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    Summary
    EudraCT Number:2013-000144-26
    Sponsor's Protocol Code Number:ABI-007-PST-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-20
    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 number2013-000144-26
    A.3Full title of the trial
    A Phase 1/2, multicenter, open-label, dose-finding study to assess the safety, tolerability, and
    preliminary efficacy of weekly nab-paclitaxel in pediatric patients with recurrent or refractory
    solid tumors.
    Studio di fase 1/2, multicentrico, in aperto, di definizione della dose, per una valutazione della sicurezza e della tollerabilità e una valutazione preliminare dell’efficacia di nab®-paclitaxel in soggetti in età pediatrica con tumori solidi recidivati o refrattari
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    clinical study for pediatric patients with solid tumors that have come back after disappearing or that don’t respond to any treatment, designed to find the safest and most tolerable dose of nab ®-paclitaxel and to asses the preliminary efficacy of the treatment.
    Studio clinico in pazienti pediatrici con tumori solidi scomparsi e riapparsi o che non rispondono a nessun trattamento, con lo scopo di trovare la dose più sicura e tollerabile di nab-paclitaxel e per valutare l’efficacia preliminare del trattamento
    A.4.1Sponsor's protocol code numberABI-007-PST-001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/116/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbraxis BioScience, LLC, a wholly-owned subsidiary Celgene Corporation
    B.1.3.4CountryUnited States
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9900 W. 109th Street, Building 70, Suite 300
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1-888-260-1599
    B.5.5Fax number+1 913-451-3459
    B.5.6E-mailClinicalTrialDisclosure@celgene.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 Yes
    D.2.1.1.1Trade name Abraxane
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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.3.2Product code nab-paclitaxel, ABI-007
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.2Current sponsor codeABI-007
    D.3.9.4EV Substance CodeSUB09583MIG
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeThe IMP contains an excipient of biological origin, albumin, a non-active stabilising agent. It is derived from human blood subject to approved donor screening and product manufacturing processes.
    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
    recurrent or refractory solid tumor
    Tumori solidi ricorrenti o refrattari
    E.1.1.1Medical condition in easily understood language
    subjects with solid tumors that have come back after disappearing or that don’t respond to any treatment
    Pazienti pediatrici con tumori solidi scomparsi e riapparsi o che non rispondono a nessun trattamento
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    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
    Phase I:
    determine the pediatric MTD/RP2D, safety and tolerability of nab-paclitaxel administered intravenously over 30min on Days 1, 8, and 15 of a 28-day cycle in patients ≥ 6 months and < 18 years old with recurrent or refractory solid tumors

    Phase II:
    assess the antitumor activity by the overall response rate (ORR) of nab-paclitaxel given at the RP2D in patients ≥ 6 months and ≤ 21 years old with several discrete recurrent or refractory solid tumor types such as
    neuroblastoma, rhabdomyosarcoma, and a mixed solid tumor group (e.g., nonrhabdomyosarcoma soft tissue sarcomas, melanoma, or tumors in which the drug showed activity during the Phase 1
    portion of the study and/or in preclinical studies).
    Sezione di Fase 1: Determinare sicurezza e tollerabilità della dose massima tollerata pediatrica (MTD)/dose di Fase 2 raccomandata pediatrica (RP2D).
    Sezione di Fase 2: Caratterizzare l'attività antitumorale alla RP2D valutata mediante tasso di risposta globale (ORR).
    E.2.2Secondary objectives of the trial
    Phase I:
    - To evaluate pharmacokinetics (PK).
    - To characterize the ORR

    Phase II:
    - To characterize duration of response (DOR).
    - To characterize the disease control rate (DCR).
    - To characterize progression-free survival (PFS).
    - To characterize 1-year survival.
    - To confirm safety.
    - To evaluate PK.
    Sezione di Fase 1: Valutare la farmacocinetica (PK) e caratterizzare la ORR
    Sezione di Fase 2: Caratterizzare la durata della risposta (DOR), il tasso di controllo della malattia (DCR), la sopravvivenza libera da progressione (PFS), la sopravvivenza dopo 1 anno. Confermare la sicurezza e valutare la PK.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is male or female, meeting the following age requirements at the time the
    informed consent document (and assent form, if applicable) is signed.
    a. Phase 1: patient is ≥ 6 months to < 18 years of age
    b. Phase 2: patient is ≥ 6 months to ≤ 21 years of age

    2. Patient has a confirmed solid tumor diagnosis according to the following:
    a. Phase 1: patient has a recurrent or refractory solid tumor that has progressed or
    did not respond to standard therapy, or for which no standard anticancer therapy exists
    b. Phase 2: patient has one of the following tumor types and has failed first or
    second-line treatment or has evidence of refractory disease
    i. Group 1: neuroblastoma
    ii. Group 2: rhabdomyosarcoma
    iii. Group 3: mixed solid tumors, including nonrhabdomyosarcoma soft tissue
    sarcoma, melanoma, or other tumor types identified during the Phase 1 portion or in preclinical studies

    3. The patient has a Lansky/ Karnofsky performance status score of ≥ 70%

    4. The patient has adequate serum chemistry levels, evidenced by the following laboratory values
    a. AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN)
    b. Total bilirubin ≤ 1.5 × ULN
    c. Creatinine ≤ 1.5 × ULN

    5. The patient has adequate bone marrow function, evidenced by the following:
    a. Absolute neutrophil count ≥ 1.0 × 10^9 cells/L
    b. Platelets ≥ 80 × 10^9 cells/L (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
    c. Hemoglobin ≥ 8 g/dL (transfusion is permitted to fulfill this criterion)

    6. The patient (when applicable) or patient’s parent(s) or legal guardian(s) understand(s)
    and voluntarily signed an informed consent document prior to any study-related
    assessments/procedures being conducted. Where locally applicable, the patient also
    understands and voluntarily provides his/her assent prior to any study-related
    assessments/procedures being conducted.

    7. Male patients of childbearing potential must use a condom during sexual intercourse and shall not father a child during the study and for 6 months after the last dose of study medication.

    8. Female patients of childbearing potential [defined as all female patients ≥ 12 years old or who have reached menarche, whichever occurs first] must have both of the following:
    a. Agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study medication and for
    3 months following the last dose of study medication
    i. True abstinence: When this is in line with the preferred and usual lifestyle
    of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
    ii. Acceptable contraceptive methods include: oral, injectable, or implantable
    hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) including at least one barrier method.

    b. Have negative serum pregnancy test result at screening confirmed by negative
    urine pregnancy dipstick within 72 hours prior to first dose of IP (if serum test
    occurred > 72 hours from first dose); pregnancy test with sensitivity of at least 25
    mIU/mL
    1. Paziente di sesso maschile o femminile, che soddisfa i seguenti requisiti d'età al momento della firma del documento di consenso informato (e del modulo di assenso se pertinente).
    a. Fase 1: il paziente ha un'età compresa tra ≥ 6 mesi e < 18 anni
    b. Fase 2: il paziente ha un'età compresa tra ≥ 6 mesi e ≤ 21 anni
    2. Il paziente presenta una diagnosi confermata di tumore solido in conformità a quanto segue:
    a. Fase 1: il paziente presenta un tumore solido ricorrente o refrattario che è progredito o non ha risposto alla terapia standard, o per il quale non esiste una terapia antitumorale standard.
    b. Fase 2: il paziente presenta uno dei seguenti tipi di tumore, fallimento di trattamento di prima o seconda linea o evidenza di malattia refrattaria.
    i. Gruppo 1: neuroblastoma
    ii. Gruppo 2: rabdomiosarcoma
    iii. Gruppo 3: tumori solidi misti, incluso sarcoma dei tessuti molli non-rabdomiosarcoma, melanoma o altri tipi di tumore identificati durante la sezione di Fase 1 o nell'ambito di studi pre-clinici
    3. Il paziente presenta un punteggio dello stato di validità secondo Lansky/ Karnofsky ≥ 70%
    4. Il paziente presenta livelli di chimica del siero adeguati, dimostrati dai seguenti valori di laboratorio
    a. AST (SGOT) ALT (SGPT) ≤ 2,5 x limite superiore della norma (ULN)
    b. Bilirubina totale ≤ 1,5 X ULN
    c. Creatinina ≤ 1,5 × ULN
    5. Il paziente presenta funzionalità del midollo osseo adeguata, dimostrata da quanto segue:
    a. Conta assoluta dei neutrofili (ANC) ≥1,0 × 109 cellule/l
    b. Piastrine ≥ 80 × 109 cellule/l (indipendente da trasfusione, ossia che non ha ricevuto trasfusioni entro 7 giorni prima dell'analisi del campione in laboratorio)
    c. emoglobina ≥ 8 g/dl (la trasfusione è consentita per soddisfare questo criterio)
    6. Il paziente (laddove pertinente) o i(l) genitore/i o tutore/i legale/i del paziente comprende/comprendono e ha/hanno volontariamente firmato un documento di consenso informato prima che fosse condotta qualsiasi valutazione/procedura correlata allo studio. Laddove localmente applicabile, il paziente inoltre comprende e fornisce volontariamente il suo assenso prima che sia condotta qualsiasi valutazione/procedura correlata allo studio.
    7. I pazienti di sesso maschile in età fertile devono usare un preservativo durante il rapporto sessuale e non dovranno concepire un figlio durante lo studio e per 6 mesi dopo la somministrazione dell'ultima dose di farmaco in studio.
    8. Le pazienti di sesso femminile in età fertile [definite come tutte le pazienti di sesso femminile di età ≥ 12 o che abbiano raggiunto il menarca qualunque di questi eventi si verifichi per primo] dovranno presentare entrambi i seguenti requisiti:
    a. Accettare l'uso simultaneo di due metodi contraccettivi approvati dal medico o praticare l'astinenza completa durante l'assunzione del farmaco in studio e per 3 mesi dopo l'assunzione dell'ultima dose di farmaco in studio.
    i. Astinenza totale: Se questo fosse in linea con lo stile di vita consueto e preferibile dal paziente. L'astinenza periodica (come i metodi del calendario, dell’ovulazione, sintotermica, postovulazione) e il coito interrotto non sono metodi contraccettivi accettabili.
    ii. I metodi contraccettivi accettabili comprendono: contraccettivo ormonale orale, iniettabile, o impiantabile; legatura delle tube; dispositivo intrauterino; contraccettivo di barriera con spermicida; o partner vasectomizzato) incluso almeno un metodo di barriera.
    b. Presentare un test di gravidanza sul siero con risultato negativo allo screening confermato da test di gravidanza sulle urine con dipstick negativo entro 72 ore prima della somministrazione della prima dose di IP (se il test sul siero è stato eseguito > 72 ore dalla somministrazione della prima dose); test di gravidanza con una sensibilità di almeno 25 mIU/ml
    E.4Principal exclusion criteria
    1. The patient has a primary brain tumor(s) or brain metastasis (unless metastasis is treated and stable for > 28 days). In patients who are symptomatic, a brain scan is required to exclude metastasis.

    2. The patient has received therapeutic dose chemotherapy or radiotherapy ≤ 21 days prior to start of IP.

    3. The patient has received maintenance dose chemotherapy (e.g., low dose
    cyclophosphamide) ≤ 7 days from the first dose of IP.

    4. The patient has received any investigational therapy ≤ 28 days prior to start of IP.
    Investigational therapy is defined as any medicinal product that is not approved in the
    country of treatment for any indication, adult or pediatric

    5. The patient has received any biological therapy ≤ 7 days prior to the start of IP, or
    monoclonal antibody ≤ 3 half-lives or 28 days, whichever is shorter, prior to the first dose of IP.

    6. The patient has had major surgery or significant trauma ≤ 14 days prior to start of IP.

    7. The patient has not recovered from the acute toxic effects of prior chemotherapy,
    radiation, or major surgery/significant trauma.

    8. The patient has had minor surgery ≤ 7 days from the start of study treatment (excluding the placement of central/
    peripheral lines, skin biopsy).

    9. The patient has a known history of stroke, myocardial infarction, peripheral vascular disease, or recent (within 3 months) uncontrolled deep venous thrombosis.

    10. The patient has a known history or current diagnosis of HIV infection, regardless of treatment status.

    11. The patient has an uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy, symptomatic heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

    12. The patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.

    13. The patient has any condition, including the presence of laboratory abnormalities, that places him/her at unacceptable risk if he/she were to participate in the study.

    14. The patient has any condition that confounds the ability to interpret data from the study.

    15. The patient or parent(s)/guardian(s) is/are unable to comply with the study visit schedule and other protocol requirements, in the opinion of the investigator.
    1. Il paziente presenta tumore/i cerebrale/i primario/i o metastasi cerebrale (salvo il caso in cui la metastasi sia trattata e stabile per > 28 giorni). Per i pazienti sintomatici è necessario eseguire una scansione cerebrale per escludere la metastasi.
    2. Il paziente ha ricevuto una dose terapeutica di chemioterapia o radioterapia ≤ 21 giorni prima dell'inizio della somministrazione di IP.
    3. Il paziente ha ricevuto una dose di mantenimento di chemioterapia (per esempio ciclofosfamide a basso dosaggio) ≤ 7 giorni dall'assunzione della prima dose di IP.
    4. Il paziente ha ricevuto qualsiasi terapia sperimentale ≤ 28 giorni prima dell'inizio della somministrazione di IP. La terapia sperimentale si definisce come qualsiasi prodotto farmacologico che non sia stato approvato nel paese in cui il trattamento deve essere eseguito per qualsiasi indicazione, per pazienti adulti o pediatrici.
    5. il paziente ha ricevuto qualsiasi terapia biologica ≤ 7 giorni prima dell'inizio del trattamento con IP, o anticorpo monoclonale per ≤ 3 emivite o 28 giorni, qualunque di questi periodi sia più breve, prima della somministrazione della prima dose di IP.
    6. Il paziente è stato sottoposto a intervento chirurgico maggiore o ha subito un trauma rilevante ≤ 14 giorni prima dell'inizio della somministrazione di IP.
    7. Il paziente non si è ripreso dagli effetti tossici acuti di una precedente chemioterapia, terapia con radiazioni, o intervento chirurgico maggiore/trauma rilevante.
    8. Il paziente è stato sottoposto a intervento chirurgico minore ≤ 7 giorni dall'inizio del trattamento in studio (escluso il posizionamento di cateteri centrali/periferici, biopsia cutanea).
    9. Il paziente ha una nota anamnesi di ictus, infarto miocardico, malattia vascolare periferica o trombosi venosa profonda non-controllata recente (entro 3 mesi).
    10. Il paziente ha una nota anamnesi di o presenta una diagnosi attuale di infezione da HIV, indipendentemente dallo stato del trattamento.
    11. Il paziente presenta una malattia intercorrente non-controllata, inclusa ma non è limitata a infezione in corso o attiva che richieda terapia con antibiotici, antifungini o antivirali insufficienza cardiaca sintomatica, aritmia cardiaca, o malattia psichiatrica/situazioni sociali che limiterebbero l'aderenza ai requisiti dello studio.
    12. Il paziente presenta qualsiasi condizione clinica rilevante, anomalia di laboratorio o malattia psichiatrica che impedirebbe al paziente di partecipare allo studio.
    13. Il paziente presenta qualsiasi condizione, compresa la presenza di anomalie di laboratorio, che esporrebbe il paziente a un rischio inaccettabile nel caso in cui partecipasse allo studio.
    14. Il paziente presenta qualsiasi condizione in grado di alterare la capacità di interpretare i dati provenienti dallo studio.
    15. Il paziente o il/i genitore/i tutore/i non è/sono in grado di aderire al programma di visite dello studio e ad altri requisiti del protocollo, a giudizio dello sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I:
    Incidence of DLTs and the incidence of treatment-emergent adverse events (TEAEs).

    Phase II:
    - ORR (CR + PR) confirmed no less than 4 weeks after the criteria for response are first
    met, based on RECIST version 1.1 criteria
    Fase I: Incidenza di DLTs ed incidenza di eventi avversi emergenti dal trattamento (TEAEs)
    Fase II: tasso di risposta globale (ORR) (completa risposta (CR) + parziale risposta (PR)) confermata a non meno di 4 settimane dopo che i criteri di risposta (RECIST 1.1) siano stati soddisfatti
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I:
    Initial 1-2 cycles of treatment

    Phase II:
    Expected 12-16 weeks after starting treatment; longer depending on the patient
    Fase I: iniziali cicli di trattamento (1-2)
    Fase II: 12-16 settimane dopo l’inizio del trattamento; più a lungo a seconda del paziente.
    E.5.2Secondary end point(s)
    Phase I:
    1) PK parameters including the maximum observed concentration in blood
    (Cmax), area under the blood concentration-time curve (AUC), clearance and volume of distribution (Vss).
    2) ORR

    Phase II:
    1) DoR in patients with a confirmed objective CR or partial response (PR)
    DCR is the percentage of patients with a confirmed objective CR or PR, or stable disease for at least 16 weeks.
    2) PFS based on investigator assessment of response using RECIST 1.1 guidelines
    3) Survival at 1 year
    4) The incidence of TEAEs
    5) Population PK parameters
    Fase I: 1) parametri farmacocinetici inclusa, la massima concentrazione osservata nel sangue (Cmax), l’area sotto la curva (AUC), la clearance ed il volume di distribuzione (Vss); 2) ORR.
    Fase II: 1) durata della risposta (DOR) in pazienti con CR o PR confermata; 2) grado di controllo della malattia (DCR) come percentuale dei pazienti con CR o PR confermata per almeno 16 settimane; 3) sopravvivenza libera da progressione (PFS) secondo le linee guida RECIST 1.1; 4) sopravvivenza a 1 anno; 5) incidenza di TEAEs; 6) parametri farmacocinetici della popolazione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase I:
    1) and 2) Up to 4 days after the first treatment.

    Phase II:
    1)Until progression according to RECIST 1.
    Expected 24 weeks after treatment starts; longer depending on the patient.
    2)Until PFS event
    3)1 Year after starting treatment
    4)Up to 28 days after stopping study treatment
    5)Up to 4 days after the first treatment.
    Fase I: fino a 4 giorni dopo il primo trattamento
    Fase II: 1) sino a progressione secondo RECIST 1.1; 2) 24 settimane dopo l’inizio del trattamento; più a lungo a seconda del paziente; 3) sino all’evento PFS; 4) a 1 anno dopo il trattamento; 5) fino a 28 giorni dopo il termine del trattamento; 6) fino a 4 giorni dopo il primo 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) 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
    Phase I / II
    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 Information not present in EudraCT
    E.8.1.2Open Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Fase I: incremento graduale della dose di tipo rolling-6. Fase II: trattamento con MTD/RP2D
    phI: rolling-6 dose escalation; phII: treatment with MTD/RP2D
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Switzerland
    United States
    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
    After the EOT visit, all patients will be followed for survival until death, lost to follow-up, or one year after EOT, whichever occurs first.
    The study will end when all patients have completed the posttreatment follow-up (max 1 year) or have died, whichever occurs first
    Dopo la visita di fine studio, tutti i pazienti saranno seguiti per informazioni relative alla sopravvivenza sino alla morte, scomparsa al follow up o sino a 1 anno dalla visita di fine studio. Lo studio terminerà quando tutti i pazienti avranno completato il follow up o sono morti.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 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 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 11
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 45
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 44
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors (< 18 years old)
    Minori (età inferiore a 18 anni)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 81
    F.4.2.2In the whole clinical trial 106
    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)
    Patients may remain on treatment until disease progression, unacceptable toxicity, until they begin a new anticancer therapy, withdrawal of consent, parent/guardian/patient refusal, physician decision or death
    Upon treatment discontinuation from any of these reasons, patients will be treated at the investigator decision
    I pazienti potranno rimanere in trattamento sino a progressione della malattia, tossicità inaccettabile, inizio di un nuovo trattamento antitumorale, rifiuto o ritiro del consenso da parte dei genitori/tutore/paziente, decisione del medico, o decesso. Dopo l’interruzione del trattamento per qualsiasi ragione, i pazienti saranno trattati secondo il giudizio del medico.
    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 Decision2013-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
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