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    Summary
    EudraCT Number:2011-005836-25
    Sponsor's Protocol Code Number:BAY73-4506/15967
    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:2012-04-03
    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 number2011-005836-25
    A.3Full title of the trial
    An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy
    Studio di fase IIIb in aperto sull'uso di regorafenib in pazienti con cancro colonrettale (CRC) metastatico, in progressione dopo la terapia standard
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Regorafenib given to patients with metastatic colorectal cancer (CRC) who have failed all available standard therapy
    Regorafenib in pazienti con cancro colonrettale (CRC) metastatico, in progressione dopo la terapia standard
    A.4.1Sponsor's protocol code numberBAY73-4506/15967
    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 SponsorBAYER HEALTHCARE AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical trails Contact
    B.5.3 Address:
    B.5.3.1Street AddressCPT Team / Ref: ''EU CTR''/Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number.
    B.5.5Fax number.
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 nameRegorafenib
    D.3.2Product code Bay 73-4506
    D.3.4Pharmaceutical form Film-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.3.9.1CAS number 755037-03-7
    D.3.9.2Current sponsor codeBay 73-4506
    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
    Colorectal neoplasms
    cancro colonrettale
    E.1.1.1Medical condition in easily understood language
    Metastatic adenocarcinoma of the colon or rectum (metastatic CRC)
    adenocarcinoma del colon o del retto 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 10052362
    E.1.2Term Metastatic colorectal 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 provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed all approved standard therapies - to assess the safety of regorafenib
    - Somministrare regorafenib a pazienti con diagnosi di cancro colonrettale metastatico dopo il fallimento di tutte le terapie standard approvate - Valutare la sicurezza del regorafenib
    E.2.2Secondary objectives of the trial
    to assess progression free survival (PFS)
    - Valutare la sopravvivenza senza progressione della malattia (PFS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female subjects ≥ 18 years of age. •Life expectancy of at least 3 months •Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded. •Subjects with metastatic colorectal cancer (Stage IV). •Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan,bevacizumab and cetuximab/panitumumab (if KRAS WT) (WT: wild type) •ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group) •Adequate bone marrow, liver and renal function •Women of childbearing potential and men must agree to use adequate contraception
    - Pazienti di sesso maschile o femminile con età maggiore/uguale 18 anni - Aspettativa di vita di almeno 3 mesi - Documentazione istologica o citologica di adenocarcinoma del colon o del retto, con esclusione di tutti gli altri tipi istologici - Pazienti con cancro colonrettale metastatico (stadio IV) - Progressione durante o nei 3 mesi successivi all’ultima somministrazione delle terapie standard approvate, che devono includere fluoropirimidina, oxaliplatino, irinotecan, bevacizumab e cetuximab o panitumumab (se KRAS WT) (WT: tipo non mutato). - Stato di validità ECOG minore/uguale 1 (ECOG: Eastern Cooperative Oncology Group) - Funzionalità midollare ossea, epatica e renale adeguata - Sia le donne in età fertile sia gli uomini devono accettare di utilizzare un sistema contraccettivo adeguato.
    E.4Principal exclusion criteria
    - Prior treatment with regorafenib. - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication treatment - Pregnant or breast-feeding subjects. - Congestive heart failure ≥ New York Heart Association (NYHA) class 2. - 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. - Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). - Uncontrolled hypertension. (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management). - Pleural effusion or ascites that causes respiratory compromise (≥ CTCAE Grade 2 dyspnea). (CTCAE: common terminology criteria for adverse events) - Ongoing infection > Grade 2 CTCAE v. 4.0. - Known history of human immunodeficiency virus (HIV) infection. - Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy. -Subjects with seizure disorder requiring medication. - Subjects with evidence or history of any bleeding diathesis, irrespective of severity. - Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of study medication. - Non-healing wound, ulcer, or bone fracture. - Renal failure requiring hemo-or peritoneal dialysis. - Dehydration CTCAE v. 4.0 Grade ≥ 1. - Interstitial lung disease with ongoing signs and symptoms - Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours). - Any malabsorption condition. - Unresolved toxicity higher than CTCAE (v. 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity ≤ Grade 2. - Concomitant participation or participation within the last 30 days in another clinical trial - 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.
    - Trattamento precedente con regorafenib - Procedura chirurgica maggiore, biopsia aperta o lesione traumatica importante nei 28 giorni precedenti l’inizio del trattamento sperimentale - Pazienti in gravidanza o allattamento - Insufficienza cardiaca congestizia maggiore/uguale New York Heart Association (NYHA) classe 2 - Angina instabile (sintomi a riposo), angina di nuova insorgenza (iniziata negli ultimi 3 mesi) - Infarto miocardico meno di 6 mesi prima dell’inizio del trattamento sperimentale - Aritmie cardiache che richiedono la somministrazione di terapia antiaritmica (sono consentiti i beta bloccanti o la digossina) - Ipertensione non controllata (pressione sistolica &gt; 140 mmHg o pressione diastolica &gt; 90 mmHg nonostante il trattamento medico ottimale) - Versamento pleurico o ascite con conseguente compromissione respiratoria (dispnea maggiore/uguale grado 2 CTCAE ) (CTCAE: criteri comuni di terminologia per gli eventi avversi) - Infezione in corso &gt; grado 2 CTCAE versione 4.0 - Anamnesi nota di infezione da virus dell’immunodeficienza umana (HIV) - Epatite B o C attiva o epatite B o C cronica, comportante la necessità di una terapia antivirale - Pazienti con disturbi convulsivi che richiedono una terapia farmacologica - Pazienti con evidenza o anamnesi di diatesi emorragica, indipendentemente dalla gravità - Qualsiasi emorragia o sanguinamento maggiore/uguale grado 3 CTCAE entro le 4 settimane precedenti l’inizio del trattamento sperimentale - Ferita, ulcera o frattura ossea non in guarigione - Insufficienza renale che richiede emodialisi o dialisi peritoneale - Disidratazione maggiore/uguale grado 1 CTCAE versione 4.0 - Malattia polmonare interstiziale con segni e sintomi presenti al momento della firma del consenso informato - Proteinuria persistente di grado 3 CTCAE (&gt; 3,5 g/24 ore) - Qualsiasi condizione di malassorbimento - Tossicità non risolta superiore al grado 1 CTCAE (versione 4.0), attribuita a una terapia/procedura precedente, esclusi alopecia, ipotiroidismo e neurotossicità indotta da oxaliplatino minore/uguale grado 2 - Partecipazione concomitante o partecipazione negli ultimi 30 giorni a un’altra sperimentazione clinica - Terapia antitumorale sistemica, comprese terapia citotossica, terapia con inibitori della trasduzione del segnale, immunoterapia e terapia ormonale nel corso di questa sperimentazione o nelle 4 settimane (o 6 settimane per la mitomicina C) precedenti l’inizio della somministrazione del trattamento sperimentale.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be safety Safety Analysis Set (SAF) : the population for the safety analyses is the SAF. All subjects who received at least one dose of regorafenib belong to the SAF. •Descriptive summary tables will be presented on all safety parameters. •Subjects will be monitored for adverse events using the NCI-CTCAE version 4.0. (NCI: National Cancer Institute) •Treatment emergent adverse events and safety laboratory parameters will be summarized by NCI-CTCAE version 4.0 grade and by MedDRA terminology. A treatment-emergent AE is defined as any event arising or worsening after the start of study drug administration until 30 days after the last study medication. •AEs that caused subject withdrawal, dose reduction, or interruption will be summarized. •Patients who die during the study will be summarized and listed. •Patients with SAEs will be summarized and listed. •Adverse events leading to discontinuation will be summarized and listed.
    L’endpoint primario sarà rappresentato dalla sicurezza. Safety Analysis Set (SAF): la popolazione per le analisi di sicurezza è il SAF. Tutti i soggetti che riceveranno almeno una dose di regorafenib appartengono al SAF. - Per tutti i parametri di sicurezza saranno presentate delle tabelle riepilogative descrittive - I pazienti saranno tenuti sotto controllo per gli eventi avversi usando i criteri NCI-CTCAE versione 4.0 (NCI: National Cancer Institute). - Gli eventi avversi dovuti al trattamento e i parametri di laboratorio valutabili per la sicurezza saranno riepilogati per grado NCI-CTCAE versione 4.0 e per terminologia MedDRA. Per evento avverso dovuto al trattamento si intende qualsiasi evento che insorga o peggiori dopo l’inizio del trattamento sperimentale e fino ai 30 giorni successivi alla somministrazione dell’ultima dose. - Saranno riepilogati gli eventi avversi che hanno determinato il ritiro dei pazienti dallo studio, la riduzione del dosaggio o l’interruzione del trattamento sperimentale. - Saranno riepilogati ed elencati i decessi che si verificano nel corso dello studio. - Saranno riepilogati ed elencati i pazienti che manifestano eventi avversi gravi. - Saranno riepilogati ed elencati gli eventi avversi che comportano la sospensione del trattamento sperimentale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last patient last visist date (no event-driven primary completion date)
    Last patient last visist date (no event-driven primary completion date)
    E.5.2Secondary end point(s)
    PFS is the only efficacy variable to be analyzed in this study The population for the efficacy analysis is the FAS (Full Analysis Set). All subjects assigned to treatment belong to the FAS. • The Kaplan-Meier curve for PFS and the • Kaplan-Meier estimate of median time to PFS with its confidence interval (CI) • PFS proportions at 3, 6, 9, 12, etc months with CIs
    PFS nel presente studio rappresenta la sola variabile utilizzabile ai fini della valutazione dell’efficacia. La popolazione per le analisi di efficacia è il FAS (Full Analysis Set). Tutti i soggetti assegnati al trattamento appartengono al FAS. - Curva di Kaplan-Meier per la PFS e - stima di Kaplan-Meier per il tempo mediano alla PFS con relativo intervallo di confidenza (IC) - Percentuali di PFS a 3, 6, 9, 12, etc. mesi con IC
    E.5.2.1Timepoint(s) of evaluation of this end point
    Last patient last visist date ( no event-driven primary completion date)
    Last patient last visist date ( no event-driven primary completion date)
    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) 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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA97
    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
    Australia
    Canada
    Switzerland
    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
    LVLS Primary Completion is the same as LPLV, no early end point
    LVLS Primary Completion is the same as LPLV, no early end point
    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 months26
    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 months26
    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: 1650
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1350
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1920
    F.4.2.2In the whole clinical trial 3000
    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)
    NA
    NA
    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 Opinion2012-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
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