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    Summary
    EudraCT Number:2005-006022-29
    Sponsor's Protocol Code Number:A6181058
    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:2006-06-05
    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 number2005-006022-29
    A.3Full title of the trial
    RANDOMIZED, DOUBLE-BLIND, PHASE 2 STUDY OF ERLOTINIB WITH OR WITHOUT SU011248 IN THE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER
    STUDIO DI FASE II RANDOMIZZATO IN DOPPIO CIECO CON ERLOTINIB CON O SENZA SU011248 NEL TRATTAMENTO DEL CARCINOMA POLMONARE NON A PICCOLE CELLULE METASTATICO
    A.4.1Sponsor's protocol code numberA6181058
    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 SponsorPFIZER
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Sutent
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Capsule, hard
    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 INNSunitinib Malate
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number12.5
    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 typeNon Applicabile
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LTD
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Coated 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 INNerlotinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number150
    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 typeNon Applicabile
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LTD
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Coated 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 INNerlotinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number25
    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 typeNon Applicabile
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Sutent
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Capsule, hard
    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 INNSunitinib Malate
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number50
    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 typeNon Applicabile
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Platinum-refractory, locally advanced or metastatic non-small cell lung cancer (NSCLC)
    Pazienti con diagnosi di carcinoma polmonare non a piccole cellule (NSCLC) metastatico o localmente avanzato, refrattari al platino
    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 PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    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 compare the progression-free survival (PFS) for SU011248 plus erlotinib versus placebo plus erlotinib in patients with platinum-refractory NSCLC.
    Confrontare la sopravvivenza libera da progressione (PFS) del SU011248 associato a erlotinib vs placebo associato a erlotinib in pazienti affetti da carcinoma polmonare non a piccole cellule refrattari al platino.
    E.2.2Secondary objectives of the trial
    To compare the objective response rate (ORR) for SU011248 plus erlotinib versus placebo plus erlotinib as treatment for platinum-refractory NSCLC. To evaluate measures of duration of tumor control and compare survival. To compare the safety and tolerability of SU011248 plus erlotinib versus placebo plus erlotinib. To evaluate the plasma pharmacokinetics of erlotinib and SU011248 and its active metabolite SU012662 when these drugs are co-administered. To explore the relationships of cancer biomarkers with cancer- and treatment-related outcomes. To compare patient reported outcomes (PRO) including health-related quality of life (HRQOL) and lung cancer-related symptoms in patients treated with SU011248 plus erlotinib versus placebo plus erlotinib.
    1.Confrontare la percentuale di risposta obiettiva (ORR) del SU011248 / erlotinib versus placebo/erlotinib in pazienti affetti da NSCLC refrattari al platino.2.Valutare il controllo della crescita tumorale in termini di durata e comparare la sopravvivenza.3.Confrontare la sicurezza e la tollerabilita` del SU011248 associato all erlotinib vs placebo/ erlotinib.4.Valutare la farmacocinetica nel plasma di erlotinib e SU011248 e del suo metabolita attivo SU012662 quando questi farmaci sono somministrati in associazione.5.Indagare la correlazione dei biomarkers tumorali con il tumore ed I risulatati correlati al trattamento.6.Valutare i cambiamenti nella qualita` di vita correlata allo stato di salute e nella sintomatologia (HRQOL) nei pazienti trattati con SU011248 /erlotinib vs quella dei pazienti trattati con placebo/erlotinib.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:
    Date:
    Title:
    Objectives:

    FARMACOGENETICA:
    Vers:
    Data:
    Titolo:
    Obiettivi:

    E.3Principal inclusion criteria
    1. Histologically proven diagnosis of NSCLC. 2. Disease that is locally advanced (Stage IIIB with malignant effusion), metastatic (Stage IV), or recurrent (after treatment for Stage IIIB with malignant effusion or Stage IV NSCLC). 3. Prior treatment with 1 or 2 chemotherapy regimens including a platinum-based regimen for advanced disease (Stage IIIB with malignant effusion or Stage IV). 4. Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST). 5. Radiographic evidence of disease progression during or following treatment in the advanced disease setting confirmed by the Principal Investigator prior to enrollment in the study. 6. Formalin-fixed, paraffin-embedded tumor tissue available from patients enrolling into the randomized component of this study. (Paired samples collected at the time of the most recent recurrence and at the initial diagnosis are optimal, though samples collected at any time are acceptable). 7. Male or female, 18 years of age or older. Note: Patients enrolled into the lead-in cohort must be <70 years of age. 8. ECOG performance status 0 or 1. 9. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade </=1 (except alopecia). 10. Adequate organ function as defined by the following criteria: - NCI CTCAE severity </= 2 for dyspnea - Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) </=2.5 x upper limit of normal (ULN), or AST and ALT </=5 x ULN if liver function abnormalities are due to underlying malignancy - Total serum bilirubin </=1.5 x ULN - Serum albumin >/=3.0 g/dL - Absolute neutrophil count (ANC) >/=1500/uL - Platelets >/=100,000/&#61549;L - Hemoglobin >/=9.0 g/dL - Serum creatinine </=1.5 x ULN 11. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. 12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
    1. Diagnosi istologicamente confermata di carcinoma polmonare non a piccole cellule. 2. Malattia localmente avanzata (Stadio IIIB con versamento neoplastico), metastatica (Stadio IV), o ricorrente (dopo trattamento per lo Stadio IIIB con versamento neoplastico o Stadio IV ). 3. Precedente trattamento con 1 o 2 regimi chemioterapici incluso un regime contenente platino per la malattia in stadio avanzato (Stadio IIIB con versamento neoplastico o Stadio IV). 4. Evidenza di malattia unidimensionalmente misurabile secondo i Criteri per la Valutazione della Risposta nei Tumori Solidi (RECIST). 5. Evidenza radiografica di progressione di malattia durante o dopo il trattamento per lo stadio avanzato confermata dallo Sperimentatore prima dell¿arruolamento nello studio. 6. Disponibilita` del reperto bioptico dei pazienti che verranno arruolati nella fase randomizzata dello studio. 7. Soggetti di sesso maschile o femminile di eta`&gt;18 anni. 8. Performance status 0 or 1 secondo ECOG. 9. Risoluzione di tutti gli effetti tossici acuti determinati da precedenti terapie sistemiche, o interventi chirurgici a grado&lt;/=1 (eccetto l¿alopecia). 10. Adeguata funzionalita` d¿organo come definita dai seguenti criteri: ¿ Severita` della dispnea &lt;/= 2 secondo NCI CTCAE. ¿ AST e ALT &lt;/=2.5 x ULN, o AST e ALT &lt;/=5 x ULN se I valori alterati della funzionalita` epatica siano dovuti alla malattia neoplasica. ¿ Bilirubina totale sierica &lt;/=1.5 x ULN ¿ Albumina sierica &gt;/=3.0 g/dL ¿ Conta assoluta dei neutrofili (ANC) &gt;/=1500/uL ¿ Piastrine &gt;/=100,000/&#61549;L ¿ Emoglobina &gt;/=9.0 g/dl ¿ Creatinina sierica &lt;/=1.5 x ULN 11. Consenso informato scritto per testimoniare che il paziente (o il suo rappresentante legale) sia stato informato degli aspetti rilevanti dello studio prima dell¿arruolamento. 12. Disponibilita` e possibilita` ad effettuare visite mediche programmate, esami di laboratorio e a seguire le procedure dello studio.
    E.4Principal exclusion criteria
    1. Prior treatment with >2 systemic chemotherapy-based regimens for advanced disease (Stage IIIB with malignant effusion or Stage IV). 2. Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenic inhibitors (including but not limited to SU011248, erlotinib, gefitinib, or thalidomide). Note: Patients previously treated with bevacizumab or an IGFR inhibitor will be considered eligible for study entry. Note: Patients previously treated with cetuximab will not be considered eligible for study entry. 3. Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment. At least 7 days should elapse since minor surgical procedure including placement of an access device or fine needle aspiration. 4. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue. 5. Prior radiation therapy to >25% of the bone marrow. 6. Evidence of hemoptysis <4 weeks of starting study treatment. Patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 mL of blood per episode and less than 10 mL of blood per 24-hour period in the best estimate of the investigator. 7. History of or known brain metastases, spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomenengeal disease on screening CT or MRI scan. 8. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma. 9. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolism. 10. Ongoing cardiac dysrhythmias of NCI CTCAE grade >/=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females. 11. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy). 12. Current treatment with therapeutic doses of coumarin-derivative anticoagulants such as warfarin (however low dose up to 2 mg daily for deep vein thrombosis prophylaxis is allowed during the Phase 2 component of this study but not during the lead-in portion) or anti-vitamin K agents. If currently receiving prophylaxis, PT or INR must be <1.5 times the ULN. 13. Known human immunodeficiency virus (HIV) infection. 14. Current treatment on another therapeutic clinical trial. 15. Pregnancy or breastfeeding. Female patients who are pregnant or nursing, or men and women of reproductive potential who are unwilling or unable to use adequate contraception to prevent pregnancy during the program. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to study entry. 16. Patients with severe dry eye syndrome, Sjogren¿s syndrome, severe exposure keratopathy, bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis, clinically significant gastrointestinal abnormalities including uncontrolled inflammatory disease (e.g. Crohn¿s or ulcerative colitis). 17. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    1. Precedente trattamento con &gt;2 regimi di chemioterapia sistemica per la malattia avanzata (Stadio IIIB con versamento neoplastico o Stadio IV). 2. Precedente trattamento con inibitori del recettore della tirosin chinasi, o con inibitori del VEGF, o inibitori dell¿angiogenesi (compresi ma non limitati al SU011248, erlotinib, gefitinib, o alla talidomide). N.B.: I pazienti precedentemente trattati con bevacizumab o con un inibitore del recettore IGF saranno considerati eleggibili. 3. Interventi di chirurgia maggiore, radioterapia, o terapia sistemica entro le 4 settimane dall¿inizio del trattamento in studio. 4. Precedente chemioterapia ad alte dosi che richiede trapianto di cellule staminali. 5. Precedente radioterapia a &gt;25% del midollo osseo. 6. Evidenza di emottisi nelle 4 settimane l¿inizio del trattamento in studio. I pazienti con sputo velato o striato di sangue saranno eleggibili se la quantita` di sangue sara` inferiore a 5 mL per episodio ed inferiore a 10 mL nelle 24 ore secondo la stima dello sperimentatore. 7. Anamnesi di metastasi cerebrali o compressione spinale o meningite carcinomatosa o evidenza allo screening mediante TAC o risonanza magnetica, di malattia cerebrale o leptomeningea 8. Diagnosi di altri tumori maligni negli ultimi 3 anni, eccetto per il basotelioma e del tumore a cellule squamose della pelle o il carcinoma in situ della cervice uterina che siano stati adeguatamente trattati. 9. Angina instabile o grave, infarto del miocardio, bypass coronarico, insufficienza cardiaca congestizia , embolia polmonare, o grave evento cerebrovascolare nei 12 mesi precedenti l¿inizio del trattamento in studio. 10. Aritmie cardiache in corso di grado &gt;/=2 secondo NCI CTCAE, fibrillazione atriale di qualsiasi grado, o intervallo QTc &gt;450 msec per gli uomini o &gt;470 msec per le donne. 11. Ipertensione non controllata da terapia farmacologica (&gt;150/100 mmHg nonostante la terapia medica ottimale). 12. Trattamento in corso con dosi terapeutiche di warfarin (tuttavia sono permesse bassi dosi di warfarin sino a 2 mg al giorno per la profilassi della trombosi venosa profonda durante la seconda fase dello studio, ma non in quella preliminare (lead in ). 13. Infezione HIV documentata. 14. Trattamento in corso in un altro studio clinico. 15. Gravidanza o allattamento. 16. I pazienti con sindrome di occhio asciutto grave, sindrome di Sjögren, esposizione grave cheratopatia, cheratopatia bollosa, aniridia, gravi ustioni chimiche, o cheratite neutrofila, alterazioni gastrointestinali clinicamente significative, inclusi malattia infiammatoria incontrollata (es. Crohn o la colite ulcerosa) 17. Condizioni cliniche gravi acute o croniche o stati psichiatrici o valori di laboratorio alterati che potrebbero aumentare i rischi associati alla partecipazione allo studio o al trattamento in studio o interferire con l¿interpretazione dei risultati dello studio o a giudizio dello sperimentatore rendere il paziente non idoneo a parteciparvi.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-Free Survival (PFS)
    Sopravvivenza libera da progressione (PFS)
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    SU011248/erlotinib vs placebo/erlotinib
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Yes
    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 months51
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months51
    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.1.1Number 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.1.3Elderly (>=65 years) Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 165
    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 Decision2006-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
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