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    Summary
    EudraCT Number:2020-005106-25
    Sponsor's Protocol Code Number:D8241C00001
    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:2021-11-03
    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 number2020-005106-25
    A.3Full title of the trial
    A Modular Phase I/II, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD0466 Monotherapy or in Combination in Patients with Advanced Haematological Malignancies
    Studio modulare di fase I/II, in aperto, multicentrico per valutare la sicurezza, la tollerabilità, la farmacocinetica e l’efficacia preliminare di AZD0466 in monoterapia o in combinazione in pazienti con tumori maligni ematologici in stadio avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Safety, Tolerability, Pharmacokinetics of AZD0466 in Patients with Advanced Haematological Malignancies
    Studio di fase I/II di AZD0466 in monoterapia o in combinazione in pazienti con tumori maligni ematologici in stadio avanzato
    A.3.2Name or abbreviated title of the trial where available
    NIMBLE
    NIMBLE
    A.4.1Sponsor's protocol code numberD8241C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04865419
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.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 nameAZD0466 polvere per concentrato per soluzione per infusione
    D.3.2Product code [AZD0466]
    D.3.4Pharmaceutical form Powder and solvent for 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.3.8INN - Proposed INNAZD0466
    D.3.9.2Current sponsor codeAZD0466
    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.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.2.5The 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 nameRasburicase
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Powder and solvent for 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.3.8INN - Proposed INNRASBURICASE
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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 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.2.1.2Country 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 nameAllopurinolo
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form 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 INNALLOPURINOLO
    D.3.9.2Current sponsor codeNA
    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.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.2.5The 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 nameAllopurinolo
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form 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 INNALLOPURINOLO
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    Advanced Haematological Malignancies
    Tumori maligni ematologici in stadio avanzato
    E.1.1.1Medical condition in easily understood language
    Blood cancer
    Tumori ematologici
    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 LLT
    E.1.2Classification code 10007051
    E.1.2Term Cancer (NOS)
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of AZD0466 in patients with advanced haematological malignancies
    Valutare la sicurezza e la tollerabilità di AZD0466 in pazienti con tumori maligni ematologici in stadio avanzato
    E.2.2Secondary objectives of the trial
    To characterize the pharmacokinetic (PK) profile of AZD0466 following intravenous administration (via PK profiles of the active moiety AZD4320 in plasma) [Core Module]

    To estimate the preliminary antitumor activity of AZD0466 [Module 1]
    Caratterizzare il profilo faramacocinetico (PK) di AZD0466 in seguito a somministrazione endovenosa (tramite profili PK della frazione attiva AZD4320 nel plasma) [Modulo Core]

    Stimare l'attività preliminare antitumorale di AZD0466 [Module 1]
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient must be aged >=18 years inclusive, at the time of signing the informed consent. In some countries parental consent may be required in addition to an assent form for patients who are 18 years of age.
    -Histologically confirmed acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL) for which there are limited treatment options known to provide clinical benefit.
    -Subjects must have received at least one prior line of therapy, and an established standard of care with proven benefit, and for which the patient is eligible, must not be available at the time of enrolment.
    -Eastern Cooperative Oncology Group performance status <=2. Performance status must not have deteriorated by >=2 levels within 2 weeks after providing informed consent.
    -Predicted life expectancy >= 8 weeks.
    -White blood cell count must be <10 x 10^9/L. Treatment with hydroxyurea during screening and Cycle 1 to achieve this level is permitted.
    -Adequate organ function at screening as per the protocol defined criteria

    PLEASE REFER TO THE PROTOCOL FOR FURTHER INCLUSION CRITERIA
    -I pazienti devono avere un’età >=18 anni al momento della firma del consenso informato. In alcuni Paesi potrebbe essere richiesto il consenso dei genitori in aggiunta al modulo di assenso per i pazienti di 18 anni di età.
    - Leucemia mieloide acuta (LMA) o leucemia linfoblastica acuta (LLA) istologicamente confermata per la quale esistono opzioni terapeutiche limitate note per fornire un beneficio clinico.
    - I soggetti devono aver ricevuto almeno una precedente linea di terapia e uno standard
    di cura consolidato con beneficio dimostrato e per il quale il paziente è idoneo; non devono essere disponibili al
    momento dell’arruolamento.
    - Stato di validità secondo l’Eastern Cooperative Oncology Group (gruppo orientale cooperativo di oncologia) <=2. Lo stato di validità non deve essere peggiorato di >=2 livelli entro 2 settimane dopo aver fornito il consenso informato.
    - Aspettativa di vita prevista >=8 settimane.
    - La conta leucocitaria deve essere <10 x 10^9/l. È consentito il trattamento con idrossiurea durante lo screening e il Ciclo 1 per raggiungere questo livello.
    -Adeguata funzionalità d’organo allo screening secondo i criteri definiti dal protocollo.

    SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO PER ULTERIORI CRITERI DI INCLUSIONE
    E.4Principal exclusion criteria
    -Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events Grade >=2. Patients with Grade 2 neuropathy or Grade 2 alopecia are eligible.
    -Active idiopathic thrombocytopenic purpura.
    -Haemopoietic Stem cell transplant < 100 days prior to the first dose of study treatment.
    -Immunosuppression for graft versus host disease (GVHD) or GVHD prophylaxis within 4 weeks prior to the first dose of study treatment. The following are permitted: (a) topical steroids for GVHD; (b) systemic steroids for GVHD up to 2 weeks prior to the first dose of study treatment; (c) if systemic steroids are being used, they may be continued up until 2 days prior to the first dose of study treatment.
    -Active central nervous system (CNS) leukaemia/leptomeningeal disease/spinal cord compression. Patients who have a history of CNS leukaemia must be free of CNS leukaemia for >30 days prior to the first dose of study treatment, and the most recent 2 lumbar punctures must be negative for leukaemic cells, to be eligible. •Known uncontrolled infection with cytomegalovirus.
    -Active infection including human immunodeficiency virus, Hepatitis B,Hepatitis C, or severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
    -As judged by the Investigator: any evidence of severe or uncontrolledsystemic diseases; current unstable or uncompensated respiratory or cardiac conditions; uncontrolled hypertension; history of, or active, bleeding diatheses (eg, haemophilia or von Willebrand disease); uncontrolled active systemic fungal, bacterial, or other infection.

    PLEASE REFER TO THE PROTOCOL FOR FURTHER EXCLUSION CRITERIA
    -Tossicità non risolta da precedente terapia antitumorale dei Criteri terminologici comuni per gli eventi avversi di grado >=2. I pazienti con neuropatia di grado 2 o alopecia di grado 2 sono idonei.
    -Porpora trombocitopenica idiopatica attiva.
    -Trapianto di cellule staminali emopoietiche <100 giorni prima della prima dose di trattamento dello studio.
    -Immunosoppressione dovuta a malattia del trapianto contro l’ospite (GVHD) o profilassi della GVHD nelle 4 settimane precedenti la prima dose del trattamento dello studio. È consentito quanto segue: (a) steroidi topici per la GVHD; (b) steroidi sistemici per la GVHD fino a 2 settimane prima della prima dose del trattamento dello studio; (c) se vengono utilizzati steroidi sistemici, possono essere proseguiti fino a 2 giorni prima della prima dose del trattamento dello studio.
    -Leucemia attiva del sistema nervoso centrale (SNC)/malattia leptomeningea/compressione del midollo spinale. Per essere idonei, i pazienti che presentano un’anamnesi di leucemia del SNC devono essere liberi da leucemia del SNC da >30 giorni prima della prima dose di trattamento dello studio e le 2 punture lombari più recenti devono essere negative per le cellule leucemiche.
    -Nota infezione non controllata da citomegalovirus.
    -Infezione attiva, tra cui virus dell’immunodeficienza umana, epatite B, epatite C o sindrome respiratoria acuta grave-coronavirus-2 (SARS-CoV-2).
    -Secondo il giudizio dello sperimentatore: qualsiasi evidenza di malattie sistemiche gravi o non controllate, attuali condizioni respiratorie o cardiache instabili o non compensate, ipertensione non controllata, anamnesi o presenza di diatesi emorragiche (ad es., emofilia o malattia di von Willebrand) attive, infezione fungina, batterica o di altro tipo sistemica attiva non controllata.




    SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO PER ULTERIORI CRITERI DI ESCLUSIONE
    E.5 End points
    E.5.1Primary end point(s)
    • Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [Core Module]
    • Changes from baseline in laboratory findings, physical examinations, performance status, electrocardiograms and vital signs [Core Module]
    • Dose-limiting toxicity [Module 1]
    • Maximum tolerated dose [Module 1]
    • Recommended Phase II dose [Module 1]
    • Incidenza di EA e SAE
    • Variazioni rispetto al basale nei risultati di laboratorio, negli esami obiettivi, nello stato di validità, negli elettrocardiogrammi e nei segni vitali
    • Tossicità limitante la dose [Modulo 1]
    • Massima dose tollerata [Modulo 1]
    • Dose raccomandata Fase II [Modulo 1]
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Module 1 and Module 2: From Screening until post treatment follow-up (28 days after last dose);
    • Module 1: From Screening until post treatment follow-up (28 days after last dose); Module 2: From Screening until Day 19
    • Day 1 to Day 35 of Cycle 1 (35-day Cycle)
    • Day 1 to Day 35 of Cycle 1 (35-day Cycle)
    • Day 1 to Day 35 of Cycle 1 (35-day Cycle)
    • Modulo 1 e Modulo 2: Dallo Screening fino al follow-up post trattamento (28 giorni dopo l'ultima dose);
    • Modulo 1: Dallo Screening fino al follow-up post trattamento (28 giorni dopo l'ultima dose); Modulo 2: dallo screening fino al giorno 19
    • Dal giorno 1 al giorno 35 del ciclo 1 (ciclo di 35 giorni)
    • Dal giorno 1 al giorno 35 del ciclo 1 (ciclo di 35 giorni)
    • Dal giorno 1 al giorno 35 del ciclo 1 (ciclo di 35 giorni)
    E.5.2Secondary end point(s)
    • Plasma concentrations and derived PK parameters for total and released AZD4320
    • Complete Response Rate (CR+CRi); Time to Response (TTR); Duration of Response (DoR); Overall Survival (OS) [Module 1]
    • Area under the plasma concentration-curve (AUC) of AZD4320 after administration of AZD0466 alone and in combination with voriconazole [Module 2]; Maximum observed plasma (peak) drug concentration (Cmax) of AZD4320 after administration of AZD0466 alone and in combination with voriconazole [Module 2]
    • Concentrazioni plasmatiche e parametri PK derivati ¿¿per AZD4320 totale e rilasciato
    • Tasso di risposta completa (CR + CRi); Tempo di risposta (TTR); Durata della risposta (DoR); Sopravvivenza globale (OS) [Modulo 1]
    • Area sotto la curva di concentrazione plasmatica (AUC) di AZD4320 dopo somministrazione di AZD0466 da solo e in combinazione con voriconazolo [Modulo 2]; Massima concentrazione plasmatica (picco) del farmaco (Cmax) osservata di AZD4320 dopo la somministrazione di AZD0466 da solo e in combinazione con voriconazolo [Modulo 2]
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Module 1: Days 1 and 4, and days 8, 9, 10, 11 of Cycle 1;
    • Module 2: Days 1, 2, 3, 4, and 8 (Period 1) and days 15, 16, 17, 18, 19 (Period 3) during Cycle 1 (21 days)
    • Module 1: Day 1 until post treatment follow-up (28 days after last dose)
    • Module 2: Days 1, 2, 3, 4, and 8 (Period 1) and days 15, 16, 17, 18, 19 (Period 3) during Cycle 1 (21 days)
    • Modulo 1: giorni 1 e 4 e giorni 8, 9, 10, 11 del ciclo 1;
    • Modulo 2: giorni 1, 2, 3, 4 e 8 (periodo 1) e giorni 15, 16, 17, 18, 19 (periodo 3) durante il ciclo 1 (21 giorni)
    • Modulo 1: giorno 1 fino al follow-up post trattamento (28 giorni dopo l'ultima dose)
    • Modulo 2: giorni 1, 2, 3, 4 e 8 (periodo 1) e giorni 15, 16, 17, 18, 19 (periodo 3) durante il ciclo 1 (21 giorni)
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy
    Sicurezza, Tollerabilità, Farmacocinetica ed Efficacia Preliminare
    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 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 EEA16
    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
    Korea, Republic of
    United States
    France
    Germany
    Italy
    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
    The end of the study is defined as the date of the last visit of the last subject in the study or last scheduled procedure shown in the Schedule of Activity for the last subject in the study globally.
    La fine della sperimentazione è definita come la data dell'ultima visita dell'ultimo paziente nello studio o l'ultima procedura programmata mostrata nella scheda di attività dell'ultimo paziente nello studio a livello globale
    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 months7
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years4
    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: 152
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 160
    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)
    Not applicable
    Non applicabile
    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 Decision2022-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-07-24
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