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    EudraCT Number:2012-003590-25
    Sponsor's Protocol Code Number:HER-URO01
    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:2012-11-06
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-003590-25
    A.3Full title of the trial
    Phase II study of the Pan-HER inhibitor Dacomitinib (PF-00299804) for patients with locally advanced or metastatic squamous cell carcinoma of the penis
    Phase II study of the Pan-HER inhibitor Dacomitinib (PF-00299804) for patients with locally advanced or metastatic squamous cell carcinoma of the penis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with a Pan-HER inhibitor in locally advanced/metastatic squamous cell carcinoma of the penis.
    Trattamento con inibitore Pan-HER nelle neoplasie spinocellulari del pene localmente avanzate/metastatiche.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberHER-URO01
    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.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 supportFondazione IRCCS Istituto Nazionale dei Tumori
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale dei Tumori
    B.5.2Functional name of contact pointTrial Center
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezian 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.4Telephone number0223903824
    B.5.5Fax number0223903991
    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 nameDacomitinib
    D.3.2Product code PF00299804
    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 INNDacomitinib
    D.3.9.2Current sponsor codePF00299804
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    locally advanced/metastatic squamous cell carcinoma of the penis
    Neoplasie spinocellulari del pene in fase localmente avanzata/metastatica
    E.1.1.1Medical condition in easily understood language
    locally advanced/metastatic squamous cell carcinoma of the penis
    Neoplasie spinocellulari del pene in fase localmente avanzata/metastatica
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the activity of Dacomitinib in squamous cell carcinoma of the penis
    Valutazione dell'attivita' di dacomitinib nelle neoplasie spinocellulari del pene
    E.2.2Secondary objectives of the trial
    Safety and toxicity
    Sicurezza e tossicita'
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Cytologically or histologically proven diagnosis of SCC of the penis.
    • Histologically (Tru-cut biopsy) proven diagnosis of loco-regional nodal disease will be required in all cases except for those with unequivocal lymphadenopathy.
    • Uni- or bidimensionally measurable disease.
    • Clinical stage N2-3 and/or M1 (TNM 2002).
    • Locoregional relapse after prior major surgery/ies (either single or multiple).
    • Age 18-75.
    • Written informed consent.
    • ECOG performance status of at least 1.
    • Neither prior chemotherapy nor treatment with any targeted agent.
    • No use of any investigational agents within 4 weeks of study inclusion.
    • Adequate bone marrow, liver and renal function.
    • Consenso informato scritto.
    • Età ≥ 18 anni.
    • ECOG performance status 0-1.
    • Diagnosi citologicamente o istologicamente confermata di carcinoma spinocellulare del pene (la conferma diagnostica di malattia linfonodale è richiesta in tutti i casi).
    • Malattia localmente avanzata/metastatica (stadio clinico N2-3 o M1 – TNM 2002).
    • Ricaduta/progressione dopo precedente chirurgia linfonodale.
    • Nessun precedente trattamento sistemico per la patologia oggetto di studio, ad esclusione del trattamento con VBM (vinblastina, bleomicina, methotrexate) per malattia superficiale se eseguito &lt; 6 mesi dal tempo di arruolamento in studio.
    • Malattia misurabile, definita come la presenza di ≥ 1 lesione misurabile uni-dimensionalmente con metodiche convenzionali (TC) di ≥ 2 cm o di ≥ 1 cm se misurata con TC spirale.
    • Adeguata funzione midollare, epatica e renale in accordo ai valori riportati in full protocol.
    • Aspettativa di vita di almeno 12 settimane.
    • Possibilità e disponibilità a seguire le procedure previste dal protocollo.
    E.4Principal exclusion criteria
    Excluded Medical Conditions
    • History of any one or more of the following cardiovascular conditions within the past 6 months:
    o Cardiac angioplasty or stenting.
    o Myocardial infarction.
    o Unstable angina.
    o Coronary artery by-pass graft surgery.
    o Symptomatic peripheral vascular disease.
    o Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
    o Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted).
    o Screening ECG with a QTc>450 msec, congenital long QT syndrome, history of sustained ventricular tachycardia, history of ventricular fibrillation or torsade de pointes, bradycardia defined as heart rate < 50 bpm (patients with a pacemaker and heart rate > 50 bpm are eligible).
    o Uncontrolled hypertension.
    • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug.
    • History of HIV infection or active chronic hepatitis B or C.
    • Active clinically serious infections (> grade 2 NCI-CTC version 4.0).
    • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics).
    • History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
    • Patients undergoing renal dialysis.
    • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma or any cancer curatively treated > 5 years prior to study entry.
    • Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
    • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
    • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
    • Patients unable to swallow oral medications.
    • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug.

    Excluded therapies and medications, previous and concomitant
    • Treatment with any of the following anti-cancer therapies:
    o radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of PF-299804 OR
    o chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of PF-299804.
    • (Palliative radiotherapy will be allowed).
    • Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study].
    • Prior exposure to study drug.
    Co-morbidità escluse:
    • Importanti patologie cardiovascolari nei 6 mesi che precedono l’inizio di PF-0299804, quali:
    o Infarto miocardico (IM), angina instabile (l’IM a più di 6 mesi dall’ingresso nello studio è ammesso), scompenso cardiaco di grado ≥ 2 secondo i criteri NYHA, aritmie di qualsiasi natura che richiedano l’uso di farmaci (beta-bloccanti o digossina sono permessi), ipertensione (PA media &gt; 140/90 mm/Hg) non controllata, prolungamento dell’intervallo QT (QTc) &gt; 450 msec.
    o Storia di infarti cerebro-vascolari, embolia polmonare o trombosi venosa profonda non trattata entro i 6 mesi che precedono l’inizio del protocollo.
    • Infezione da HIV o epatite cronica attiva di tipo B e C.
    • Infezioni clinicamente serie in fase attiva (di grado &gt; 2 dei CTCAE v.4.03).
    • Metastasi cerebrali o meningee sintomatiche (a meno di un tempo &gt; 6 mesi da un precedente trattamento curative e malattia clinicamente stabile al momento dell’ingresso nello studio).
    • Anamnesi positiva per crisi epilettiche che richiedono specifico trattamento medico (come cortico-steroidi e anti-epilettici).
    • Seconda neoplasia pregressa o concomitante fatta eccezione per il carcinoma in situ della cervice, il carcinoma basocellulare o qualsiasi altra neoplasia trattata in modo radicale ad un tempo &gt; 5 anni rispetto alla data di ingresso nello studio.
    • Presenza di infezione non controllata.
    • Nota ipersensibilità a farmaci chimicamente correlabili a PF-0299804.
    • Presenza di qualsiasi condizione medica, disfunzione metabolica o psichiatrica che possa limitare la piena osservanza delle procedure dello studio o aumentare il rischio associato all’assunzione del farmaco.

    Terapie oncologiche e altri farmaci esclusi, pregressi o concomitanti:
    • Ogni chemioterapia o immunoterapia sia durante il trattamento che precedenti.
    • Radioterapia, chirurgia o embolizzazione tumorale durante o entro 14 giorni dall’arruolamento nello studio (la radioterapia a scopo palliativo è ammessa).
    • Pregresso trattamento con PF-0299804.
    E.5 End points
    E.5.1Primary end point(s)
    Response rate
    Risposta obiettiva
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months
    2 mesi
    E.5.2Secondary end point(s)
    Number of adverse events, overall survival, progression free survival
    Numero di eventi avversi e sopravvivenza globale, sopravvivenza libera da progressione
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 months
    2 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy 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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months40
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state37
    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)
    Outpatients visits every 2 months
    Controlli ambulatoriali ogni 2 mesi
    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 Decision2012-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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