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    Summary
    EudraCT Number:2004-001860-27
    Sponsor's Protocol Code Number:A6181036
    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:2007-02-13
    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 number2004-001860-27
    A.3Full title of the trial
    A Treatment Protocol for Patients with Gastrointestinal Stromal Tumor who are Ineligible for Participation in Other SU011248 Protocols AND are Refractory to or Intolerant of Imatinib Mesylate.
    A Treatment Protocol for Patients with Gastrointestinal Stromal Tumor who are Ineligible for Participation in Other SU011248 Protocols AND are Refractory to or Intolerant of Imatinib Mesylate.
    A.4.1Sponsor's protocol code numberA6181036
    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 SponsorPFIZER
    B.1.3.4CountryItaly
    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 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 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 nameNA
    D.3.2Product code SU011248
    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 INNANTINEOPLASTIC AGENTS
    D.3.9.2Current sponsor codeSU011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number50
    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 typeNon Applicabile
    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
    Gastro-intestinal Stromal Tumors
    Tumore stromale gastrointestinale (GIST)
    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 10051066
    E.1.2Term Gastrointestinal stromal tumour
    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
    THE PRIMARY OBJECTIVE IS TO PROVIDE ACCESS TO SU011248 TREATMENT FOR PATIENTS WITH GIST GIVEN THE FOLLOWING CONDITIONS: - PATIENTS HAVE RECEIVED TREATMENT WITH IMATINIB MESYLATE AND HAVE DEVELOPED RESISTATNS OR INTOLLERANCE, AND -PATIENTS HAVE, IN THE JUDGMENT OF THE PI, THE POTENTIAL TO DERIVE CLINICAL BENEFIT FROM TREATMENT WITH SU011248, AND - PATIENTS ARE INELIGIBLE FOR PARTECIPATING IN ONGOING SU011248 CLINICAL STUDIES (IF ANY PHASE 1,2 OR 3 SU011248 PROTOCOLS FOR PATIENTS HAVING GIST ARE OPEN TO ENROLLMENT AT THE INSTITUTION)
    Finalita': La finalita' primaria e' di fornire l'accesso al trattamento con SU011248 per i pazienti affetti da tumore stromale gastrointestinale (GIST), date le seguenti condizioni: a) i pazienti sottoposti a screening, ma che non solo eleggibili per la partecipazione agli studi clinici in corso con SU011248 (come A6181004), e b) i pazienti che hanno ricevuto il trattamento con imatinib mesilato e hanno sviluppato resistenza o intolleranza, e c) i pazienti che, a parere dello sperimentatore, possono potenzialmente trarre beneficio clinico dal trattamento con SU011248.
    E.2.2Secondary objectives of the trial
    • Safety profile of SU011248; • Overall Survival (OS); • Time-to-progression (TTP); • Objective Response Rate (ORR).
    Le seguenti clinical endpoints saranno valutati: Profilo di sicurezza di SU011248 Sopravvivenza complessiva (OS) Tempo alla progressione (TTP) Tasso obiettivo di risposta (ORR)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Histopathologically proven diagnosis of malignant GIST that is not amenable to standard therapy with curative intent. 2. Must be ineligible for participation in ongoing SU011248 clinical studies (if any Phase 1, 2 or 3 SU011248 protocols for patients having GIST are open to enrollment at the institution). If there are no SU011248 protocols open at the institution, patients may be entered if meeting the study entry criteria. 3. Judged to have the potential to derive clinical benefit from SU011248 treatment by the treating physician. 4. Failed prior treatment with imatinib mesylate, defined either by progression of disease, or by significant toxicity during treatment with imatinib mesylate that precluded further treatment. Intolerance to prior imatinib mesylate therapy will be defined as follows: • Life-threatening adverse events (ie, Grade 4 according to NCI CTCAE Version 3.0) at any dose (attempt to dose reduce or rechallenge not required) or; • Unacceptable toxicity induced by a moderate dose (eg, 400 mg/day). Specifically, &#8805;Grade 2 toxicity that is unacceptable to the patient (such as nausea) that persists despite standard countermeasures. 5. Administration of the last dose of imatinib mesylate &#8805;1-week prior to start of treatment. 6. Male or female, 18 years of age or older. 7. Resolution of all acute toxic effects of prior systemic therapy (including imatinib mesylate), radiotherapy or surgical procedure to NCI CTCAE Version 3.0 Grade &#8804;1. 8. Adequate organ function as defined by the following criteria: • Total serum bilirubin &#8804;2 x ULN (patients with Gilbert's disease exempt); • Serum transaminases <5 x ULN; • Absolute neutrophil count (ANC) &#8805;1000/&#956;L; • Platelets &#8805;75,000/&#956;L; • Hemoglobin &#8805;8.0 g/dL (may be supported with transfusion and/or growth factors). 9. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. 10. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.
    I pazienti devono soddisfare tutti i seguenti criteri di inclusione per essere eleggibili per l'arruolamento nello studio clinico: 1. Diagnosi dimostrata istopatologicamente di tumore stromale gastrointestinale (GIST) maligno che non e` idoneo per la terapia standard con intento curativo. 2. Non devono essere eleggibili per la partecipazione agli studi clinici in corso su SU011248 (se presso l'istituzione sono aperti per l'arruolamento protocolli SU011248 di Fase 1, 2 o 3 per pazienti con tumore stromale gastrointestinale (GIST)). Se non sono aperti protocolli SU011248 presso l'istituzione, i pazienti possono essere inclusi se soddisfano i criteri di inclusione nello studio. 3. Ritenuti dal medico curante potenzialmente in grado di trarre beneficio clinico dal trattamento con SU011248 4. E` fallito il loro trattamento precedente con imatinib mesilato, definito o dalla progressione di malattia, o dalla tossicita` significativa durante il trattamento con imatinib mesilato che ha precluso l'ulteriore trattamento. L'intolleranza alla terapia precedente con imatinib mesilato sara` definita nel modo seguente: • Eventi avversi che mettono in pericolo la vita (cioe` di Grado 4 secondo i Criteri comuni di tossicita` dell'Istituto Nazionale del Cancro statunitense, NCI CTCAE, Versione 3.0) a qualsiasi dose (tentativo di ridurre la dose o di risomministrazione non richiesto) o; • Tossicita` inaccettabile indotta da una dose moderata (ad es. 400 mg/giorno). Nello specifico, tossicita` &#8805; Grado 2 che e` inaccettabile per il paziente (come nausea) che persiste nonostante le contromisure standard. 5. Somministrazione dell'ultima dose di imatinib mesilato &#8805;1 settimana prima dell'inizio del trattamento. 6. Maschi o femmine, di eta` a partire dai 18 anni. 7. Risoluzione di tutti gli effetti tossici acuti della terapia sistemica (incluso imatinib mesilato), della radioterapia o dell'intervento chirurgico precedente al Grado &#8804;1 secondo i Criteri comuni di tossicita` dell'Istituto Nazionale del Cancro statunitense, NCI CTCAE, Versione 3.0. 8. Funzione organica adeguata definita dai seguenti criteri: • Bilirubina sierica totale &#8804;2 x il limite superiore del normale (LSN) (eccetto pazienti con sindrome di Gilbert); • Transaminasi sieriche &lt;5 x il limite superiore del normale (LSN); • Conta assoluta dei neutrofili (ANC) &#8805;1000/&#956;L; • Piastrine &#8805;75.000/&#956;L; • Emoglobina &#8805;8,0 g/dL (puo` essere supportato con trasfusione e/o fattori di crescita). 9. Documento di consenso informato firmato e datato indicante che il paziente (o il rappresentante legalmente autorizzato) e` stato informato su tutti gli aspetti pertinenti dello studio prima dell'arruolamento. 10. Disponibilita` e abilita` di attenersi alle visite programmate, ai piani terapeutici, agli esami di laboratorio ed alle altre procedure dello studio.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial: 1. Current treatment in another therapeutic clinical trial; 2. Symptomatic CNS metastases; 3. Symptomatic congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina or any unstable arrhythmia requiring medication; 4. Pregnancy or breastfeeding (See Section 4.4 for further details); 5. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    Non saranno inclusi nello studio i soggetti che presentano uno qualsiasi dei seguenti: 1. Trattamento in atto in un altro studio clinico terapeutico; 2. Metastasi sintomatiche del sistema nervosa centrale (SNC); 3. Insufficienza cardiaca congestizia sintomatica, infarto miocardico o impianto di bypass arterioso coronarico nei sei mesi precedenti, angina grave o instabile in corso o qualsiasi aritmia instabile che richiede il trattamento farmacologico; 4. Gravidanza o allattamento 5. Altra condizione medica o psichiatrica acuta o cronica severa, o anormalita` di laboratorio che creerebbe, a giudizio dello Sperimentatore, un rischio eccessivo associato alla partecipazione allo studio o alla somministrazione del farmaco in studio, o che, a giudizio dello Sperimentatore, renderebbe il paziente inappropriato per l'inclusione in questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to provide access to SU011248 treatment for patients with GIST according to conditions described in the protocol without formal hypothesis testing. In addition, the following clinical endpoints will be evaluated. • Safety profile of SU011248; • Overall Survival (OS); • Time-to-progression (TTP); • Objective Response Rate (ORR).
    La finalita' primaria e' di fornire l'accesso al trattamento con SU011248 per i pazienti affetti da tumore stromale gastrointestinale (GIST) secondo le condizioni descritte nel protocollo senza processo di controllo delle ipotesi formale. Saranno inoltre valutati i seguenti endpoint clinici. Profilo di sicurezza di SU011248 Sopravvivenza complessiva (OS) Tempo alla progressione (TTP) Tasso obiettivo di risposta (ORR)
    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 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 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 trial0
    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 concerned8
    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 Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state79
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 401
    F.4.2.2In the whole clinical trial 1098
    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 Decision2005-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-05-11
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