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    Summary
    EudraCT Number:2014-005018-47
    Sponsor's Protocol Code Number:008-IRCC-10IIS-14
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-005018-47
    A.3Full title of the trial
    A PHASE II, RANDOMIZED, MULTICENTER STUDY TO ASSESS THE EFFICACY OF NAB-PACLITAXEL-BASED DOUBLET AS FIRST LINE THERAPY IN PATIENTS WITH CANCER OF UNKNOWN PRIMARY (CUP): the AGNOSTOS trial
    A phase II, randomized, multicenter study to assess the efficacy of nab-paclitaxel-based doublet as first line therapy in patients with cancer of unknown primary (CUP): The AGNOSTOS trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the treatment of Cancer of Unknown Primary (CUP) with nab-Paclitaxel in association with gemcitabine or carboplatin
    Studio di fase II, randomizzato, multicentrico per valutare l’efficacia di due diverse combinazioni a base di nab-Paclitaxel per una terapia di prima linea in pazienti con Tumore a Primitività Sconosciuta (CUP): protocollo AGNOSTOS
    A.3.2Name or abbreviated title of the trial where available
    AGNOSTOS
    AGNOSTOS
    A.4.1Sponsor's protocol code number008-IRCC-10IIS-14
    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 DEL PIEMONTE PER L'ONCOLOGIA IRCCS
    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 supportCELGENE International II Sàrl
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportAIRC
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione del Piemonte per l'Oncologia
    B.5.2Functional name of contact pointCLINICAL TRIALS COORDINATION UNIT
    B.5.3 Address:
    B.5.3.1Street AddressSTRADA PROVINCIALE 142 KM 3.95
    B.5.3.2Town/ cityCANDIOLO (TO)
    B.5.3.3Post code10060
    B.5.3.4CountryItaly
    B.5.4Telephone number0119933926
    B.5.5Fax number0119621525
    B.5.6E-mailsilvia.marsoni@ircc.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 ABRAXANE - 5 MG/ML - POLVERE PER SOSPENSIONE PER INFUSIONE - USO ENDOVENOSO- 100 MG - FLACONCINO(VETRO) 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE B.V. (NETHERLANDS)
    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 nameAbraxane
    D.3.2Product code [Abraxane]
    D.3.4Pharmaceutical form Powder for solution 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 ALBUMINA
    D.3.9.1CAS number 33069-62-4
    D.3.9.2Current sponsor codeAbraxane
    D.3.9.3Other descriptive namenab-paclitaxel
    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 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 GEMCITABINA HOSPIRA ITALIA - 38 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 2 G/52.6 ML
    D.2.1.1.2Name of the Marketing Authorisation holderHOSPIRA ITALIA S.R.L.
    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 nameGemcitabina
    D.3.2Product code [Gemcitabina]
    D.3.4Pharmaceutical form 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 INNGEMCITABINA
    D.3.9.1CAS number 95058-81-4
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive namegemcitabine
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CARBOPLATINO TEVA - 1 FLACONE IV 45 ML 10 MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA PHARMA B.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 nameCarboplatino
    D.3.2Product code [SUB06614MIG]
    D.3.4Pharmaceutical form 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 INNCARBOPLATINO
    D.3.9.1CAS number 41575-94-4
    D.3.9.2Current sponsor codeCARBOPLATINO
    D.3.9.3Other descriptive namecarboplatin
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Cancers of Unknown Primary (CUP)
    Tumori a primitività sconosciuta (CUP)
    E.1.1.1Medical condition in easily understood language
    Metastatic cancer without tumor of origin identified
    Tumore con metastasi senza massa tumorale di origine individuata
    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 PT
    E.1.2Classification code 10073059
    E.1.2Term Malignant neoplasm of unknown primary site
    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
    To assess the efficacy (as measured by objective tumor response) of nab-paclitaxel in combination with either carboplatin or gemcitabine in treatment-naïve patients with CUP.
    Valutare l’efficacia, misura obiettiva della risposta tumorale (RECIST), del nab-Paclitaxel in combinazione con il carboplatino o la gemcitabine in pazienti CUP non precedentemente trattati.
    E.2.2Secondary objectives of the trial
    - To assess the duration of response, time to progression (TTP) and overall survival (OS) of CUP patients after nab-paclitaxel- gemcitabine or nab-paclitaxel- carboplatin;
    - to evaluate the safety of combining nab-paclitaxel with gemcitabine or carboplatin in CUP patients treatment.
    - Valutare la durata della risposta, il tempo alla progressione (TTP) e la sopravvivenza (OS) dopo trattamento con gemcitabina o carboplatino più nab-Paclitaxel;
    - valutare la sicurezza della combinazione di gemcitabina e nab-paclitaxel o carboplatino e nab-paclitaxel nel trattamento dei pazienti CUP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Provision of written informed consent.
    - Patients must be = 18 years of age.
    - Diagnosis of CUP according to CUP Diagnostic Guidelines derived from ESMO 2011 and NCCN 2015 guidelines.
    - Sufficient archived biopsy tissue from a surgical or core needle biopsy required to perform the CUP multiplex assay.
    - Eastern Cooperative Oncology Group performance status = 2.
    - No previous systemic therapy.
    - At least one measurable lesion by RECIST Criteria.
    - Good liver, cardiac, lung and marrow bone function.
    - Evidence of non-childbearing status for female patients: negative urine or serum pregnancy test within 21 days of study treatment for women of childbearing potential, or postmenopausal status.
    - Patients of child bearing potential and their partners, who are sexually active, must agree to the use of highly effective forms of contraception throughout their participation in the study.
    - Patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.
    - Consenso Informato firmato.
    - Pazienti con età = 18 anni.
    - Diagnosi di CUP secondo le CUP Diagnostic Guidelines derivanti dalle linee guida ESMO 2011 e NCCN 2015..
    - Disponibilità sufficiente di tessuto di archivio proveniente da una biopsia chirurgica o da ago-biopsia per eseguire il test multiplex.
    - ECOG = 2.
    - Nessuna precedente terapia sistemica.
    - Almeno una lesione misurabile secondo i criteri RECIST.
    - Buona funzionalità epatica, cardiaca, polmonare e del midollo osseo.
    - Test di gravidanza negativo per le pazienti di sesso femminile in età fertile.
    - Le pazienti in età fertile e i loro partner, sessualmente attivi, devono usare efficaci metodi di contraccezione durante la loro partecipazione allo studio.
    - Il paziente deve rispettare il protocollo per la durata dello studio, compresi il trattamento farmacologico, le visite programmate e gli esami.
    E.4Principal exclusion criteria
    - Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, breast Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma.
    - Specific treatable CUP syndromes including: extragonadal germ cell syndrome; neuroendocrine carcinoma; adenocarcinoma isolated to axillary lymph nodes (women cancer); peritoneal carcinomatosis (women - ovarian cancer); squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes; single resectable metastasis.
    - Patients receiving any radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry.
    - Patients with symptomatic uncontrolled brain metastases.
    - Major surgery within 2 weeks of starting the study and patients must have recovered from any effects of any major surgery.
    - Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
    - Pregnant or breast feeding women.
    - Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).
    - Patients with known hepatic disease (eg, Hepatitis B or C).
    - Previous cancer treatment.
    - Patients currently enrolled in another clinical trial, except AGNOSTOS PROFILING.
    - Patients that are receiving chemotherapy, hormonal therapy (HRT is acceptable) or other novel agents.
    - Patients receiving live virus and bacterial vaccines.
    - Pazienti con un secondo tumore primario, eccetto: tumore della pelle non melanocitico adeguatamente trattato, carcinoma in situ della cervice con outcome terapeutico positivo, carcinoma duttale della mammella in situ (DCIS), carcinoma dell’endometrio di stadio 1 e grado 1.
    - Pazienti con specifici tumori a primitività sconosciuta trattabili, incluso: sindrome delle cellule germinali extragonadali; carcinoma neuroendocrino; adenocarcinoma isolato ai linfonodi ascellari (tumori delle donne); carcinomatosi peritoneale (donne - tumore ovarico); carcinoma squamoso limitato ai linfonodi cervicali, sopraclavicolari o inguinali; singole metastasi resecabili.
    - Pazienti trattati con radioterapia (eccetto a scopo palliativo) nelle due settimane precedenti la prima somministrazione di farmaco sperimentale.
    - Pazienti con metastasi cerebrali sintomatiche e non controllate.
    - Pazienti sottoposti a trattamento chirurgico maggiore nelle due settimane precedenti l’inizio dello studio e pazienti ospedalizzati in seguito a qualsiasi effetto derivante da qualsiasi trattamento chirurgico maggiore.
    - Pazienti considerati a basso rischio medico a causa di disturbi medici seri e non controllati, malattie sistemiche di natura non maligna, infezioni attive e non controllate. Alcuni esempi sono aritmia ventricolare non controllata, infarto del miocardio (nei 6 mesi precedenti), disturbi convulsivi maggiori non controllati, compressione instabile del midollo spinale, sindrome della vena cava superiore, qualsiasi disturbo psichiatrico che impedisca di ottenere il consenso informato.
    - Donne in gravidanza o in periodo di allattamento.
    - Pazienti immunocompromessi, ad esempio pazienti consapevoli di essere sierologicamente positivi per il virus dell’immunodeficienza umana (HIV).
    - Pazienti con malattie epatiche note (es. Epatite B o C).
    - Pazienti precedentemente trattati con terapie antitumorali.
    - Pazienti contemporaneamente arruolati in altri studi clinici, eccetto AGNOSTOS PROFILING.
    - Pazienti in trattamento con chemioterapia, terapia ormonale (escluso terapia ormonale sostitutiva) o altri agenti antitumorali.
    - Pazienti in trattamento con vaccini batterici o virali.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) as evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines
    - Tasso di risposta (ORR) valutato in base ai criteri di valutazione della risposta nei tumori solidi (RECIST) linee guida versione 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every nine weeks with >/ = confirmation of response every 4 weeks.
    Ogni 9 settimane con >/= conferma della risposta ogni 4 settimane.
    E.5.2Secondary end point(s)
    - Efficacy: TTP, OS, and duration of response according to RECIST version 1.1; - Safety: toxicity according to CTCAE version 4.03
    - Efficacia: TTP, OS e durata della risposta secondo I criteri RECIST versione 1.1; - Tossicità secondo le CTCAE versione 4.03 (sicurezza).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every nine weeks with >/ = confirmation of response every 4 weeks; As required by law in the field of pharmacovigilace in clinical trials
    Ogni 9 settimane con >/= conferma della risposta ogni 4 settimane.; Secondo quanto previsto dalla normativa vigente in ambito di farmacovigilaza nelle sperimentazioni cliniche
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    L'obiettivo di questo disegno è individuare quale regime sperimentale dovrebbe essere il miglior can
    The goal of this design is prioritizing which (if any) experimental regimen should move to next deve
    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 concerned12
    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 years3
    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 years3
    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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state132
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 132
    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)
    Follow-up visit for patients without documented PD at the time of treatment withdrawal: to be performed every 8 weeks until PD or another anti-cancer therapy is initiated, whichever comes first. Evaluations to be performed according to clinical practice.
    Visite di follow up ogni 8 settimane per pazienti non ancora in progressione di malattia al termine della loro partecipazione allo studio, fino ad inizio di un nuovo trattamento antitumorale oppure in seguito a progressione di malattia.
    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 Decision2015-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-17
    P. End of Trial
    P.End of Trial StatusOngoing
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