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    Summary
    EudraCT Number:2014-000777-38
    Sponsor's Protocol Code Number:SOAP
    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:2014-03-21
    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 number2014-000777-38
    A.3Full title of the trial
    Activity and safety of second line SOrafenib After Pazopanib in patients with metastatic renal cell carcinoma (SOAP Study)
    Attività e sicurezza della seconda linea con sorafenib dopo pazopanib nei pazienti con carcinoma renale metastatico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evalueta the activity and safety of sorafenib when used as second line of therapy after pazopanib in patients affected by metastatic renal cell carcinoma.
    Studio per valutare l'efficacia e la sicurezza del farmaco sorafenib utilizzato dopo pazopanib in pazienti affetti da tumore del rene metastatico
    A.3.2Name or abbreviated title of the trial where available
    SOAP
    SOAP
    A.4.1Sponsor's protocol code numberSOAP
    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 IRCCS Istituto Nazionale dei Tumori
    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 supportnone
    B.4.2CountryItaly
    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 pointtrialcenter
    B.5.3 Address:
    B.5.3.1Street Addressvia Venezian 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.6E-mailtrialcenter@istitutotumori.mi.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 Nexavar
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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 nameNexavar
    D.3.2Product code L01XE05
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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
    E.1.1.1Medical condition in easily understood language
    metastatic renal cell carcinoma
    tumore del rene metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10067946
    E.1.2Term Renal cell carcinoma
    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
    To evaluate the efficacy of sorafenib (PFS) as second line of treatment in patients treated with pazopanib for mRCC.
    Valutare l'efficacia di sorafenib come trattamento di seconda linea in pazienti già trattati con pazopanib
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of sorafenib in patients previously treated with pazopanib
    • To evaluate the Overall Survival
    • To evaluate the Quality of Life through specific questionnaires (FKSI-19; EORTC QLQ-C30).
    sicurezza, sopravvivenza globale e qualità della vita
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 years
    • Patients with hystological diagnosis of Renal Cell Carcinoma (RCC)
    • Measurable disease
    • ECOG Performance Status of 0 or 1
    • Life expectancy of at least 12 weeks.
    • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
    - Hemoglobin  10.0 g/dl
    - Absolute neutrophil count (ANC) >1,500/mm3
    - Platelet count  100,000/ml
    - Total bilirubin ≤ 1.5 times the upper limit of normal
    - ALT and AST ≤ 2.5 x upper limit of normal
    - Alkaline phosphatase ≤ 4 x ULN
    - PT-INR/PTT ≤ 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care.
    • Prognosis according to Heng: good or intermediate
    • Previous treatment with pazopanib
    • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
    • Signed informed consent must be obtained prior to any study specific procedures
    • Età ≥ 18 anni
    • Pazienti con diagnosi istologica di carcinoma renale (RCC)
    • Malattia metastatica misurabile
    • ECOG Performance Status di 0 o 1
    • Aspettativa di vita di almeno 12 settimane.
    • Adeguata funzionalità midollare epatica e renale come dimostrato dai parametri ematici eseguiti alla visita di screening e che devono essere:
    - Emoglobina  10.0 g/dl
    - Conta dei neutrofili (ANC) >1,500/mm3
    - Conta Piastrinica  100,000/ml
    - Bilirubina totale ≤ 1.5 x il limite superiore di normalità
    - ALT e AST ≤ 2.5 x il limite superiore di normalità
    - Fosfatasi alcalina ≤ 4 x il limite superiore di normalità
    - PT-INR/PTT ≤ 1.5 x il limite superiore di normalità [pazienti in corso di terapia eparinica o con coumadin possono partecipare allo studio se questi parametri non erano alterati prima dell’inizio della terapia anticoagulante] Per i pazienti in trattamento con farfari un monitoraggio settimane dell’INR è raccomandato fino a stabilizzazione dei valori.
    • Categoria prognostica secondo Heng: buona o intermedia
    • Precedente trattamento con pazopanib
    • Le donne in età fertile devono avere un test di gravidanza negative nei 7 giorni precedenti l’inizio della terapia. Sia uomini che donne in età fertile arruolati nel seguente studio devono adottare adeguati sistemi di protezione durante il corso del trattamento e per le due settimane successive all’interruzione.
    • Il consenso informato scritto deve essere ottenuto prima di ogni procedura relative allo studio.
    E.4Principal exclusion criteria
    • First line treatment for metastatic RCC other than pazopanib.
    • History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension (>= 160 mmHg systolic and/or 90 mmHg diastolic).
    • History of HIV infection
    • Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
    • Brain or meningeal metastases
    • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
    • History of organ allograft
    • Patients with evidence or history of bleeding diasthesis
    • Patients undergoing renal dialisis
    • History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
    • 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, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
    • Prima linea di trattamento diversa da pazopanib.
    • Storia di patologie cardiache: insufficienza cardiaca congestizia classe NYHA > 2; Coronaropatia in fase attiva (IMA nei sei mesi precedente la terapia); aritmia richiedente specifica terapia (beta beta bloccanti o digossina sono permessi) o ipertensione incontrollata (sistolica ≥ 160 mmHg e/o diastolica ≥ 90 mmHg).
    • Infezione da HIV
    • Infezioni in fase attiva (> grado 2 NCI-CTC versione 3.0)
    • Presenza di metastasi encefaliche o meningee
    • Paziente con storia di crisi epilettiche che richiedono terapie specifiche (come steroidi e/o antiepilettici)
    • Storia di trapianto d’organo
    • Pazienti con evidenza di emorragie o diastasi
    • Pazienti in corso di dialisi
    • Storia di malattie come disfunzioni metaboliche , anomalie all’esame fisico o laboratoristici che possano far sospettare per la presenza di condizioni di malattia sottostante che possano controindicare l’uso del farmaco oggetto di studio o che possano mettere il paziente a rischio di tossicità.
    • Precedente o concomitante diagnosi di cancro distinto per il sito primario o per la forma istologica con l’eccezione del carcinoma cervicale in situ, il carcinoma a cellule basale trattato, il tumore superficiale della vescica [Ta, Tis & T1] o ogni tumore trattato in maniera curativa in un periodo di tempo superiore a 3 anni precedenti lo studio.

    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of sorafenib (PFS) as second line of treatment in patients treated with pazopanib for mRCC.
    Valutazione dell'efficacia di sorafenib come trattamento di seconda linea in pazienti con carcinoma renale metastatico trattati con pazopanib
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 anno
    E.5.2Secondary end point(s)
    safety, Overall survival and quality of life
    sicurezza, sopravvivenza globale e qualità della vita
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 months
    18 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 No
    E.6.4Safety No
    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 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 Yes
    E.8.1.7.1Other trial design description
    a braccio singolo
    single arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned10
    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
    lvls
    lvls
    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.1.1.1In 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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state44
    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)
    standard clinical follow up
    follow up come da pratica clinica
    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 Decision2014-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-11-08
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