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    Summary
    EudraCT Number:2018-003553-19
    Sponsor's Protocol Code Number:IBCSG59-19/BIG18-02
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-003553-19
    A.3Full title of the trial
    A phase III open-label, multicenter, randomized trial of adjuvant palbociclib in combination with endocrine therapy versus endocrine
    therapy alone for patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer
    Studio di fase III in aperto, multicentrico e randomizzato sull’uso di palbociclib adiuvante in combinazione con terapia endocrina rispetto alla sola terapia endocrina
    in pazienti affetti/e da recidiva loco-regionale isolata positiva per i recettori ormonali / HER2-negativa del carcinoma mammario, già sottoposta a resezione.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III clinical trial, which tests the safety and efficacy of the combination of palbociclib and endocrine therapy to learn whether the combination of these drugs works for a specific form of breast cancer
    Studio di fase III per valutare l'efficacia e sicurezza della combinazione di palbociclib con la terapia endocrina per definire se questa combinazione è utile per una forma specifica di carcinoma mammario.
    A.3.2Name or abbreviated title of the trial where available
    POLAR
    POLAR
    A.4.1Sponsor's protocol code numberIBCSG59-19/BIG18-02
    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 SponsorINTERNATIONAL BREAST CANCER STUDY GROUP
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPFIZER
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO EUROPEO ONCOLOGIA
    B.5.2Functional name of contact pointUFFICIO STUDI CLINICI ED ATTIVITA'
    B.5.3 Address:
    B.5.3.1Street AddressVIA ADAMELLO 16
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20139
    B.5.3.4CountryItaly
    B.5.4Telephone number02574898
    B.5.6E-mailufficio.studiclinici@ieo.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 IBRANCE - 125 MG - CAPSULA RIGIDA - USO ORALE - BLISTER (PVC/PCTFE/PVC/AL) - 21 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameIBRANCE
    D.3.2Product code [PD-0332991-00]
    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 INNPalbociclib
    D.3.9.2Current sponsor codePD-0332991-00
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 IBRANCE - 75 MG - CAPSULA RIGIDA - USO ORALE - BLISTER (PVC/PCTFE/PVC/AL) - 21 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameIBRANCE
    D.3.2Product code [PD-0332991-00]
    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 INNPalbociclib
    D.3.9.2Current sponsor codePD-0332991-00
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 IBRANCE - 100 MG - CAPSULA RIGIDA - USO ORALE - BLISTER (PVC/PCTFE/PVC/AL) - 21 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameIBRANCE
    D.3.2Product code [PD-0332991-00]
    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 INNPALBOCICLIB
    D.3.9.2Current sponsor codePD-0332991-00
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer
    Pazienti di sesso femminile o maschile con conferma istologica di recidiva loco-regionale HR-positiva / HER2-negativa isolata di un carcinoma mammario, sottoposta a resezione.
    E.1.1.1Medical condition in easily understood language
    Patients with breast cancer in the operated breast, the surgical scar, the chest wall or the regional lymph nodes
    Paziernti con ricomparsa del tumore della mammella nel seno operato, nella cicatrice chirurgica, nella parete toracica oppure nei linfonodi regionali
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether treatment with 3 years of palbociclib plus standard endocrine therapy for at least 3 years prolongs invasive disease free survival (iDFS compared) to treatment with standard endocrine therapy alone for at least 3 years
    in patients with HR-positive / HER2-negative resected isolated locoregional recurrence (ILRR) of breast cancer.
    Determinare se un trattamento con palbociclib e terapia endocrina standard per almeno 3 anni prolunghi la sopravvivenza libera da malattia invasiva (iDFS) rispetto al trattamento con sola terapia endocrina standard per almeno 3 anni in pazienti con recidiva loco-regionale isolata (ILRR) HR-positiva / HER2-negativa di carcinoma mammario già sottoposta a resezione.
    E.2.2Secondary objectives of the trial
    To assess the tolerability of 3 years of palbociclib in combination with standard endocrine therapy compared to standard endocrine therapy alone, as measured by adverse events.
    To assess whether treatment with 3 years of palbociclib plus standard endocrine therapy for at least 3 years prolongs other measures of efficacy as compared to treatment with standard endocrine therapy alone for at least 3 years in this patient population.
    Valutare la tollerabilità su 3 anni di palbociclib in combinazione con la terapia endocrina standard rispetto alla sola terapia endocrina standard, attraverso il rilevamento degli eventi avversi.
    Valutare se un trattamento con palbociclib in combinazione con la terapia endocrina standard per almeno 3 anni modifichi altri criteri di efficacia rispetto al trattamento con terapia endocrina standard da sola, per almeno 3 anni, in questa specifica popolazione di pazienti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed invasive breast cancer, defined as first proven ipsilateral local and/or regional recurrence in at least one of the sites below:
    – Breast
    – Chest wall including mastectomy scar and/or skin
    – Axillary or internal mammary lymph nodes
    - Completion of locoregional therapy:
    – Completion of gross excision of recurrence within 6 months prior to randomization
    – Completion of radiotherapy (if given) more than 2 weeks prior to randomization
    - Negative or microscopically involved margins
    - Female or male aged 18 years or older
    - ECOG performance status 0 or 1
    - Recurrent tumor must be hormone receptor positive: ER+ and/or PgR+ =1% by IHC
    - Recurrent tumor must be HER2-negative (0, 1+, 2+ by IHC and/or ISH/FISH not amplified)
    - Tumor with HER2 status 2+ by IHC must also be negative (not amplified) by ISH/FISH
    - Normal hematological, renal, and liver function
    - The patient agrees to make tumor (diagnostic core biopsy or surgical specimen of ILRR) available for submission for central pathology review
    - Patients must either be planned to initiate, or have already started, endocrine therapy for ipsilateral isolated locoregional recurrence
    - Written Informed Consent (IC) prior to randomization
    - Carcinoma mammario invasivo istologicamente confermato, definito come prima recidiva confermata ipsilaterale, locale e/o regionale, in almeno uno dei seguenti siti:
    – Seno
    – Parete toracica, incluso il tessuto cicatriziale della mastectomia e/o la pelle
    – Linfonodi ascellari o mammari interni
    - Completamento della terapia loco-regionale:
    – Completamento dell’escissione della recidiva entro 6 mesi prima della randomizzazione
    – Completamento della radioterapia (se prevista) oltre 2 settimane prima della randomizzazione
    - Margini negativi o con coinvolgimento microscopico
    - Pazienti di sesso maschile o femminile di età pari o superiore a 18 anni
    - Status funzionale ECOG pari a 0 o 1
    - La recidiva del tumore deve essere positiva per i recettori ormonali ER+ e/o PgR+ =1% tramite immunoistochimica (IHC)
    - La recidiva del tumore deve essere HER2-negativa (0, 1+, 2+ tramite IHC e/o ibridazione in situ (ISH) / ibridazione fluorescente in situ (FISH), non amplificato)
    Tumore con status HER2 2+ tramite immunoistochimica (IHC) ma anche negativo (non amplificato) tramite ibridazione in situ (ISH) / ibridazione fluorescente in situ (FISH)
    - Funzioni ematica, renale ed epatica normali
    - Il/la paziente accetta che il proprio tumore (prelevato tramite biopsia diagnostica o in forma di campione chirurgico della recidiva ILRR) possa essere sottoposto a un’analisi patologica a livello centrale.
    - I pazienti devono essere attualmente sottoposti o in attesa di una terapia endocrina contro una recidiva isolata ipsilaterale e loco-regionale
    - Consenso informato (CI) scritto prima della randomizzazione
    E.4Principal exclusion criteria
    - Recurrence of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules) not surgically removable
    - Evidence of distant metastasis as based on conventional staging examinations (physical, chest X-ray or CT, abdominal ultrasound or CT, bone scintigraphy or FDG-PET-CT).
    - Bilateral invasive breast cancer (in situ carcinoma of the contralateral breast is allowed)
    - Inflammatory breast cancer
    - Patients with a history of malignancy, other than invasive breast cancer, with the following exceptions:
    – Patients diagnosed, treated and disease-free for at least 5 years and deemed by the investigator to be at low risk for recurrence of that malignancy are eligible
    – Patients with the following malignancies are eligible, even if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast; cervical cancer in situ; thyroid cancer in situ; non-metastatic, non-melanomatous skin cancers
    - Previous treatment with palbociclib or any other CDK 4/6 inhibitors
    - Previous or planned chemotherapy or planned radiotherapy for the ipsilateral isolated locoregional recurrence (radiotherapy is allowed, but must be completed more than 2 weeks prior to randomization)
    - Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety
    - Contraindications or known hypersensitivity to the palbociclib or excipients
    - Pregnant or lactating women; lactation has to stop before randomization
    - Recidiva di qualsiasi dimensione con estensione diretta nella parete toracica e/o nella pelle (ulcere o noduli cutanei) non idonea alla rimozione chirurgica
    - Evidenze di metastasi a distanza identificate tramite esami convenzionali di stadiazione (visita medica, radiografia o TAC toracica, ecografia o TAC addominale, scintigrafia ossea o PET/TAC con FDG).
    - Carcinoma mammario invasivo bilaterale (incluso anche il carcinoma in situ nel seno controlaterale)
    - Carcinoma mammario infiammatorio
    - Pazienti con anamnesi di tumori maligni diversi dal carcinoma mammario invasivo, con le seguenti eccezioni:
    – Pazienti che hanno ricevuto una diagnosi di tumore, trattati e liberi dalla malattia per almeno 5 anni e ritenuti a basso rischio di recidiva di tale tumore maligno dal ricercatore
    – I pazienti con i seguenti tumori maligni, anche se diagnosticati e trattati negli ultimi 5 anni: carcinoma duttale in situ della mammella, carcinoma della cervice in situ, carcinoma della tiroide in situ, carcinomi cutanei non metastatici e non melanomatosi
    - Precedente trattamento con palbociclib o altri inibitori delle CDK 4/6
    - Chemioterapia pregressa o prevista oppure radioterapia prevista per la recidiva loco-regionale isolata ipsilaterale (la radioterapia è ammessa ma deve terminare oltre 2 settimane prima della randomizzazione)
    - Malattia concomitante a causa della quale il/la paziente non è idoneo/a a partecipare allo studio e altri disturbi medici gravi che possono mettere a rischio la sicurezza del/la paziente
    - Controindicazioni o ipersensibilità nota a palbociclib o agli eccipienti
    - Donne in gravidanza o allattamento; l’allattamento deve essere interrotto prima della randomizzazione
    E.5 End points
    E.5.1Primary end point(s)
    Invasive disease-free survival (iDFS)
    iDFS: is defined as the time from randomization until first appearance of invasive local, regional, or distant recurrence
    Sopravvivenza libera da malattia invasiva (iDFS).
    L’endpoint primario iDFS è definito come il tempo trascorso dalla randomizzazione fino alla prima insorgenza di recidive locali, loco-regionali o a distanza (incluse le recidive ipsilaterali e invasive di carcinoma mammario), di carcinoma mammario controlaterale invasivo, di un secondo carcinoma (non mammario) invasivo o del decesso dovuto a qualsiasi causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For the experimental arm every month for the first 3 months and afterwards every 3 months for 3 years.
    For the reference arm every 3 months for 3 years
    Per il braccio sperimentale ogni mese per i primi 3 mesi e poi ogni 3 mesi per 3 anni.
    Per il braccio di riferimento ogni 3 mesi per 3 anni
    E.5.2Secondary end point(s)
    - Tolerability: Adverse events; Breast cancer-free interval (BCFI); Distant recurrence-free interval (DRFI); Overall survival (OS)
    Tollerabilità: eventi avversi; Intervallo libero da carcinoma mammario (BCFI); Intervallo libero da recidive a distanza (DRFI); Sopravvivenza globale (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the experimental arm every month for the first 3 months and afterwards every 3 months for 3 years.
    For the reference arm every 3 months for 3 years; For the experimental arm every month for the first 3 months and afterwards every 3 months for 3 years and then every 6 months until first appearance of recurrence.
    For the reference arm every 3 months for 3 years, and then every 6 months until first appearance of recurrence.; For the experimental arm every month for the first 3 months and afterwards every 3 months for 3 years and then every 6 months until first appearance of distant recurrence.
    For the reference arm every 3 months for 3 years, and then every 6 months until first appearance of distant recurrence.; from randomization until death from any cause
    Per il braccio sperimentale ogni mese per i primi 3 mesi e poi ogni 3 mesi per 3 anni.
    Per il braccio di riferimento ogni 3 mesi per 3 anni; Per il braccio sperimentale ogni mese per i primi 3 mesi e poi ogni 3 mesi per 3 anni, quindi ogni 6 mesi fino alla comparsa di recidiva
    Per il braccio di riferimento ogni 3 mesi per 3 anni, quindi ogni 6 mesi fino alla comparsa di recidiva; Per il braccio sperimentale ogni mese per i primi 3 mesi e poi ogni 3 mesi per 3 anni, quindi ogni 6 mesi fino alla comparsa di recidiva a distanza
    Per il braccio di riferimento ogni 3 mesi per 3 anni, quindi ogni 6 mesi fino alla comparsa di recidiva a distanza; dalla randomizzazione fino al decesso per qualsiasi causa
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Austria
    France
    Hungary
    Italy
    Spain
    Switzerland
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state149
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 370
    F.4.2.2In the whole clinical trial 400
    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)
    STANDARD CARE
    TRATTAMENTO STANDARD
    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 Decision2019-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
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