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    Summary
    EudraCT Number:2008-000814-65
    Sponsor's Protocol Code Number:PACT-12
    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:2008-03-10
    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 number2008-000814-65
    A.3Full title of the trial
    Maintenance therapy with Sunitinib in pancreatic adenocarcinoma metastatic: Phase II randomized trial.
    Terapia di mantenimento con Sunitinib nell'adenocarcinoma pancreatico metastatico: studio randomizzato di fase II
    A.4.1Sponsor's protocol code numberPACT-12
    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 SponsorOSPEDALE S. RAFFAELE DI MILANO
    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 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*30CPS 12,5MG
    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.3.4Pharmaceutical 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 INNNA
    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 type L'IMP è un agente antineoplastico: inibitore delle protein-tirosin chinasi
    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 SUTENT*30CPS 25MG
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA Srl
    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.3.4Pharmaceutical 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 INNNA
    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 type L'IMP è un agente antineoplastico: inibitore delle protein-tirosin chinasi
    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
    Pancreatic adenocarcinoma metastatic
    Adenocarcinoma pancreatico metastatico
    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 LLT
    E.1.2Classification code 10033599
    E.1.2Term Pancreatic adenocarcinoma metastatic
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate progression free survival at 6 months (PFS-6) from the beginning of the trial in patients affected by pancreatic metastatic adenocarcinoma free of progression after 6 months first line chemiotherapy and underwent maintenance therapy.
    Valutare la sopravvivenza libera da progressione a 6 mesi (PFS-6) dall'entrata nello studio nei pazienti affetti da adenocarcinoma pancreatico metastatico liberi da progressione dopo 6 mesi di chemioterapia di prima linea e sottoposti a terapia di mantenimento con Sunitinib rispetto ai pazienti non sottoposti a terapia di mantenimento.
    E.2.2Secondary objectives of the trial
    To evaluate overall survival, response rate, response time, toxicities to treatment, and the impact on quality of life in patients enrolled in the trial.
    Valutare la sopravvivenza globale,il tasso di risposte,la durata delle risposte,la tossicita' del trattamento,e l'impatto sulla qualita' di vita dei pazienti arruolati nello studio.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ALTRI SOTTOSTUDI:
    Studio ancillare per esplorare il ruolo di alcune proteine plasmatiche (VEGF, VEGFR-2, VEGFR-3, TSP-1, PIGF), del polimorfismo genico di VEGF ed espressione genica dei fattori sopra indicati.
    E.3Principal inclusion criteria
    1. Cytological or histological diagnosis of pancreatic adenocarcinoma
    2. Presence of metastatic disease
    3. No previous chemiotherapy, except induction therapy, for pancreatic neoplasia.
    4. Demonstrated progression absence at 6 months since the beginning of chemiotherapic treatment, indipendently from the used scheme and from the response entity (stable disease, partial response, complete response):
    a. normal value or not increasing more than 20 % respect to previous evaluation of tumor marker (CA19.9 or CEA). The previous evaluation should be performed at least 30 days before.
    b. Two consecutive CT scan or MRI evaluations within at least 6 weeks, that document pregression absence according to RECIST criteria (NO increase > 20% of the sum of the longest diameter of all target lesions; NO new lesions; NO evident progression of any pre-existing non-target lesion)
    5. Interval not shorter that 3 weeks and not longer than 8 weeks since the last chemiotherapy administration (an interval not shorter than one week since the end of capecitabine or 5FU administration in continuous infusion is sufficient)
    6. No duodenal or gastric or intestinal infiltration documented by CT scan or RMI.
    7. CT scan or RMI performed within 3 weeks before enrollment
    8. NO previous therapy with other antiangiogenic drugs (for instance: bevacizumab, sorafenib, pazopanib,AZD2171, vatalanib, VEGF trap,sunitinib)
    9. Age > 18 years
    10. Karnofsky performance status > 50%
    1. Diagnosi citologica o istologica di adenocarcinoma pancreatico
    2. Presenza di malattia metastatica
    3. Non precedenti trattamenti chemioterapici, oltre alla terapia di induzione, per la neoplasia pancreatica
    4. Dimostrazione di assenza di progressione a 6 mesi dall'inizio del trattamento chemioterapico di induzione, indipendentemente dallo schema utilizzato e dall'entita' della risposta (malattia stazionaria, risposta parziale, risposta completa):
    a. marcatore tumorale (CA19.9 o CEA) nella norma o non in aumento &gt;20% rispetto alla precedente determinazione eseguita almeno 30 giorni prima
    b. 2 TC o RM consecutive, distanziate di almeno 6 settimane, che documentino l'assenza di progressione secondo i criteri RECIST (NON aumento &gt; 20% della somma del diametro maggiore di tutte le lesioni bersaglio; NON comparsa di una o piu' nuove lesioni; NON progressione evidente di una lesione non bersaglio pre-esistente)
    5. Intervallo non inferiore alle 3 settimane e non superiore alle 8 settimane dall'ultima somministrazione di chemioterapia (e' sufficiente un intervallo non inferiore alla settimana dal termine della somministrazione di capecitabina o di 5FU in infusione continua)
    6. Non infiltrazione duodenale o gastrica o intestinale documentata con TC o RM
    7. TC o RM effettuate entro le tre settimane antecedenti l'arruolamento nello studio
    8. Non precedente terapia con altri farmaci antiangiogenetici (per es: bevacizumab, sorafenib, pazopanib, AZD2171, vatalanib, VEGF trap, sunitinib)
    9. Eta' &gt;18 anni
    10. Karnofsky performance status &gt; 50%
    E.4Principal exclusion criteria
    History of hypertension except if well controlled or with antihypertensive therapy.
    Major surgery in the month before study entry and complete recovery of surgical intervention.
    Concomitant intake or at least 7 days interval from CYP3A4 inhibitors stop (antifungal azolic such as ketoconazole, itraconazole, diltiazem, claritromicine, eritromicine, verapamil, delavirdine, HIV protease inhibitors such as indinavir, saquinavir, ritonavir, atazanavir, nelfinavir).
    Concomitant intake or at least 12 days interval from CYP3A4 inducer stop(rifampine, rifabutine, carbamazepina, fenobarbital, fenitoine, hypericum perforatum, efavirenz, tipranavir).
    Concomitant intake of drugs with antiarrhythmic potential (terfenadine, quinidine, procainamide, disopiramide, solatole, probucole, bepridil, aloperidol, risperidone, indapamide, flecainide)
    Concomitant intake of therapeutic doses of anticoagulant drugs derived from warfarin (warfarin at < 2 mg/die doses or low molecular weight heparins for patients with INR < 1.5 for prophilaxis of thrombosis are allowed)
    Previous or concomitant neoplasia, except carcinoma in situ of uterine cervix and skin epidermoidal carcinoma appropriately treated or other neoplasms if the patient has been disease free for at least 5 years.
    Concomitant treatment with other investigational drugs, or hormones or radiotherapy
    Anamnesi positiva per ipertensione tranne se ben controllata o in terapia antiipertensiva
    Chirurgia maggiore nel mese precedente l'entrata in studio e recupero completo dall'atto chirurgico
    Concomitante assunzione o intervallo di almeno 7 giorni dalla sospensione degli inibitori di CYP3A4 (antifungini azolici come ketoconazolo o itraconazolo, diltiazem, claritromicina, eritromicina, verapamil, delavirdina, inibitori proteasi HIV come indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
    Concomitante assunzione o intervallo di almeno 12 giorni dalla sospensione degli induttori di CYP3A4 (rifampin, rifabutin, carbamazepina, fenobarbital, fenitoina, hypericum perforatum, efavirenz, tipranavir)
    Concomitante assunzione di farmaci con potenziale antiaritmico (terfenadina, quinidina, procainamide, disopiramide, sotalolo, probucolo, bepridil, aloperidolo, risperidone, indapamide, flecainide)
    Concomitante assunzione di dosi terapeutiche di anticoagulanti derivati della warfarina (warfarina a dosi &lt; 2 mg/die o eparine a basso peso molecolare per i pazienti con INR &lt; 1.5 per il trattamento profilattico della trombosi sono consentiti)
    Precedenti o concomitanti neoplasie, escluso il carcinoma in situ della cervice uterina ed i carcinomi epidermoidali della cute trattati adeguatamente o altre neoplasie se il paziente e' stato libero da malattia per almeno 5 anni
    Concomitante trattamento con altri farmaci sperimentali, con ormoni o radioterapia
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the rate of patients free from progression at 6 months since the enrollment date (PFS-6).
    L' endpoint dello studio e' il tasso di pazienti liberi da progressione a 6 mesi dalla data di arruolamento nello studio (PFS-6).
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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
    nessuna terapia
    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 concerned17
    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 years2
    E.8.9.1In the Member State concerned months0
    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.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-03-10. Yes
    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 state52
    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 Decision2008-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
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