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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-016468-35
    Sponsor's Protocol Code Number:D8480C00067
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-02-23
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-016468-35
    A.3Full title of the trial
    A randomised, double-blind, phase III efficacy and safety study of cediranib (RECENTIN™ ) when added to cisplatin plus a fluoropyrimidine, compared with cisplatin plus a fluoropyrimidine alone, in patients with previously untreated, locally advanced or metastatic, unresectable Gastric Cancer (GC)
    A.4.1Sponsor's protocol code numberD8480C00067
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 nameRECENTIN
    D.3.2Product code AZD2171
    D.3.4Pharmaceutical form Film-coated 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 INNCEDIRANIB
    D.3.9.1CAS number 288383-20-0
    D.3.9.2Current sponsor codeAZD2171
    D.3.9.3Other descriptive nameRECENTIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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.IMP: 2
    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 nameRECENTIN
    D.3.2Product code AZD2171
    D.3.4Pharmaceutical form Film-coated 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 INNCEDIRANIB
    D.3.9.1CAS number 288383-20-0
    D.3.9.2Current sponsor codeAZD2171
    D.3.9.3Other descriptive nameRECENTIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Gastric cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10017760
    E.1.2Term Gastric cancer NOS
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10017766
    E.1.2Term Gastric cancer stage IV NOS
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10017767
    E.1.2Term Gastric cancer stage IV with metastases
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10017768
    E.1.2Term Gastric cancer stage IV without metastases
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10061967
    E.1.2Term Gastric cancer stage IV
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic 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 determine the efficacy of cediranib when added to cisplatin plus a fluoropyrimidine compared to cisplatin plus a fluoropyrimidine alone by assessment of overall survival (OS).
    E.2.2Secondary objectives of the trial
    ·To determine the efficacy of cediranib when added to cisplatin plus a fluoropyrimidine compared to cisplatin plus a fluoropyrimidine alone by assessment of progression free survival (PFS), objective response rate and duration of response.
    ·To determine the safety and tolerability of cediranib when added to cisplatin plus a fluoropyrimidine compared to cisplatin plus a fluoropyrimidine alone.
    ·To determine the effects of cediranib when added to cisplatin plus a fluoropyrimidine compared to cisplatin plus a fluoropyrimidine alone on the global health status/QoL scale of the EORTC QLQ-C30 questionnaire.
    ·To investigate the pharmacokinetics of cediranib when added to cisplatin plus a fluoropyrimidine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures
    2. Female or male aged 18 years or older
    3. Histological or cytological confirmation of gastric adenocarcinoma (including the gastric cardia and esophagogastric junction)
    4. Locally advanced or metastatic gastric cancer. In patients with locally advanced disease the cancer must be considered unresectable
    5. Patients must have received no prior systemic therapy for advanced disease. Neoadjuvant and adjuvant therapy received > 6 months prior to entry into the study is acceptable
    6. WHO Performance score of 0 or 1
    7. Able to take oral medication
    8. Life expectancy ≥ 12 weeks
    9. At least one lesion (measurable or non measurable) that can be accurately assessed by CT or MRI at baseline and follow-up visits.
    For inclusion in the optional genetic research and biomarker analysis components of the study (blood and archival tumour sampling for DNA extraction and retrospective pharmacogenetic analysis and tumour biomarker analysis), patients must fulfil the following criteria:
    10. Provision of written informed consent for blood sampling for genetic research
    and/or
    11. Provision of written informed consent for tumour biomarker analysis
    E.4Principal exclusion criteria
    1.Untreated unstable brain or meningeal metastases. Patients with radiological evidence of stable brain metastases are eligible providing that they are asymptomatic and either do not require corticosteroids or have been treated with corticosteroids, with clinical and radiological evidence of stabilisation at least 10 days after discontinuation of steroids
    2.Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count ≤1.5 x 10*9/L or platelet count ≤100 x 10*9/L or requiring regular blood transfusions to maintain haemoglobin >8.5g/dL
    3.Serum bilirubin ≥ 1.5 x ULRR (except for patients with known documented cases of Gilbert’s syndrome)
    4.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 x ULRR. If liver metastases are present, ALT or AST > 5 x ULRR
    5.Serum creatinine > ULRR or a creatinine clearance of ≤ 60mL/min calculated by Cockcroft-Gault
    6.Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart unless urinary protein < 1.5g in a 24 hr period or protein/creatinine ratio < 1.5
    7.A history of poorly controlled hypertension or resting BP >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy (measurements will be made after the patient has been resting supine for a minimum of 5 minutes. Two or more readings should be taken at 2-minute intervals and averaged. If the first two diastolic readings differ by more than 5 mmHg, then an additional reading should be obtained and averaged)
    8.Any evidence of severe or uncontrolled systemic diseases (eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
    9.Any unresolved toxicity >CTC grade 1 from previous systemic anti-cancer therapy (including radiotherapy) except haematological toxicity (see exclusion #2) and alopecia
    10.Mean QTc with Bazetts correction >470msec in screening ECG or history of familial long QT syndrome
    11.Recent (<14 days) major thoracic or abdominal surgery prior to entry into the study, or a surgical incision that is not fully healed
    12.Pregnant or breast-feeding women or women of childbearing potential with a positive pregnancy test prior to receiving study medication
    13.Known severe hypersensitivity to cediranib, capecitabine (or TS-1 in Japan), cisplatin or any of the excipients of these products
    14.History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of advanced gastric adenocarcinoma from a non-target lesion
    15.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    16.Previous enrolment or randomisation in the present study
    17.Treatment with an investigational (non-registered) drug within 30 days prior to the first dose of cediranib
    18.Other concomitant anti-cancer therapy (including luteinising hormone releasing hormone [LHRH] agonists) except steroids
    19.Prior cisplatin therapy within 6 months of the first dose of cediranib
    20.Total previous culmulative dose of cisplatin exceeding 300mg/m2
    21.Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptors, including bevacizumab and cediranib
    22.Known DPD (dihydropyrimidine dehydrogenase) deficiency
    23.Known neuropathy > Grade 2
    24.History of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib and/or capecitabine
    25.Known risk of the patient transmitting HIV via infected blood or with active or chronic hepatitis B or C infection
    26.Significant haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks)
    27.Requiring intravenous nutritional support
    28.Ascites that require repeated drainage (more than once per week)
    29.Arterial thromboembolic event (including ischemic attack) in the previous 12 months
    Patients will be excluded from the optional genetic research of the study if they do not meet the exclusion criteria specified above, or the following:
    30. Previous allogenic bone marrow transplant.
    31. Non-leukocyte depleted whole blood transfusion in 120 days of genetic sample collection.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival, defined as the time from randomisation until death by any cause.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 730
    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 Decision2010-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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