluation of this end point
    evaluation at 18 months
    valutazione a 18 mesi
    E.5.2Secondary end point(s)
    1/ Disease control rate
    2/ Duration of response - time
    3/ Progression free survival - time
    4/ Time to progression
    5/ Number of keratopathies
    6/ Incidence of positive patients for antidrug antibodies as a measure of SAR566658 immunogenicity
    1/ Tasso di controllo della malattia
    2/ Durata della risposta - tempo
    3/ Sopravvivenza libera da progressione - tempo
    4/ Tempo di progressione
    5/ Numero di cheratopatie
    6/ L'incidenza di pazienti positivi per gli anticorpi antiterapeutici come una misura dell¿immunogenecit¿ di SAR566658
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2 : at 18 months
    3-4 : at 2 years 5 : Up to 30 days after the 3-week treatment cycle(s) (until 30 days after last treatment administration) 6 : Up to 60 days after the 3-week treatment cycle(s) (until 60 days after last treatment administration)
    1-2: a 18 mesi
    3-4: a 2 anni
    5: fino a 30 giorni dopo le 3 settimane del/i ciclo/i di trattamento (fino a 30 giorni dopo l'ultima somministrazione del trattamento)
    6: fino a 60 giorni dopo le 3 settimane del/i ciclo/i di trattamento (fino a 60 giorni dopo l'ultima somministrazione di trattamento)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    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 years2
    E.8.9.1In the Member State concerned months4
    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 months4
    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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    F.4.2.2In the whole clinical trial 62
    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)
    None
    Nessuno
    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 Decision2016-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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