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    Summary
    EudraCT Number:2008-007152-94
    Sponsor's Protocol Code Number:02-2008
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-01-13
    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 number2008-007152-94
    A.3Full title of the trial
    Efficacy and Safety of RAD001 (Everolimus) in Patients Affected by Biliary Tract Cancer Progressing After Prior Chemotherapy: a Phase II I.T.M.O. Study
    A.3.2Name or abbreviated title of the trial where available
    Everolimus in biliary tract cancer
    A.4.1Sponsor's protocol code number02-2008
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorI.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY
    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 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 nameEVEROLIMUS
    D.3.2Product code RAD001
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEverolimus
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeDERIVATO DI MACROLIDE
    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
    Patients affected by biliary tract cancer progressing after prior chemotherapy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10055111
    E.1.2Term Biliary cancer metastatic
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the disease control rate (DCR) and objective response rate (ORR) as a measure of the antitumor effect of RAD001
    E.2.2Secondary objectives of the trial
    To assess DCR and ORR as a measure of the antitumor effect of RAD001, according to mTOR expression in tumor cells as optional biomarker study. To assess progression-free survival (PFS) and overall survival (OS) among all patients on RAD001, and according to mTOR expression as optional biomarker study. To describe the safety profile of RAD001
    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 biologico indirizzato ai fattori predittivi di risposta
    E.3Principal inclusion criteria
    - Histologically or cytologically proven diagnosis of biliary tract carcinomas (BTC) - Locally advanced, metastatic, or recurrent biliary tract cancer who had received not more than one previous chemotherapy regimen for their metastatic disease. If adjuvant chemotherapy and/or radiotherapy has been done, it is not considered as one line - Not indication to surgery or radiotherapy for locally advanced disease - At least one measurable site of disease according to RECIST criteria - Age > 18 and < 75 years - PS 0-2 (ECOG) - Life expectancy >= 12 weeks Neutrophyls count >= 2 x 109 /L and platelets count >=100 x 109/L. - Total bilirubin <= 1.5 time the upper-normal limits (UNL) of the Institutional normal values and ASAT (SGOT) and or ALAT (SGPT) <= 2 x UNL (<= five times the UNL for patients with liver metastasis), alkaline phosphatase <= 2.5 x UNL (unless bone metastasis are present in the absence of any liver disorders) - Creatinine < 140 mmol/L (1.6 mg/dL); if limit values, the creatinine clearance should be performed and should be >= 60 ml / min. - No previous chemotherapy, radiation therapy or major surgical procedures within 4 weeks before study entry - Written informed consent - Patients must be accessible for treatment and follow up. Patients registered in this trial must be treated and followed at the participating centers
    E.4Principal exclusion criteria
    - Patients who received VEGFi therapy within 4 weeks prior to study entry - Patients who received prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus) - Patients with known hypersensitivity to RAD001(everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients - Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent. Inhaled and topical steroids are acceptable - Patients with a known history of HIV seropositivity - Patients with autoimmune hepatitis - Patients with an active, bleeding diathesis. Patients may use coumadin or heparin preparations - Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: - Congestive hearth failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia - History of significant neurological or psychiatric disorders including dementia or seizures - Active infections - Past or current history of neoplasm other than curatively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix - Presence of metastatic CNS involvement - Patients that are currently, or in the 30 days prior to study screening, receiving other investigational agents - Patients with malabsorption syndrome or any other disorder that would affect gastrointestinal absorption - Patients unwilling or unable to comply with the requisites of the protocol - Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Oral contraceptives are not acceptable
    E.5 End points
    E.5.1Primary end point(s)
    Disease control rate (DCR), defined as the proportion of patients with CR (complete response), PR (partial response) or SD (stable disease) as overall objective response at the tumor assessment performed at 8 weeks, according to RECIST criteria. The denominator is the number of evaluable patients, defined as treated patients with an overall objective response at week 8 other than Unknown, or with progression or death from progressive disease before week 8. Objective response rate (ORR), defined as the proportion of patients with a best overall response of CR or PR, as per RECIST criteria. ORR will be estimated in the intention to treat (ITT) population, defined as all patients who received at least one dose of RAD001
    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 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 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.8.3 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 concerned14
    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 Information not present in EudraCT
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 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 state37
    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 Decision2009-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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