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    Summary
    EudraCT Number:2011-005724-17
    Sponsor's Protocol Code Number:AFLIBC06097
    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:2012-06-28
    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 number2011-005724-17
    A.3Full title of the trial
    A Multicenter, Single arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients with Metastatic Colorectal Cancer (mCRC) Previously Treated with an Oxaliplatin-Containing Regimen
    Studio multicentrico, a singolo braccio, in aperto per valutare la sicurezza e la qualita' della vita (relativamente allo stato di salute) correlati ad aflibercept in pazienti affetti da tumore del colon-retto metastatico (mCRC), precedentemente trattati con un regime terapeutico contenente oxaliplatino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Quality of Life study of Aflibercept in patients with metastatic Colorectal Cancer previously treated with an oxaliplatin-based regimen
    Studio sulla sicurezza e la Qualita' della Vita di Aflibercept in pazienti con tumore metastatico del colon retto trattato precedentemente con una terapia a base di oxaliplatino
    A.4.1Sponsor's protocol code numberAFLIBC06097
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1125-8949
    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 SponsorSANOFI-AVENTIS GROUPE
    B.1.3.4CountryFrance
    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 supportSanofi Aventis Groupe
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis SpA
    B.5.2Functional name of contact pointcontact point
    B.5.3 Address:
    B.5.3.1Street AddressVle Bodio, 37/b
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800.226343
    B.5.5Fax number02.3939.4168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi-aventis.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 nameaflibercept
    D.3.2Product code AVE0005
    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.3.9.1CAS number 862111-32-8
    D.3.9.2Current sponsor codeAVE0005
    D.3.9.3Other descriptive nameVEGF TRAP
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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.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 Yes
    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 typeporzioni extracellulari recettore VEGF ) fuse con la porzione Fc dell’ IgG1 umana
    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
    Colorectal Neoplasms
    Tumore del colon retto
    E.1.1.1Medical condition in easily understood language
    Colorectal Neoplasms
    Tumore del colon retto
    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 10052358
    E.1.2Term Colorectal 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
    To provide mCRC patients (similar to the patients evaluated in the VELOUR phase III trial) and Investigators with access to aflibercept, prior to its marketing authorisation and/or commercial availability and to document the aflibercept overall safety in this patient population.
    Fornire ai pazienti affetti da mCRC (con caratteristiche simili ai pazienti valutati nello studio clinico di fase III VELOUR) e agli sperimentatori l’accesso ad aflibercept prima dell’ autorizzazione alla commercializzazione e/o disponibilità in commercio e documentare il profilo di sicurezza di aflibercept in questi pazienti
    E.2.2Secondary objectives of the trial
    To document the Health-Related Quality of Life (HRQL) of aflibercept in this patient population
    Documentare la qualità della vita (relativamente allo stato di salute) (HRQL) in questi pazienti,durante il trattamento con aflibercept.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically or cytologically proven adenocarcinoma of the colon or rectum Metastatic disease Eastern Cooperative Oncology Group performance status 0-1 One and only one prior chemotherapeutic regimen for metastatic disease. This prior chemotherapy must be an oxaliplatin containing regimen. Patients must have progressed during or after the oxaliplatin based chemotherapy. Patients relapsed within 6 months of completion of oxaliplatin adjuvant chemotherapy are eligible
    - Adenocarcinoma del colon o del retto, confermato istologicamente o citologicamente - Malattia metastatica - Età ≥18 anni - ECOG PS 0-1 - Uno ed un solo precedente regime chemioterapico per la malattia metastatica. Questo precedente regime chemioterapico deve contenere oxaliplatino. I pazienti devono aver avuto una progressione di malattia durante o dopo l’ultima somministrazione della chemioterapia contenente oxaliplatino. Sono eleggibili anche i pazienti che presentano recidiva entro 6 mesi dal completamento della chemioterapia adiuvante contenente oxaliplatino
    E.4Principal exclusion criteria
    Prior therapy with irinotecan Inadequate bone marrow, liver and renal function: neutrophils < 1.5x109/L, platelets < 100x109/L, hemoglobin < 9.0 g/dL, total bilirubin >1.5 x upper normal limit (ULN), transaminases >3 x ULN (unless liver metastasis are present), alkaline phosphatase >3 x ULN (unless liver metastasis are present), serum creatinine > 1.5 x ULN. Less than 4 weeks from prior radiotherapy, prior chemotherapy, prior major surgery (or until the surgical wound is fully healed). Treatment with any investigational drug within the prior 30 days. Treatment with concomitant anticonvulsivant agents that are CYP3A4 inducers (phenytoin, phenobarbital, carbamazepine), unless discontinued >7 days. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease. Prior malignancy (other than colorectal) including prior malignancy from which the patient has been disease free for < 5 years (except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix). Any of the following within 6 months prior to study inclusion: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, severe congestive heart failure, stroke or transient ischemic attack. Any of the following within 3 months prior study inclusion: severe gastrointestinal bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event. Occurrence of deep vein thrombosis within 4 weeks, prior to study inclusion. Known dihydropyrimidine dehydrogenase deficiency. Predisposing colonic or small bowel disorders in which the symptoms were uncontrolled. Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhea, unresolved bowel obstruction/sub-obstruction, more than hemicolectomy, extensive small intestine resection with chronic diarrhea. Known Gilbert’s syndrome. Unresolved or unstable toxicity from any prior anti cancer therapy at the time of inclusion. History of anaphylaxis or known intolerance to atropine sulphate or loperamide or appropriate antiemetics to be administered in conjunction with FOLFIRI (irinotecan, 5-Fluorouracil, leucovorin). Severe acute or chronic medical condition, which could impair the ability of the patient to participate to the study. Urine protein-creatinine ratio (UPCR) >1 on morning spot urinalysis or proteinuria > 500 mg/24-h. Uncontrolled hypertension within 3 months prior to study inclusion. Patients on anticoagulant therapy with unstable dose of warfarin and/or having an out-of-therapeutic range INR within the 4 weeks prior to study inclusion. Evidence of clinically significant bleeding predisposition or underlying coagulopathy, non-healing wound. Pregnant or breast-feeding women. Patients with reproductive potential who do not agree to use an accepted effective method of contraception.
    -Precedente terapia con irinotecan -Inadeguata funzionalità midollare, epatica e renale: •Conta assoluta dei neutrofili (ANC) &lt; 1.5 x 109/L •Piastrine &lt; 100 x 109/L •Emoglobina &lt; 9.0 g/dL •Bilirubina totale &gt; 1.5 x ULN •Transaminasi &gt; 3 x ULN (o &gt; 5 x ULN in caso di presenza di metastasi epatiche) •Fosfatasi alcalina &gt; 3 x ULN (o &gt; 5 x ULN in caso di presenza di metastasi epatiche). -Meno di 4 settimane trascorse da un precedente trattamento radioterapico o chemioterapico, o precedente intervento di chirurgia maggiore (o fino cicatrizzazione completa della ferita chirurgica) -Trattamento con qualsiasi farmaco sperimentale nei 30 giorni precedenti -Trattamento concomitante con anticonvulsivi induttori del citocromo CYP3A4 (fenitoina, fenobarbitale, carbamazepina), se non interrotti da più di 7 giorni. -Anamnesi di metastasi cerebrali, compressione midollare non controllata, o carcinomatosi meningea o evidenza di nuova malattia cerebrale o leptomeningea. -Anamnesi di neoplasie maligne in altre sedi ad eccezione del carcinoma cutaneo basocellulare o a cellule squamose adeguatamente trattato e del carcinoma in situ della cervice; sono inoltre eleggibili pazienti con altre neoplasie maligne con intervallo libero da malattia superiore a 5 anni. -Uno qualsiasi dei seguenti eventi nei 6 mesi precedenti l’inclusione: infarto del miocardio, angina pectoris grave/instabile, bypass aortocoronarico o periferico, scompenso cardiaco congestizio grave, ictus o TIA-Uno qualsiasi dei seguenti eventi nei 3 mesi precedenti l’inclusione: gravi emorragie/sanguinamenti gastrointestinali , ulcera peptica resistente al trattamento, esofagite o gastrite erosiva, malattia intestinale di eziologia infettiva o infiammatoria, diverticolite, embolia polmonare o qualsiasi evento tromboembolico non controllato -Trombosi venosa profonda nelle 4 settimane precedenti l’inclusione. --Deficit noto di diidropirimidina deidrogenasi -Predisposizione a malattie del colon o del piccolo intestino i cui sintomi non siano controllati -Anamnesi di enteropatia cronica, enteropatia infiammatoria, diarrea cronica, ostruzione/subostruzione dell’intestino non risolta, resezione più estensiva rispetto ad emicolectomia, resezione estesa dell’intestino tenue con diarrea cronica -Pazienti affetti da sindrome di Gilbert nota. -Tossicità non risolta o instabile al momento dell'inclusione derivante da un precedente trattamento oncologico -Anamnesi di anafilassi o nota intolleranza ad atropina solfato o loperamide o antiemetici adeguati per la somministrazione in associazione a FOLFIRI (irinotecan, 5-fluoracile, leucovorina) -Altre condizioni mediche gravi, acute o croniche, che possano limitare la capacità del paziente di partecipare allo studio -Rapporto Proteine-Creatinina urinaria (UPCR) &gt;1 sul campione di urine mattutino o proteinuria &gt;500 mg/24ore. - Ipertensione non controllata nei 3 mesi precedenti l’inclusione nello studio.-Pazienti in terapia con anticoagulanti con dose non stabile di warfarina e/o che presentino un valore di INR al di fuori del range terapeutico (&gt;3) nelle 4 settimane precedenti l’inclusione. -Evidenza clinica di diatesi emorragica o coagulopatia, ferite che non cicatrizzano. -Donne in gravidanza o in allattamento. -Pazienti in età fertile (di sesso maschile e femminile) che non accettino di utilizzare un metodo di contraccezione approvato.
    E.5 End points
    E.5.1Primary end point(s)
    Number of participants reporting adverse events - Number of participants reporting laboratory abnormalities
    Numero di partecipanti con eventi avversi e/o con valori di laboratorio anormali
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 30 days after the end of treatment
    Fino a 30 giorni dopo la fine del trattamento
    E.5.2Secondary end point(s)
    Health-Related Quality of Life (HRQL) assessed by using changes from baseline in scores derived from the 3 HRQL questionnaires
    - Valutazione della qualità della vita (relativamente allo stato di salute) (HRQL) sulla base dei cambiamenti, rispetto al basale, dei punteggi derivanti dai 3 questionari (HRQL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 4 weeks
    ogni 4 settimane
    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 No
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other 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 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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Chile
    Colombia
    India
    Israel
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    In each country, patient recruitment will end when aflibercept becomes commercially available (i.e. accessible to the patient as per each country regulation). Patients already included will continue to be treated until disease progression, death, unacceptable toxicity, Investigator’s decision or patient’s refusal of further treatment.
    In ogni Paese l'inclusione dei pz. continuerà fino a commercializzazione di aflibercept. I pz già inclusi continueranno il trattamento fino a progressione di malattia, morte, tossicità inaccettabile, decisione dello Sperimentatore o rifiuto del pz.
    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 months24
    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 months24
    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.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 900
    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
    none
    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 Decision2012-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
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