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    Summary
    EudraCT Number:2008-006796-80
    Sponsor's Protocol Code Number:TES10897
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2008-006796-80
    A.3Full title of the trial
    The QUTIE Study: A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc interval in Cancer Patients treated with Docetaxel
    A.3.2Name or abbreviated title of the trial where available
    QUTIE
    A.4.1Sponsor's protocol code numberTES10897
    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 SponsorSanofi-Aventis Recherche & Développement
    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 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 nameAflibercept / VEGF Trap
    D.3.2Product code AVE0005
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAVE0005
    D.3.9.3Other descriptive nameVEGF Trap - Aflibercept
    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) 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 typerecombinant protein consisting of sequences derived from human VEGF receptor extracellular domains fused to Fc portion of human IgG1.
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11.0
    E.1.2Level LLT
    E.1.2Classification code 10007050
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect on QTcF interval (QTc Fridericia) of aflibercept versus placebo, in cancer patients.
    E.2.2Secondary objectives of the trial
    To assess the effects of aflibercept versus placebo on heart rate (HR), QT, QTcB (Bazett’s correction), and QTcN (population specific correction formula) intervals.
    To assess the overall clinical safety of the two treatment arms.
    To assess the PK profile of aflibercept (administered every 3 weeks) over 3 cycles.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient has a solid malignancy, documented by pathologic report, for which treatment with single-agent docetaxel (administered every 3 weeks, at dose <75 mg/m2 ) is planned
    • Written informed consent
    E.4Principal exclusion criteria
    • Related to study metho
    QT interval assessment
    - Prior history of torsades de pointe, or congenital long QT syndrome
    - Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter
    - QTcF interval >480 msec on screening ECG
    - Significant hypokalemia at screening (K+ <3.5 mMol/L)
    - Significant hypomagnesemia at screening (Mg++ <0.7 mMol/L)
    - Patient receives (and cannot discontinue), or is scheduled to receive, a concomitant treatment known to carry a risk of both QT prolongation and torsade de pointe
    - Known allergy or intolerance to palonosetron
    Cancer history
    - Patient has received more than 2 prior lines of cytotoxic-containing chemotherapy
    - Non-small cell lung cancer with squamous histology
    - Less than 28 days elapsed from prior chemotherapy, radiotherapy, or surgery to rando. Less than 42 days elapsed from prior major surgery to rando.
    - Persistent adverse events of grade >1 (NCI CTCAE v3.0) from prior therapy (except alopecia and those listed in exclusion criteria) at time of rando
    - Prior treatment with anthracyclines at a cumulative dose putting patient at significant risk of cardiac failure
    - Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >25% of the total bone marrow
    - Planned or anticipation of treatment with surgery, radiation therapy or any chemotherapy (including targeted therapy) other than study treatment
    - History of brain metastases, uncontrolled spinal cord compression, carcinomatosis meningitits, or new evidence of brain or leptomeningeal disease
    Other patient characteristics or medical history
    - Age <18 yrs
    - ECOG performance status >1
    - Participation in another clinical trial or concurrent treatment with any investigational agent within 28 days prior to rando
    - History of another neoplasm. Adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for >5 yrs are allowed.
    - Any of the following events within 3 months prior to rando: treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, grade 3 or 4 gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
    - Any of the following events within the 6 months prior to rando: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft surgery, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
    - Occurrence of deep vein thrombosis within 4 weeks prior to rando.
    - Acquired immunodeficiency syndrome or known human immunodeficiency virus disease requiring antiretroviral treatment
    - Any condition or situation which would make patient unlikely to complete at least 3 cycles of double-blind treatment, or which would interfere with interpretation of study results
    - Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to rando.
    - Patient with reproductive potential who does not agree to use accepted and effective method of contraception during the study treatment period and for at least 3 months after the completion of the study treatment. The definition of effective method of contraception will be based on the investigators’ judgment.
    • Related to docetaxel
    - History of hypersensitivity to docetaxel or polysorbate 80
    - Inadequate organ and bone marrow function as evidenced by: Hemoglobin <10.0 g/dL, Absolute neutrophil count <1.5 x 10^9/L, Platelet count <100 x 10^9/L, AST/SGOT and/or ALT/SGPT >2.5 x ULN, Alkaline phosphatase (AP) >5 x ULN, AST/SGOT and/or ALT/SGPT >1.5 x ULN concomitant with AP >2.5 x ULN, Total bilirubin >1.0 x ULN
    • Related to aflibercept
    - History of prior discontinuation of any anti-VEGF agent due to adverse events considered related to this class of agents
    - Urine protein:creatinine ratio (UPCR) >1 on morning spot urinalysis or proteinuria >500 mg/24h.
    - Serum Creatinine >1.5 x ULN (if creatinine 1.0 - 1.5 x ULN, creatinine clearance <60 mL/min)
    - Uncontrolled hypertension, defined as blood pressure >150/100 mm Hg (grade ≥ 2 according to NCI CTCAE v.3.0), or systolic blood pressure >180 mm Hg if diastolic blood pressure <90 mm Hg, on at least 2 repeated determinations on separate days, within 3 months prior to study rando.
    - Patients on anticoagulant therapy with unstable dose of warfarin and/or having an out-of-therapeutic range INR (>3) within 4 weeks prior to rando.
    - Evidence of clinically significant bleeding diathesis including hemoptysis, or underlying coagulopathy
    - Evidence of significant non-healing wound
    - History of abdominal fistula, gastrointestinal perforation, intra-abdominal abcess, or clinically significant bowel obstruction within 3 months prior to rando.
    E.5 End points
    E.5.1Primary end point(s)
    QTcF, derived from manually read QT interval.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 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 No
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 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 years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 80
    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 Decision2009-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-08
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