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    Summary
    EudraCT Number:2008-006544-20
    Sponsor's Protocol Code Number:CRAD001R2301
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-29
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-006544-20
    A.3Full title of the trial
    A randomized, double-blind, multi-center phase III study comparing everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in patients with advanced gastric cancer after progression on prior systemic chemotherapy
    A.4.1Sponsor's protocol code numberCRAD001R2301
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 Yes
    D.2.1.1.1Trade name Afinitor
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRAD001 5mg Tablets (elongated)
    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.3.9.1CAS number 159351-69-6
    D.3.9.2Current sponsor codeRAD001
    D.3.9.3Other descriptive name4"-O-(2-hydroxyethyl)-rapamycin
    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 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) 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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    advanced gastric cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare overall survival between RAD001+best supportive care (BSC) and placebo+BSC in patients with advanced gastric cancer after progression on prior systemic chemotherapy.
    E.2.2Secondary objectives of the trial
    • To compare progression free survival between RAD001+BSC and placebo+BSC.
    • To compare quality of life between RAD001+BSC and placebo+BSC.
    • To compare time to deterioration of ECOG Performance Status between RAD001+BSC and placebo+BSC
    • In the RAD001+BSC arm, to evaluate the overall response rate.
    • To further characterize the safety and tolerability of RAD001 in this population.
    • To compare Cmin and Cmax (maximum of C1h and C2h) between patients with and without gastrectomy
    • To compare exposure levels (Cmin and Cmax) of Asia versus Rest of World gastric cancer patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patients ≥ 18 years old
    • Histologically or cytologically confirmed and documented gastric adenocarcinoma. Patients with advanced gastro-esophageal junction adenocarcinoma, of which the majority, as assessed by the investigator, involves the stomach, will be eligible for inclusion in the study.
    • Documented progression after 1 or 2 prior systemic chemotherapy lines for advanced disease
    Note: One line of therapy in the advanced disease setting consists of one or more drugs which are given for 21 days or longer
    Note: Prior adjuvant/neoadjuvant therapy is allowed. If recurrence occurred during adjuvant/neoadjuvant therapy or ≤ 24 weeks after adjuvant/neoadjuvant therapy completion, the adjuvant/neoadjuvant therapy will be considered as one prior line of systemic chemotherapy for advanced disease
    Note: Prior treatment with chemotherapy combined with targeted agents is permitted
    • ECOG performance status of ≤ 2
    • Patients with the following laboratory parameters can be included:
    o Absolute neutrophil count ≥ 1.5 x 109/L (≥ 1500/mm3)
    o Platelets ≥ 100 x 109/L (≥ 100,000/mm3)
    o Hemoglobin (Hgb) ≥ 8 g/dL (≥ 4.9 mmol/L)
    o INR ≤ 2.0
    o Serum creatinine ≤ 2 x Upper Limit of Normal (ULN)
    o Adequate liver function as defined as:
    • If there is no evidence of liver metastasis: ALT and AST ≤ 2.5 x ULN
    • If liver metastases are documented: ALT and AST ≤ 5.0 x ULN
    o Serum bilirubin ≤ 1.5 x ULN
    o Total serum calcium (corrected for serum albumin) or ionized calcium ≥ Lower Limit of Normal (LLN)
    o Serum potassium ≥ LLN
    Note: Calcium, potassium, magnesium and phosphate supplements may be given to correct values that are below the LLN, but must be documented as corrected prior to patients enrolling on the study
    • Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of study treatments and must be willing to use adequate methods of contraception during the study and for 8 weeks after last study drug administration
    • Written informed consent
    E.4Principal exclusion criteria
    • Patients who have received > 2 prior lines of systemic therapy for advanced disease. See notes under inclusion criterion 3.
    • Administration of anti-cancer therapy within 3 weeks prior to randomization, except for fluoropyrimidine monotherapy, where randomization may occur 2 weeks after last dose.
    • Known hypersensitivity to RAD001 (everolimus) or to its excipients, or to other rapamycins (e.g., sirolimus, temsirolimus)
    • Chronic treatment with steroids (except for oral, topical or local injection) or another immunosuppressive agent
    • Major surgery ≤ 2 weeks prior to randomization
    Note: Patients must have recovered from the acute effects of surgery prior to randomization.
    • Malignant ascites requiring invasive treatment (such as ascites drainage)
    • Lack of resolution of all acute toxic effects of prior chemotherapy, prior radiotherapy, or surgical procedure according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1, with the exception of neuropathy (inclusion of patients with neuropathy of Grade 2 or less is permitted) and alopecia
    • Patients with central nervous system metastases
    • Known history of HIV seropositivity (HIV testing is not mandatory)
    • Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin and acetylsalicylic acid, as long as the INR is ≤ 2.0)
    • Any malignancy within 3 years prior to randomisation, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma
    • Any severe and/or uncontrolled medical conditions which could cause unacceptable safety risks or compromise compliance with the protocol, such as:
    o Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 24 weeks prior to enrollment, serious uncontrolled cardiac arrhythmia
    o Uncontrolled diabetes as defined by fasting serum glucose > 1.5 X ULN
    o ≥ Grade 3 hypercholesterolemia/hypertriglyceridemia or ≥ Grade 2 hypercholesterolemia/hypertriglyceridemia with history of coronary artery disease (despite lipid-lowering treatment if given)
    o Acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
    o Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs, with the exception of prior gastrectomy (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome).
    Note: Data from the phase II Japanese study of RAD001 in AGC does not suggest that gastrectomy impairs the absorption of RAD001.
    o Active skin, mucosa, ocular or GI disorders of Grade > 1
    o Chronic obstructive or chronic restrictive pulmonary disease including dyspnea at rest from any cause
    • Patients who are enterally fed (e.g. via a nasogastric or nasojejunal tube, or via a gastrostomy or jejunostomy)
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS) defined as the time from randomization to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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 months2
    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 months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Please refer to protocol chapter 11, INFORMED CONSENT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 633
    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 Decision2009-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-30
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