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    The EU Clinical Trials Register currently displays   42758   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-005724-17
    Sponsor's Protocol Code Number:AFLIBC06097
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-08
    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 ConcernedIreland - HPRA
    A.2EudraCT number2011-005724-17
    A.3Full title of the trial
    A Multicenter, Single arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients with Metastatic Colorectal Cancer (mCRC) Previously Treated with an Oxaliplatin-Containing Regimen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Quality of Life study of Aflibercept in patients with metastatic Colorectal
    Cancer previously treated with an oxaliplatin-based regimen
    A.4.1Sponsor's protocol code numberAFLIBC06097
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1125-8949
    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 SponsorSanofi aventis Groupe
    B.1.3.4CountryFrance
    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 organisationSanofi aventis Groupe
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressOne Onslow Street
    B.5.3.2Town/ cityGuildford - Surrey
    B.5.3.3Post codeGU14YS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441483505515
    B.5.6E-mailuk-medicalinformation@sanofi.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 nameAflibercept
    D.3.2Product code AVE0005
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAFLIBERCEPT
    D.3.9.1CAS number 862111-32-8
    D.3.9.2Current sponsor codeAVE0005
    D.3.9.3Other descriptive nameVEGF TRAP
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) 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 Yes
    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 typeRecombinant protein VEGF receptor extracellular domain fused to Fc portion of human IgG
    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
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    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 evaluate the safety of aflibercept in patients with metastatic Colorectal Cancer (mCRC) treated with irinotecan/5FU combination (FOLFIRI) after failure of an oxaliplatin-based regimen (patients similar to those evaluated in the VELOUR trial).
    E.2.2Secondary objectives of the trial
    To document the Health-Related Quality of Life (HRQL) in this patient population, to capture those utility values not collected during the conduct of the
    VELOUR study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically or cytologically proven adenocarcinoma of the colon or rectum
    Metastatic disease
    Eastern Cooperative Oncology Group performance status 0-1
    One and only one prior chemotherapeutic regimen for metastatic disease. This
    prior chemotherapy must be an oxaliplatin containing regimen. Patients must
    have progressed during or after the oxaliplatin based chemotherapy. Patients
    relapsed within 6 months of completion of oxaliplatin adjuvant chemotherapy are
    eligible.
    E.4Principal exclusion criteria
    Prior therapy with irinotecan
    Inadequate bone marrow, liver and renal function: neutrophils < 1.5x109/L,
    platelets < 100x109/L, hemoglobin < 9.0 g/dL, total bilirubin >1.5 x upper normal
    limit (ULN), transaminases >3 x ULN (unless liver metastasis are present),
    alkaline phosphatase >3 x ULN (unless liver metastasis are present), serum
    creatinine > 1.5 x ULN.
    Less than 4 weeks from prior radiotherapy, prior chemotherapy, prior major
    surgery (or until the surgical wound is fully healed).
    Treatment with any investigational drug within the prior 30 days.
    Treatment with concomitant anticonvulsivant agents that are CYP3A4 inducers
    (phenytoin, phenobarbital, carbamazepine), unless discontinued >7 days.
    History of brain metastases, uncontrolled spinal cord compression, or
    carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
    Prior malignancy (other than colorectal) including prior malignancy from which the
    patient has been disease free for < 5 years (except adequately treated basal or
    squamous cell skin cancer or carcinoma in situ of the cervix).
    Any of the following within 6 months prior to study inclusion: myocardial infarction,
    severe/unstable angina pectoris, coronary/peripheral artery bypass graft, severe
    congestive heart failure, stroke or transient ischemic attack.
    Any of the following within 3 months prior study inclusion: severe gastrointestinal
    bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive
    oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis,
    pulmonary embolism or other uncontrolled thromboembolic event.
    Occurrence of deep vein thrombosis within 4 weeks, prior to study inclusion.
    Known dihydropyrimidine dehydrogenase deficiency.
    Predisposing colonic or small bowel disorders in which the symptoms were
    uncontrolled.
    Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhea,
    unresolved bowel obstruction/sub-obstruction, more than hemicolectomy,
    extensive small intestine resection with chronic diarrhea.
    Known Gilbert’s syndrome.
    Unresolved or unstable toxicity from any prior anti cancer therapy at the time of
    inclusion.
    History of anaphylaxis or known intolerance to atropine sulphate or loperamide or
    appropriate antiemetics to be administered in conjunction with FOLFIRI
    (irinotecan, 5-Fluorouracil, leucovorin).
    Severe acute or chronic medical condition, which could impair the ability of the
    patient to participate to the study.
    Urine protein-creatinine ratio (UPCR) >1 on morning spot urinalysis or proteinuria
    > 500 mg/24-h.
    Uncontrolled hypertension within 3 months prior to study inclusion.
    Patients on anticoagulant therapy with unstable dose of warfarin and/or having an
    out-of-therapeutic range INR within the 4 weeks prior to study inclusion.
    Evidence of clinically significant bleeding predisposition or underlying
    coagulopathy, non-healing wound.
    Pregnant or breast-feeding women.
    Patients with reproductive potential who do not agree to use an accepted
    effective method of contraception.
    E.5 End points
    E.5.1Primary end point(s)
    - Number of participants reporting adverse events
    - Number of participants reporting laboratory
    abnormalities
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 30 days after the end of
    treatment
    E.5.2Secondary end point(s)
    Health-Related Quality of Life (HRQL) assessed by
    using changes from baseline in scores derived from
    the 3 HRQL questionnaires
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 4 weeks
    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 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 Yes
    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 Information not present in EudraCT
    E.8.1.2Open Yes
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Belgium
    Canada
    Chile
    Colombia
    Denmark
    Finland
    Germany
    India
    Ireland
    Israel
    Italy
    Netherlands
    Norway
    Spain
    Sweden
    United Kingdom
    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
    In each country, patient recruitment will end when
    aflibercept becomes commercially available (i.e. accessible to the patient as per each country
    regulation). Patients already included will continue to be treated until disease progression,
    death, unacceptable toxicity, Investigator’s decision or patient’s refusal of further treatment.
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 900
    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 Decision2013-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-31
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