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    Summary
    EudraCT Number:2014-004281-25
    Sponsor's Protocol Code Number:MLN1117-1501
    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:2016-10-10
    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 number2014-004281-25
    A.3Full title of the trial
    A Phase 1b/Adaptive Phase 2 Study of Docetaxel With or Without MLN1117
    in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
    Studio adattativo di Fase Ib/II sull’utilizzo di docetaxel in combinazione o meno a MLN1117 in pazienti con tumore al polmone non a piccole cellule localmente avanzato o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1b/Adaptive Phase 2 Study of Docetaxel With or Without MLN1117
    in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
    Studio adattativo di Fase Ib/II sull’utilizzo di docetaxel in combinazione o meno a MLN1117 in pazienti con tumore al polmone non a piccole cellule localmente avanzato o metastatico
    A.3.2Name or abbreviated title of the trial where available
    A Phase 1b/Adaptive Phase 2 Study of Docetaxel With or Without MLN1117 in Patients With Locally Adva
    Studio adattativo di Fase Ib/II sull’utilizzo di docetaxel in combinazione o meno a MLN1117 in pazie
    A.4.1Sponsor's protocol code numberMLN1117-1501
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02393209
    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 SponsorMILLENNIUM PHARMACEUTICALS, INC.
    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 supportMillennium Pharmaceuticals, Inc. - Stati Uniti d'America
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointHess Suh
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number1 617 444 4341
    B.5.5Fax number1 617 444 4341
    B.5.6E-mailHaeSuk.Suh@takeda.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 nameMLN1117
    D.3.2Product code MLN1117
    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 INNMLN1117
    D.3.9.2Current sponsor codeMLN1117
    D.3.9.3Other descriptive nameMLN1117
    D.3.9.4EV Substance CodeSUB126088
    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 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 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 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 nameMLN1117
    D.3.2Product code MLN1117
    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 INNMLN1117
    D.3.9.2Current sponsor codeMLN1117
    D.3.9.3Other descriptive nameMLN1117
    D.3.9.4EV Substance CodeSUB126088
    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 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 No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 DOCETAXEL ACTAVIS - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO MONODOSE DA 1 ML
    D.2.1.1.2Name of the Marketing Authorisation holderACTAVIS GROUP PTC EHF
    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 namedocetaxel
    D.3.2Product code docetaxel
    D.3.4Pharmaceutical form 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 INNDOCETAXEL
    D.3.9.1CAS number 1268454-23-4
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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
    non-small cell lung cancer (NSCLC)
    tumore al polmone non a piccole cellule (NSCLC)
    E.1.1.1Medical condition in easily understood language
    non-small cell lung cancer (NSCLC)
    tumore al polmone non a piccole cellule (NSCLC)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 2: To evaluate progression-free survival (PFS) as the primary efficacy measure of MLN1117 plus docetaxel versus docetaxel alone in patients with advanced NSCLC
    Fase 2: Valutare la sopravvivenza libera da progressione (PFS) come misura di efficacia primaria di MLN1117 più docetaxel rispetto a docetaxel da solo in pazienti con NSCLC avanzato
    E.2.2Secondary objectives of the trial
    PHASE 2:
    - To evaluate the safety and tolerability of MLN1117 plus docetaxel administered to patients with NSCLC
    - To evaluate the PK of MLN1117 when dministered with docetaxel
    - To evaluate additional efficacy measures, such as response rate (RR), disease control rate, response duration, time to progression (TTP), and OS, of MLN1117 plus docetaxel versus docetaxel alone in patients with NSCLC
    - To evaluate PFS and additional efficacy measures of MLN1117 plus docetaxel versus docetaxel alone in different populations of patients with NSCLC, such as patients with squamous NSCLC versus
    nonsquamous NSCLC, and patients with squamous NSCLC with or without PIK3CA mutation and/or amplification (MUT/AMP)
    FASE 2:
    - valutare la sicurezza e la tollerabilità di MLN1117 più docetaxel
    somministrato a pazienti con NSCLC
    - Valutare la PK di MLN1117 quando somministrato con docetaxel
    - Valutare le misure di efficacia aggiuntive, come il tasso di risposta (RR),
    tasso di controllo della malattia, la durata della risposta, il tempo alla progressione (TTP), e
    OS, di MLN1117 più docetaxel rispetto al solo docetaxel in pazienti con
    NSCLC
    - Valutare PFS e misure di efficacia addizionali di MLN1117 più docetaxel rispetto al solo docetaxel in diverse popolazioni di pazienti con NSCLC, come i pazienti con NSCLC squamoso contro NSCLC non squamoso, e pazienti con NSCLC squamoso con o senza mutazioni e/o amplificazione (MUT / AMP) di PIK3CA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Has a histologically and/or cytologically confirmed diagnosis of NSCLC (squamous or nonsquamous).
    •For Phase 2, has a diagnosis of mixed squamous and nonsquamous (or adenosquamous) NSLC.
    •Has locally advanced or metastatic disease (Stage IIIb or Stage IV) with radiographically or clinically evaluable lesions.
    •Has experienced failure of at least 1 prior chemotherapy regimen.
    •For Phase 2, has received 1 prior platinum-based chemotherapy regimen (excluding a docetaxel containing regimen) for advanced or metastatic (Stage IIIb or Stage IV) disease followed by documented progressive disease.
    •For Phase 2, has archived or fresh tumor biopsy samples obtained during screening sufficient for genotyping.
    •Has adequate organ function, before the first dose of study drug.
    •Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
    •Female participants who are postmenopausal for at least 1 year before the screening visit or are surgically sterile, or are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to practice true
    abstinence.
    •Male participants agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or agree to practice true abstinence.
    •Has suitable venous access for the study-required blood sampling.
    •Has recovered (ie, <= Grade 1 toxicity or eligibility per this protocol is met) from the reversible effects of prior anticancer therapy.
    • diagnosi istologicamente e/o citologicamente confermata di NSCLC (squamoso o non squamoso).
    • Per la fase 2, diagnosi di NSLC misto squamoso e non squamoso (o adenosquamoso).
    • malattia metastatica o localmente avanzata (stadio IIIb o stadio IV) con lesioni radiologicamente o clinicamente valutabili.
    • fallimento di almeno 1 precedente regime chemioterapico.
    • Per la fase 2, ha ricevuto 1 precedente regime chemioterapico a base di platino (esclusione di un regime contenente docetaxel) per malattia avanzata o metastatica seguita da documentata progressione della malattia (stadio IIIb o stadio IV).
    • Per la fase 2, sono presenti campioni bioptici tumorali freschi o archiviati ottenuti durante lo screening sufficienti per la genotipizzazione.
    • adeguata funzionalità dell’organo, prima della prima dose del farmaco in studio.
    • ECOG Performance Status di 0 o 1.
    • partecipanti donne in menopausa da almeno 1 anno prima della visita di screening o che sono chirurgicamente sterili, o che sono in età fertile e accettano di utilizzare 2 metodi contraccettivi efficaci, allo stesso tempo, dal momento della firma del consenso informato fino a 30 giorni dopo l'ultima dose del farmaco in studio, o accettare di praticare vera astinenza.
    • i partecipanti maschi si impegnano ad utilizzare efficaci metodi contraccettivi a barriera durante l'intero periodo di trattamento dello studio e fino a 120 giorni dopo l'ultima dose di farmaco in studio, o ad accettare di praticare l'astinenza vero.
    • accesso venoso adatto per il campionamento di sangue richiesto dallo studio.
    • recupero (cioè, <= 1 grado di tossicità o di ammissibilità per questo protocollo è soddisfatto) dagli effetti reversibili della terapia antitumorale precedente.
    E.4Principal exclusion criteria
    •Previous treatment with a PI3K or AKT inhibitor.
    •Prior cancer therapy or other investigational therapy within 2 weeks before the first administration of study drug or failed to recover from the reversible effects of prior anticancer therapies. For prior therapies with a half-life longer than 3 days, the interval must be at least 28 days before
    the first administration of study drug, and the patient must have documented progressive disease.
    •Has poorly controlled diabetes mellitus defined as HbA1c > 6.5%.
    •Has taken strong inhibitors or strong inducers of CYP3A4 within 14 days before the first dose of study drug.
    •Has taken histamine-H2 receptor antagonists and/or neutralizing antacids within 24 hours before the first administration of study drug.
    •Has taken proton pump inhibitors within 7 days before the first administration of study drug.
    •Has any clinically significant co-morbidities.
    •Has acute myocardial infarction within 6 months before starting study drug, current or history of New York Heart Association Class III or IV heart failure, Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or ECG evidence of acute ischemia or active conduction system abnormalities,
    Fridericia's corrected QT interval > 475 milliseconds (msec) (males) or > 450 msec (females) on a 12-lead ECG during the Screening period, or abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that in the opinion of the investigator are considered to be clinically significant.
    •Has known, previously diagnosed human immunodeficiency virus infection or active chronic hepatitis B or C.
    •Has brain metastasis, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids, and do not have neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
    •Has active secondary malignancy that requires treatment.
    •Has any serious medical or psychiatric illness, including drug or alcohol abuse.
    •Male participants who intend to donate sperm during the course of this study or 120 days after receiving their last dose of study drug.
    •Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive
    urine pregnancy test on Day 1 before administration of the first dose of study drug
    • precedente trattamento con un inibitore della PI3K o AKT.
    • precedente terapia anticancro o altre terapie sperimentali entro 2 settimane prima della prima somministrazione del farmaco in studio o mancata ripresa dagli effetti reversibili di terapie antitumorali precedenti. Per terapie precedenti con una emivita più di 3 giorni, l'intervallo deve essere di almeno 28 giorni prima della prima somministrazione del farmaco in studio, e il paziente deve presentare documentata malattia progressiva.
    • diabete mellito mal controllato definito come HbA1c> 6,5%.
    • somministrazione di potenti inibitori o potenti induttori del CYP3A4 entro 14 giorni prima della prima dose del farmaco in studio.
    • somministrazione di antagonisti dei recettori dell'istamina H2 e/o antiacidi neutralizzanti entro 24 ore prima della prima somministrazione del farmaco in studio.
    • somministrazione di inibitori della pompa protonica entro 7 giorni prima della prima somministrazione del farmaco in studio.
    • eventuali clinicamente significative comorbidità.
    • infarto miocardico acuto entro 6 mesi prima di iniziare il farmaco in studio, in corso o storia di insufficienza cardiaca di classe III o IV secondo New York Heart Association, Evidenza di malattie cardiovascolari non controllate in corso compresi aritmie cardiache, angina, ipertensione polmonare, o evidenza all’ECG di ischemia acuta o anomalie attive del sistema di conduzione, intervallo QT corretto di Fridericia> 475 millisecondi (msec) (maschi) o> 450 msec (femmine) su un ECG a 12 derivazioni durante il periodo di screening, o anomalie di ECG a 12 derivazioni, tra cui, ma non limitati a, variazioni di ritmo e intervalli che a giudizio dello sperimentatore sono considerati clinicamente significativi.
    • conosciuta e in precedenza diagnosticata infezione da virus dell'immunodeficienza umana o epatite cronica B o C attiva.
    • metastasi cerebrali, fatta eccezione per quei pazienti che hanno completato la terapia definitiva, non sono sotto steroidi, hanno uno stato neurologico stabile per almeno 2 settimane dopo il completamento della terapia definitiva e steroidi, e non hanno una disfunzione neurologica che confonda la valutazione neurologica e di altri eventi avversi.
    • tumore maligno secondario attivo che richiede un trattamento.
    • malattia medica o psichiatrica grave, tra cui droga o alcol.
    • partecipanti maschi che intendono donare sperma durante il corso di questo studio o 120 giorni dopo la ricezione loro ultima dose del farmaco in studio.
    • partecipanti donne che stanno allattando e che presentino test di gravidanza sul siero positivo durante il periodo di screening o test di gravidanza sulle urine positivo al giorno 1 prima della somministrazione della prima dose del farmaco in studio
    E.5 End points
    E.5.1Primary end point(s)
    Progress-Free Survival
    Sopravvivenza libera da progressione
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLTs, MTD, and RP2D may occur at any time. PFS data will be collected during the posttreatment follow-up period of up to 6 months after the last dose of study drug
    DLT, MTD, e RP2D può verificarsi in qualsiasi momento. Dati PFS saranno raccolti durante il periodo di follow-up post-trattamento fino a 6 mesi dopo l'ultima dose del farmaco in studio
    E.5.2Secondary end point(s)
    Endpoints for phase 2 - Safety: o Vital signs o Physical examination findings o 12-lead ECG o Clinical laboratory test results o AEs and SAEs - Response rate (complete response [CR] + partial response [PR]), disease control rate (CR + PR + stable disease [SD]), duration of response (DOR), and TTP - Overall Survival - MLN1117 plasma concentrations when administered 1 day after docetaxel - Exploratory endpoints o Correlation between PIK3CA and/or other mutations detected in circulating tumor DNA and tumor tissue DNA o Correlation between the amount of and allelic frequencies of PIK3CA and/or othermutations detected in circulating tumor DNA and clinical response o Genetic polymorphisms in genes encoding drug metabolizing enzymes and/or transporters on the PK of MLN1117 and/or in genes related to clinical response and/or study drug-related toxicity o HRQOL, physical functioning, and other effects of the disease and/or therapy as measured by the PRO instruments the EORTC QLQ-C30(1, 2) and the EORTC QLQLC-13(3)
    Endpoint per la fase 2 - Sicurezza: o segni vitali o risultati dell'esame fisico o ECG a 12 derivazioni o risultati dei test di laboratorio clinico o eventi avversi e avversi gravi - Tasso di risposta (risposta completa [CR] + risposta parziale [PR]), tasso di controllo della malattia (CR + PR + malattia stabile [SD]), durata della risposta (DOR), e TTP - sopravvivenza complessiva - concentrazioni plasmatiche di MLN1117 quando somministrato 1 giorno dopo docetaxel - Endpoint esplorativi o Correlazione tra PIK3CA e/o altre mutazioni rilevate nel DNA tumorale circolante e DNA tumorale del tessuto o correlazione tra la quantità di frequenze alleliche e di PIK3CA e/o altre mutazioni del DNA tumorale circolante rilevate e la risposta clinica o polimorfismi genetici in geni che codificano per enzimi metabolizzanti i farmaci e/o trasportatori sulla PK di MLN1117 e/o in geni legati alla risposta clinica e/o alla tossicità correlata al farmaco di studio o HRQOL, funzionalità fisica, e altri effetti della malattia e/o della terapia come misurato dagli strumenti PRO EORTC QLQ-C30 (1, 2) e EORTC QLQLC-13 (3)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Any time during phase II of the study
    In qualsiasi momento durante la fase II dello studio
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Genetic testing
    Test genetici
    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
    expans combined treat dose
    espansione dose trattamento combinato
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA 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
    Italy
    Netherlands
    Norway
    Spain
    United Kingdom
    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 study will be terminated 6 months after the last patient completes an EOT study visit
    Lo studio sarà conclusa 6 mesi dopo che l'ultimo paziente compie la visita di fine studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 99
    F.4.2.2In the whole clinical trial 155
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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