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    Summary
    EudraCT Number:2006-000604-16
    Sponsor's Protocol Code Number:ARD 6722
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-000604-16
    A.3Full title of the trial
    A Multicenter, Open-Label, Single-Arm Study of Intravenous AVE0005 VEGF Trap Administered Every 2 Weeks in Advanced Ovarian Cancer Patients with Recurrent Symptomatic Malignant Ascites
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberARD 6722
    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 SponsorSanofi-Synthelabo Recherche, a subsidiary of sanofi-aventis group
    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 Information not present in EudraCT
    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 nameVEGF-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.3.9.1CAS number 862111-32-8
    D.3.9.2Current sponsor codeAVE0005
    D.3.9.3Other descriptive nameVEGF-TRAP
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced ovarian cancer patients with recurrent symptomatic malignant ascites
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10025538
    E.1.2Term Malignant ascites
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimate the repeat paracentesis response rate RPRR in advanced ovarian cancer patients with recurrent symptomatic malignant ascites
    E.2.2Secondary objectives of the trial
    Estimate the general safety and tolerability of AVE0005 VEGF Trap in advanced ovarian cancer patients with recurrent symptomatic malignant ascites. Estimate the effect of AVE0005 VEGF Trap treatment on time to repeat paracentesis TRP and 60-day frequency of paracentesis FOP . Estimates the effect of AVE0005 VEGF Trap treatment on progression-free survival PFS , and overall survival OS in advanced ovarian cancer patients with recurrent symptomatic malignant ascites. Determine if human anti-AVE0005 VEGF Trap antibodies develop in advanced ovarian cancer patients with recurrent symptomatic malignant ascites treated with AVE0005 VEGF Trap
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures and agrees to participate in the study by providing written informed consent prior to any study-related requirements. 2. Patient is female or equal to 18 years of age. 3. Patient has symptomatic malignant ascites resulting from advanced ovarian epithelial cancer including fallopian tube and primary peritoneal adenocarcinoma that has required at least 3 previous therapeutic paracenteses at a frequency of 1-4 paracenteses per month for management. 4. Platinum-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance. 5. Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance. 6. Patient underwent Day 1 paracentesis for symptoms consistent with abdominal discomfort, bloating, or pain with or equal to 1 liter of ascitic fluid removed. 7. Patient has an Eastern Cooperative Oncology Group ECOG performance status or equal to 2. 8. Patient is postmenopausal, surgically sterile, or using effective contraception. 9. Patient has adequate organ and bone marrow function as evidenced by hemoglobin or equal 8.0 g/dL; absolute neutrophil count or equal to 1.0 x 10 9 /L platelet count or equal to 75 x 10 9 /L creatinine or equal to 1.5 x ULN, and either proteinuria or equal to 500 mg/24 hours or urine protein creatinine ratio UPCR or equal to 1; AST/SGOT, ALT/SGPT, and total bilirubin or equal to 2.5 x ULN; international normalized ratio INR within normal limits or or equal to 1.5 x ULN if on prophylactic anticoagulation and activated partial thromboplastin time aPTT within normal limits.
    E.4Principal exclusion criteria
    1. Patient has pseudomyxoma peritonei or peritoneal mesothelioma. 2. Patient has radiographic evidence of intestinal obstruction e.g., dilated loops of bowel accompanied by air-fluid levels requiring surgical intervention or gastrointestinal perforation e.g., presence of extraluminal gas requiring surgical intervention. 3. Patient has ascites associated with a non-malignant condition, including but not limited to ascites associated with mechanical obstruction, congestive heart failure, constrictive pericarditis, portal hypertension, hypoproteinemia of hepatic failure or nephrotic syndrome often associated with serum to ascites albumin gradient 1.1, i.e. transudative ascites . 4. Patient has a peritoneovenous or other type of shunt that was placed for the management of ascites. 5. Anticipation of need for a major surgical procedure or radiation therapy during the study. 6. Likelihood of requiring treatment during the study period with drugs or devices not permitted by the clinical trial protocol. 7. Patient has had any of the following conditions within 6 months prior to study entry myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, peptic ulcer disease, erosive esophagitis or gastritis, hepatic cirrhosis, portal venous obstruction, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, deep vein thrombosis, or other thromboembolic event. 8. Patient has uncontrolled hypertension with or without antihypertensive drug treatment , defined as blood pressure 150/100 mm Hg or systolic blood pressure 180 mm Hg on at least 2 repeated determinations on separate days within 3 months prior to study entry. 9. Patient has received tumor-directed immunologic therapy, targeted therapy, radiation therapy, surgery, chemotherapy, or an investigational agent including FDA approved drugs for a non-FDA approved indication within 3 weeks prior to study entry. For major surgery, mitomycin or nitrosoureas, there must be a 6-week treatment-free interval. 10. Patient has a known history of hypersensitivity to any Trap agent or recombinant proteins. 11. Patient has been previously treated with AVE0005 VEGF Trap , bevacizumab, or other inhibitor of VEGF or VEGFR. 12. Patient has a serious, unresolved complication of malignant disease including, but not limited to, untreated superior vena cava syndrome, spinal cord compression, or refractory hypercalcemia of malignancy. 13. Patient has previously known brain metastases, spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. 14. Patient has known, clinically significant, active infection or bleeding, or underlying bleeding disorder. 15. Patient has a history of any condition social or medical that, in the opinion of the investigator, might confound the results of the study, or pose additional, unacceptable risk to the patient. 16. Patient is pregnant, breastfeeding, planning to become pregnant or unwilling to use effective contraception. 17. Patient is mentally or legally incapacitated unable to understand the nature, scope and possible consequences of the study at the time of the study or has been 1 year prior to study entry a user of illicit drugs or abuser of alcohol. 18. Patient is unlikely to either comply with the protocol e.g., uncooperative attitude, inability to return for follow-up visits , or complete the study. 19. Patient has been previously registered in this study
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be repeat paracentesis response RPR defined as at least a twofold increase in TRP as compared to the average of the 2 intervals between the 3 most recent paracenteses prior to study registration. TRP will be defined as the number of days between the date of registration and the date of the first post-registration paracentesis. For this endpoint, each patient will be followed for 6 months or until study withdrawal.
    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 No
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 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.8.5The 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 Information not present in EudraCT
    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 years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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 No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-10-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    pazienti vulnerabili
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 15
    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 Decision2006-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-06
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