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    Summary
    EudraCT Number:2014-001093-34
    Sponsor's Protocol Code Number:ONC-2014-001
    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:2014-09-29
    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 number2014-001093-34
    A.3Full title of the trial
    An Open-Label Phase II Study of regorafenib In Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy - RESOUND
    Studio di fase II in aperto sull’uso di regorafenib in pazienti con neoplasie solide metastatiche, in progressione dopo la terapia standard - RESOUND
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Phase II Study of regorafenib In Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy - RESOUND
    Studio di fase II in aperto sull’uso di regorafenib in pazienti con neoplasie solide metastatiche, in progressione dopo la terapia standard - RESOUND
    A.3.2Name or abbreviated title of the trial where available
    Resound
    Resound
    A.4.1Sponsor's protocol code numberONC-2014-001
    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 SponsorIstituto Clinico Humanitas
    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 supportIstituto Clinico Humanitas
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEMMEDI Srl Divisione Solaris
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressVia C. Poma 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20129
    B.5.3.4CountryItaly
    B.5.4Telephone number00390276114280
    B.5.5Fax number00390276118026
    B.5.6E-mailsolaris@solariscro.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 Yes
    D.2.1.1.1Trade name Stivarga 40 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer
    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 nameStivarga
    D.3.2Product code Bay 73-4506
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNregorafenib
    D.3.9.1CAS number 755037-03-7
    D.3.9.3Other descriptive nameREGORAFENIB
    D.3.9.4EV Substance CodeSUB73090
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Metastatic Solid Tumors
    Tumori solidi metastatici
    E.1.1.1Medical condition in easily understood language
    Metastatic Solid Tumors
    Tumori Solidi Metastatici
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    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
    Estimate Progression -free survival (PFS) from disease
    Stimare la sopravvivenza senza progressione della malattia (PFS)
    E.2.2Secondary objectives of the trial
    Estimate overall Survival (OS)
    Estimate Rate of Tumor response (ORR)
    Evaluate Regorafenib Safety
    Stimare la sopravvivenza globale (OS)
    Stimare il tasso di risposta tumorale (ORR)
    Valutare la sicurezza del regorafenib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent
    2. Patients 1. Signed informed consent
    2. Patients ≥ 18 years.
    3. Locally advanced, recurrent or metastatic histologically confirmed malignancy refractory to available standard treatment, included in the list below
    - Pancreatic cancer
    - Ovarian cancer
    - Melanoma
    - Sarcoma (angiosarcoma, leiomyosarcoma e sinovial sarcoma)
    4. At least one measurable lesion according to Response Evaluation Criteria In Solid Tumor (RECIST criteria, Version 1.1) (see Appendix C). Lesions must be measured by CT-scan or MRI
    5. ECOG Performance Status: 0-1
    6. Life expectancy of at least 12 weeks
    7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
    - Hemoglobin >9.0 g/dl
    - Absolute neutrophil count (ANC) >1,500/mm3
    - Platelet count ≥ 100,000/μl
    - WBC >3.0 x 109/L
    - Total bilirubin <1.5 times the upper limit of normal
    - ALT and AST <2.5 x upper limit of normal (<5 x upper limit of normal for patients with liver involvement of their cancer and/or have bone metastasis)
    -Serum creatinine <1.5 x upper limit of normal
    - Alkaline phosphatase <2.5 x ULN ((<5 x upper limit of normal for patients with liver involvement of their cancer and/or have bone metastasis)
    - 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).
    - Lipase ≤ 1.5 x the ULN
    8. Able to swallow and retain oral medication.
    9. Estimated creatinine clearance (CLcr) > 30ml/min as calculated using the Crockcroft-Gault equation
    10. Resolution of any toxic effects of prior therapy to NCI CTCAE, Version 4.0, grade ≤ 1 (with the exception of alopecia and grade ≤ 2 neuropathy) .
    11. Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug admnistration. The investigator or a designated associate is requested to advise the subject on how to achieve an adequate birth control. Adequate contraceptions is definde in the study as medically recommended method ( or combination of methods) as per standard care.18 years.
    1. Consenso informato firmato ottenuto prima dell’esecuzione di qualsiasi procedura specifica per lo studio. I soggetti devono essere in grado di comprendere e devono accettare di firmare un consenso informato scritto.
    2. Soggetti di sesso maschile o femminile ≥18 anni d’età.
    3. Diagnosi confermata istologicamente di tumore solido (compreso nell’elenco sottostante) in fase avanzata per la quale non esiste un trattamento alternativo standard:
    - Carcinoma pancreatico
    - Carcinoma ovarico
    - Melanoma maligno
    - Sarcomi dei tessuti molli (angiosarcoma, leiosarcoma sarcoma sinoviale)
    4. I soggetti devono avere almeno una lesione misurabile in base ai RECIST, versione 1.1. Una lesione in un’area precedentemente irradiata è eleggibile per essere considerata una malattia misurabile, purché esista un’evidenza oggettiva di progressione della lesione prima del reclutamento nello studio.
    5. Eastern Cooperative Oncology Group (ECOG) Performance Status pari a 0 o 1.
    6. Aspettativa di vita di almeno 12 settimane
    7. Funzionalità midollare, epatica e renale adeguata determinata in base alle seguenti valutazioni di laboratorio eseguite entro 7 giorni dall’inizio del trattamento in studio:
    - Conta delle piastrine ≥ 100000/mm3, emoglobina (Hb) ≥ 9,0 g/dl, conta assoluta dei neutrofili (ANC) ≥ 1500/mm3. Non saranno consentite trasfusioni per permettere ai soggetti di soddisfare i criteri di inclusione.
    - Bilirubina totale ≤ 1,5 x limite superiore del normale (ULN).
    - Alanina aminotransferasi (ALT) e aspartato aminotransferasi (AST) ≤ 2,5 x ULN (≤ 5 x ULN per i soggetti con coinvolgimento epatico).
    - Creatinina sierica ≤ 1,5 x ULN.
    - Limite di fosfatasi alcalina ≤ 2,5 x ULN (≤ 5 x ULN per i soggetti con coinvolgimento epatico o osseo del carcinoma).
    - Rapporto internazionale normalizzato (INR) ≤ 1.5 x ULN e tempo parziale di tromboplastina ( PTT) o tempo di tromboplastina parziale attivata ≤ 1.5 x ULN. I soggetti trattati con qualche anticoagulante, come warfarin o eparina, potranno partecipare purché non esista nessuna evidenza precedente di un’anomalia latente in tali parametri. Sarà eseguito uno stretto monitoraggio almeno delle valutazioni settimanali fino a quando INR e PTT saranno stabili in base a una misurazione pre-dose come definito dallo standard locale di assistenza.
    - Lipasi ≤ 1,5 x the ULN
    8. Capacità di ingerire farmaci orali.
    9. Stima di Clearance Creatinina (CLCr) ≥ 30 ml/min in base alla formula di Crockcroft-Gault.
    10. Ritorno a un livello NCI-CTCAE v4.0 Grado 0 o 1, o ritorno al basale pre-trattamento di qualsiasi tossicità correlata a farmaci/procedure precedenti (fatta eccezione per alopecia, anemia e ipotiroidismo).
    11. Le donne e gli uomini potenzialmente fertili e in grado di procreare devono accettare di utilizzare metodi contraccettivi adeguati (metodi barriera per il controllo delle nascite) al momento della firma del consenso informato e
    fino ad almeno 3 mesi dopo l’ultima somministrazione del farmaco in studio. La definizione dei metodi contraccettivi adeguati sarà basata sul giudizio dello sperimentatore curante o di un associato incaricato.
    E.4Principal exclusion criteria
    1. Prior treatment with regorafenib.
    2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
    3. Congestive heart failure >New York Heart Association (NYHA) class 2
    4. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months).Myocardial infarction less than 6 months before start of study drug
    5. Myocardial infarction less than 6 months before start of study drug.
    6. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
    7. Uncontrolled hypertension. (Systolic blood pressure >150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
    8. Pleural effusion or ascites that causes respiratory compromise (>CTCAE Grade 2 dyspnea).
    9. Ongoing infection > Grade 2 CTCAE v. 4.0.
    10. Known history of human immunodeficiency virus (HIV) infection.
    11. Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
    12. Subjects with seizure disorder requiring medication.
    13. History of organ allograft. Subjects with evidence orzhistory of any bleeding diathesis, irrespective of severity.
    14. Any hemorrhage or bleeding event >CTCAE Grade 3 within 4 weeks prior to the start of study medication.
    15. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication (except for adequately treated catheter-related venous thrombosis occuring more than one months before the start of study medication)
    16. Known history or symptomatic metastatic brain or meningeal
    tumors (head CT or MRI at screening to confirm the absence of
    central nervous system [CNS] disease if patient has symptoms
    17. Suggestive or consistent with CNS disease)Non-healing wound, ulcer, or bone fracture.
    18. Renal failure requiring hemo-or peritoneal dialysis.
    19. Dehydration CTCAE v. 4.0 Grade >1.
    20. Substance abuse, medical, psychological or social conditions that may interfere with the subject‟s participation in the study or evaluation of the study results.
    21. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
    22. Any illness or medical conditions that are unstable or could jeopardize the safety of the subject and his/her compliance in the study.
    23. Interstitial lung disease with ongoing signs and symptoms
    24. Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours).
    25. Any malabsorption condition.
    26. Concomitant participation or participation within the last 30 days in another clinical trial
    27. Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks (or within 6 weeks for mitomycin C) before starting to receive study medication.
    1. Trattamento precedente con regorafenib. I soggetti ritirati in modo permanente dalla partecipazione allo studio non potranno accedere nuovamente alla ricerca.
    2. Intervento chirurgico maggiore, biopsia aperta o lesione traumatica significativa entro 28 giorni prima dell’inizio della somministrazione del farmaco in studio.
    3. Insufficienza cardiaca congestizia New York Heart Association (NYHA) ≥ classe 2.
    4. Angina instabile (sintomi di angina a riposo, angina di nuova insorgenza, ovvero, entro gli ultimi 3 mesi)
    5. Infarto miocardico (MI) negli ultimi 6 mesi prima dell’inizio del farmaco in studio.
    6. Aritmie cardiache che necessitano di una terapia antiaritmica (sono consentiti beta bloccanti o digossina).
    7. Ipertensione incontrollata (pressione sanguigna sistolica > 140 mmHg o pressione diastolica > 90 mmHg nonostante una gestione medica ottimale).
    8. Soggetti con e ffusione pleurica o ascite che determina una compromissione respiratoria (≥ NCI-CTCAE version 4.0 dispnea CTC Grado 2).
    9. Infezione in corso > grado 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) versione 4.0.
    10. Storia nota di infezione da virus dell’immunodeficienza umana (HIV).
    11. Epatite B o C attiva oppure epatite B o C cronica in trattamento antivirale.
    12. Soggetti con disordine epilettico che necessitano di trattamento.
    13. Storia di trapianto allogenico d’organo. Eventi arteriosi trombotici o embolici come accidenti cerebrovascolari (inclusi attacchi ischemici transitori), o embolismo polmonare entro i 6 mesi prima dell’inizio del farmaco in studio.
    14. Soggetti con evidenza o storia di diatesi emorragica. Qualsiasi evento emorragico o di sanguinamento  NCI-CTCAE versione 4.0 grado 3 o superiore entro 4 settimane prima dell’inizio della somministrazione del farmaco in studio.
    15. Eventi venosi trombotici, quali trombosi venosa profonda, entro i 3 mesi prima dell’inizio della somministrazione del farmaco in studio
    16. Tumori sintomatici metastatici cerebrali, o meningei
    17. Ferite, ulcere o fratture ossee che non guariscono.
    18. Insufficienza renale che necessita di emodialisi o dialisi peritoneale.
    19. Disidratazione NCI-CTCAE versione 4.0 di grado ≥ 1.
    20. Abuso di sostanze o condizioni mediche, psicologiche o sociali che potrebbero interferire con la partecipazione del soggetto allo studio o con la valutazione dei risultati della ricerca.
    21. Ipersensibilità nota al farmaco in studio, alla classe del farmaco in studio o a eccipienti nella formulazione.
    22. Qualsiasi malattia, o condizione medica instabile, o che potrebbe mettere a rischio la sicurezza del soggetto e la sua compliance allo studio.
    23. Malattia polmonare interstiziale con segni e sintomi in atto al momento dello screening.
    24. Proteinuria persistente NCI-CTCAE versione 4.0 di grado 3 o superiore (> 3,5 g/24 ore, misurata in base alla proporzione urinaria proteina:creatinina su un campione casuale di urina).
    25. Qualsiasi condizione di malassorbimento.
    26. Partecipazione concomitante a un altro studio clinico.
    27. Trattamento con altre terapie sistemiche antitumorali incluse terapie citotossiche, inibitori del segnale di trasduzione, immunoterapie e terapie ormonali nel corso dello studio o nelle 4 settimane precedent all’ingresso in studio (6 settimane se il precedente trattamento comprendeva Mitomicina C)
    E.5 End points
    E.5.1Primary end point(s)
    2 Month PFS rate
    Tasso di PFS a due mesi
    E.5.1.1Timepoint(s) of evaluation of this end point
    October 2018
    ottobre 2018
    E.5.2Secondary end point(s)
    Estimate overall Survival (OS)
    Estimate Rate of Tumor response (ORR)
    Evaluate Regorafenib Safety
    Stimare la sopravvivenza globale (OS)
    Stimare il tasso di risposta tumorale (ORR)
    Valutare la sicurezza del regorafenib
    E.5.2.1Timepoint(s) of evaluation of this end point
    May 2019
    maggio 2019
    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.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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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 years4
    E.8.9.1In the Member State concerned months7
    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: 80
    F.1.3Elderly (>=65 years) No
    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 state80
    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)
    Treated until disease progression
    Trattamento fino a progressione della malattia
    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 Decision2014-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-23
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