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    Summary
    EudraCT Number:2017-004690-14
    Sponsor's Protocol Code Number:NA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 number2017-004690-14
    A.3Full title of the trial
    RECHALLENGE WITH PEGYLATED LIPOSOMAL DOXORUBICIN ADDED TO TRABECTEDIN IN RECURRENT OVARIAN CANCER: A MULTICENTER, PROSPECTIVE TRIAL (REPRAB study – MITO 36)
    RECHALLENGE CON DOXORUBICINA LIPOSOMALE PEGILATA IN AGGIUNTA ALLA TRABECTEDINA NELLA RECIDIVA DI TUMORE OVARICO: STUDIO PROSPETTICO MULTICENTRICO (REPRAB study – MITO 36)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RECHALLENGE WITH PEGYLATED LIPOSOMAL DOXORUBICIN ADDED TO TRABECTEDIN IN RECURRENT OVARIAN CANCER: A MULTICENTER, PROSPECTIVE TRIAL (REPRAB study – MITO 36)
    RECHALLENGE CON DOXORUBICINA LIPOSOMALE PEGILATA IN AGGIUNTA ALLA TRABECTEDINA NELLA RECIDIVA DI TUMORE OVARICO: STUDIO PROSPETTICO MULTICENTRICO (REPRAB study – MITO 36)
    A.3.2Name or abbreviated title of the trial where available
    REPRAB study – MITO 36
    Studio REPRAB – MITO 36
    A.4.1Sponsor's protocol code numberNA
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    B.1.3.4CountryItaly
    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 supportPharma Mar S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDirezione Scientifica Policlinico Universitario Agostino Gemelli IRCCS
    B.5.2Functional name of contact pointDirezione Scientifica Policlinico U
    B.5.3 Address:
    B.5.3.1Street AddressLargo A. Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number+390630155701
    B.5.5Fax number+390630155701
    B.5.6E-maildirezione.scientifica@policlinicogemelli.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 YONDELIS - 025 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO- FLACONCINO (VETRO) 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderPHARMA MAR S.A.
    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 nameTrabectedin
    D.3.2Product code [0]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 code0
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1
    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 CAELYX - 2 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO 10 ML USO EV
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL N.V.
    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 nameCaelyx
    D.3.2Product code [0]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 code0
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number30
    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
    Ovarian cancer
    Carcinoma ovarico
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    Tumore dell'ovaio
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10026311
    E.1.2Term Malignant neoplasm of ovary and other uterine adnexa
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061535
    E.1.2Term Ovarian neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061344
    E.1.2Term Peritoneal neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that rechallenge with pegylated liposomal doxorubicin (PLD) with the combination of trabectedin (Yondelis®) is active (objective response rate) in relapsed ovarian cancer patients who have already received pegylated liposomal doxorubicin and progress within 6-12 months after the end of last platinum or in fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments
    Dimostrare che il rechallenge con la combinazione doxorubicina liposomiale pegilata (PLD) e trabectedina (Yondelis®) è attivo (tasso di risposta obiettiva) nelle pazienti con recidiva di carcinoma ovarico che hanno già ricevuto PLD ed hanno recidivato entro 6-12 mesi dalla fine dell’ultimo platino o oltre 12 mesi dall’ultimo platino e non sono in grado di ricevere o non sono disposte a ricevere altri trattamenti al platino.
    E.2.2Secondary objectives of the trial
    • Traslational end point*: to define the correlation between genetic assessment, including BRCA1/2 genes, and Epithelial ovarian cancer (EOC) treatment and prognosis and to investigate how genetic pattern evolves over treatments
    • To analyze safety profile, progression free survival (PFS), overall survival (OS), following retreatment with trabectedin and PLD.
    • To evaluate the time from enrollment to subsequent chemotherapy and the overall survival counted from the administration of subsequent chemotherapy.
    • Duration of Response
    • Clinical benefit rate at 24 week
    • To evaluate serological response of CA-125.
    • To analyze the quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30) and the Quality of Life Questionnaire-OV28 (QLQ-OV28)
    *Only selected centre will participate to this endpoint
    • Endpoint traslazionale *: definire la correlazione tra valutazione genetica, inclusi i geni BRCA1/2, trattamento e prognosi nel carcinoma ovarico epiteliale (EOC) e valutare come il modello genetico si evolve nel corso dei trattamenti.
    • Analizzare il profilo di sicurezza, la sopravvivenza libera da progressione (PFS), la sopravvivenza globale (OS), del trattamento ripetuto con trabectedina e PLD.
    • Valutare il tempo di inizio alla successiva chemioterapia e la sopravvivenza globale dalla somministrazione della successiva linea.
    • Durata della Risposta
    • Tasso di beneficio clinico a 24 settimane
    • Valutare la risposta sierologica del CA-125.
    • Analizzare la qualità di vita (QoL) utilizzando the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30) and the Quality of Life Questionnaire-OV28 (QLQ-OV28)
    * Solo i centri selezionati parteciperanno a questo endpoint
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: 12.0
    Date: 23/03/2020
    Title: RECHALLENGE WITH PEGYLATED LIPOSOMAL DOXORUBICIN ADDED TO TRABECTEDIN IN RECURRENT OVARIAN CANCER: A MULTICENTER, PROSPECTIVE TRIAL. (REPRAB study- MITO 36)
    Objectives: to define the correlation between genetic assessment, including BRCA1/2 genes, and Epithelial ovarian cancer (EOC) treatment and prognosis and to investigate how genetic pattern evolves over treatments

    Life quality
    Version: 12.0
    Date: 23/03/2020
    Title: RECHALLENGE WITH PEGYLATED LIPOSOMAL DOXORUBICIN ADDED TO TRABECTEDIN IN RECURRENT OVARIAN CANCER: A MULTICENTER, PROSPECTIVE TRIAL. (REPRAB study- MITO 36)
    Objectives: To analyze the quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30) and the Quality of Life Questionnaire-OV28 (QLQ-OV28)

    Farmacogenetica
    Versione: 12.0
    Data: 23/03/2020
    Titolo: RECHALLENGE CON DOXORUBICINA LIPOSOMALE PEGILATA IN AGGIUNTA ALLA TRABECTEDINA NELLA RECIDIVA DI TUMORE OVARICO: STUDIO PROSPETTICO MULTICENTRICO (REPRAB study – MITO 36).
    Obiettivi: definire la correlazione tra valutazione genetica, inclusi i geni BRCA1/2, trattamento e prognosi nel carcinoma ovarico epiteliale (EOC) e valutare come il modello genetico si evolve nel corso dei trattamenti.

    Qualita' della vita
    Versione: 12.0
    Data: 23/03/2020
    Titolo: RECHALLENGE CON DOXORUBICINA LIPOSOMALE PEGILATA IN AGGIUNTA ALLA TRABECTEDINA NELLA RECIDIVA DI TUMORE OVARICO: STUDIO PROSPETTICO MULTICENTRICO (REPRAB study – MITO 36).
    Obiettivi: Analizzare la qualità di vita (QoL) utilizzando the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30) and the Quality of Life Questionnaire-OV28 (QLQ-OV28)
    E.3Principal inclusion criteria
    • Female aged = 18 years
    • Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
    • Partially platinum sensitive patients or fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments, who have previously received PLD(carboplatin-pegylated liposomal doxorubicin or pegylated liposomal doxorubicin alone).
    • ECOG PS 0-1.
    • Subject has radiographically-documented measurable disease, as per RECIST 1.1 at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression).
    • Be able to receive IV dexamethasone or an equivalent IV corticosteroid.
    • Have all of the following: hemoglobin =9 g/dL (without transfusion in the prior 7 days).
    Subjects may be enrolled into the study while receiving recombinant erythropoietin provided they have received recombinant erythropoietin for at least 4 weeks before the first dose of study drug. albumin >25 g/L absolute neutrophil count (ANC) >1,500/µL platelet count >100,000/µL (without transfusion in the prior 7 days) either a serum creatinine <=1.5 mg/dL or a calculated glomerular filtration rate
    >60 mL/min/1.73 m2 (Cockcroft-Gault) CPK <2.5 x upper limit of normal (ULN)
    • Have total bilirubin <xULN. If total bilirubin is > 1,5xULN, measure direct and indirect bilirubin to evaluate for Gilbert’s syndrome (if direct bilirubin is within normal range, subject may be eligible).
    • Have alkaline phosphatase (ALP) <=2.5xULN; if the ALP is >2.5xULN, then an ALP liver
    fraction or 5' nucleotidase must be <ULN (as reported in absolute units of measure).
    • Have AST and ALT <=2.5xULN.
    • Have LVEF by MUGA scan or 2D-ECHO within normal limits for the institution.
    • Patients with child-bearing potential using (or willing to use) effective contraception during treatment and 3 months ahead unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically
    • Evidence of not pregnancy status as documented by a negative beta-human chorionic gonadotropin (ß-hCG) test
    • Not breastfeeding women
    • Adequate recovery from acute toxicity of any prior treatment
    • Età = 18 anni
    • Diagnosi istologica o citologica documentata di carcinoma ovarico epiteliale invasivo, carcinoma peritoneale primario o carcinoma delle tube di Falloppio
    • Pazienti parzialmente sensibili al platino o completamente sensibili al platino che non sono in grado o non sono disposti a ricevere altri trattamenti aa base di platino, e che hanno precedentemente ricevuto doxorubicina liposomiale pegilata (in associazione con carboplatino o da sola).
    • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
    • Le pazienti all'ingresso nello studio deve avere malattia misurabile documentata radiograficamente, come da criteri RECIST 1.1 (l'aumento del CA-125 non supportato dall'evidenza radiologica di malattia non è accettato come criterio per definire la progressione).
    • La paziente deve poter assumere desametasone endovena o altro corticosteroide equivalente.
    • I seguenti parametri devono essere rispettati:
    • emoglobina > 9 g/dL (senza trasfusioni nei 7 giorni precedenti). I soggetti possono essere arruolati nello studio durante il trattamento con eritropoietina a condizione che abbiano ricevuto l’ultima dose 4 settimane prima della prima dose del farmaco in studio.
    • albumina >25 g/L
    • Valore assoluto dei neutrofili (ANC) >1,500/µL
    • conta piastrinica >100,000/µL (senza trasfusioni nei 7 giorni precedenti)
    • creatinina sierica <=1.5 mg/dL o un indice di filtrazione glomerulare >60 mL/min/1.73 m2 (Cockcroft-Gault)
    • CPK <2.5 x limite superiore normale (ULN)
    • Bilirubina totale <1.5 xULN. Se la bilirubina totale > 1,5xULN, eseguire dosaggio della bilirubina diretta e indiretta per valutare diagnosi di Sindrome di Gilbert (se la bilirubina diretta è normale, il soggetto può entrare nello studio).
    • Fosfatasi alcalina (ALP) <=2.5xULN
    • AST e ALT <=2.5xULN.
    • LVEF valutata tramite MUGA o 2D-ECO entro il valore normale
    • Le pazienti non devono avere potenziale riproduttivo quindi verranno arruolate solo pazienti in postmenopausa (almeno 12 mesi consecutivi di amenorrea, nella fascia di età appropriata e senza altra causa nota o sospetta), o sottoposte a sterilizzazione chirurgica.
    • Recupero adeguato della tossicità acuta di qualsiasi trattamento precedente
    E.4Principal exclusion criteria
    • Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
    • Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months from the last dose of platinum
    • Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
    • Known hypersensitivity to any of the components of PLD or trabectedin i.v. formulation
    • Previous treatment with Trabectedin
    • Known hypersensitivity to dexamethasone
    • Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy.
    • History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer
    • Myocardial failure within six months before enrolment, New York Heart Association (NYHA) Class II or worse heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
    • Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential subjects who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy). Also known history of liver carcinoma and cholangitis with abnormal liver functionality
    • Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
    • Breastfeeding women
    • Pregnant women
    • Known clinically relevant CNS metastases
    • Psychiatric disorder that prevents compliance with protocol
    • Patients with concurrent serious or uncontrolled infection
    • Patients in need of yellow fever vaccine while on study chemotherapy
    • Active infection
    • Any other unstable medical condition
    • Tumori ovarici non epiteliali o misti (ad es. Tumori mulleriani)
    • Pazienti che non hanno risposto all'ultima terapia a base di platino o con recidiva <6 mesi dall'ultima dose di platino
    • Occlusione intestinale, malattia subocclusiva o presenza di metastasi cerebrali sintomatiche
    • Ipersensibilità nota a uno dei componenti in studio (doxorubicina liposomiale pegilata o TRABECTEDINA)
    • Precedente trattamento con Trabectedina
    • Ipersensibilità conosciuta al desametasone
    • Meno di 4 settimane dall'ultima dose di terapia con qualsiasi agente sperimentale o chemioterapico.
    • Anamensi positiva per altra malattia neoplastica (tranne il carcinoma a cellule basali o il carcinoma cervicale in situ adeguatamente trattato) a meno che non sia in remissione da più di 3 anni.
    • Insufficienza miocardica nei sei mesi prima dell'arruolamento, insufficienza cardiaca di classe > II secondo la New York Heart Association (NYHA), angina incontrollata, aritmie ventricolari non controllate gravi, malattia pericardica clinicamente significativa o evidenza elettrocardiografica di ischemia acuta o di anomalie del sistema di conduzione in fase attiva.
    • Malattia epatica cronica significativa nota, come cirrosi o epatite attiva (sono consentiti soggetti che risultano positivi all'antigene di superficie dell'epatite B o agli anticorpi dell'epatite C purché non abbiano una malattia attiva che richiede una terapia antivirale). Storia nota anche di carcinoma epatico e colangite con funzionalità epatica anormale
    • Gravi problemi medici concomitanti o qualsiasi condizione medica instabile non correlata alla neoplasia, che limiterebbero in modo significativo la piena partecipazione del paziente allo studio o esporrebbero il paziente a un rischio elevato o a una riduzione dell'aspettativa di vita
    • Metastasi del SNC clinicamente sintomatiche
    • Disordini psichiatrici che potrebbero influenzare la partecipazione del paziente al protocollo di studio
    • Pazienti con infezioni in fase attiva
    • Donne in gravidanza
    • Donne che allattano al seno
    • Pazienti che necessitano di un vaccino contro la febbre gialla durante lo studio
    • Altre condizioni mediche gravi
    E.5 End points
    E.5.1Primary end point(s)
    Response and progression will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
    Tasso di risposta e progressione valutate secondo RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 concerned14
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-05-24. Yes
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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 clinical practice
    Normale pratica clinica
    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 Decision2021-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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