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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:2007-003592-39
    Sponsor's Protocol Code Number:EFC10145
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-18
    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 number2007-003592-39
    A.3Full title of the trial
    A multinational, randomized, double-blind placebo controlled study of AVE8062 (25 mg/m²) administered every 3 weeks in patients with advanced-stage soft tissue sarcoma, treated with cisplatin (75 mg/m²) after failure of anthracycline and ifosfamide chemotherapies.
    Antraciklin- és ifoszfamid-kemoterápia sikertelenségét követően ciszplatinnal (75 mg/m²) kezelt, előrehaladott stádiumú lágyrész-szarkómás betegeknél 3 hetenként alkalmazott AVE8062 (25 mg/m²) multinacionális, randomizált, kettős-vak, placebo-kontrollos vizsgálata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies
    A.4.1Sponsor's protocol code numberEFC10145
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00699517
    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 recherche et 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 supportsanofi-aventis recherche et développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis Zrt.
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street AddressTó u. -1-5.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1045
    B.5.3.4CountryHungary
    B.5.6E-mailkapcsolat@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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/141/10
    D.3 Description of the IMP
    D.3.2Product code AVE8062
    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 INNOmbrabulin
    D.3.9.1CAS number 253426-24-3
    D.3.9.2Current sponsor codeAVE8062 hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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 No
    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 Yes
    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 namecisplatin
    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 INNcisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) 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 No
    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 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
    Advanced-stage soft tissue sarcoma treated with cisplatin after failure of anthracycline and ifosfamide chemotherapies.
    E.1.1.1Medical condition in easily understood language
    Advanced-stage soft tissue sarcoma treated with cisplatin after failure of anthracycline and ifosfamide chemotherapies.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10041299
    E.1.2Term Soft tissue sarcomas
    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 compare the progression-free survival (PFS) in the 2 treatment arms
    E.2.2Secondary objectives of the trial
    - To compare the overall survival (OS) in the 2 treatment arms
    - To compare the objective response rate (RR) in the 2 treatment arms
    - To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
    - To assess the pharmacokinetics (PK) of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.
    -To assess genotypes of drug metabolizing enzymes in all enrolled patients in blood sampling collected before the first study drug infusion.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically proven STS at the first diagnosis.
    - Unresectable locoregional recurrent OR metastatic soft tissue sarcoma
    - Failure of a previous anthracycline-based regimen administered at recommended dose and of prior ifosfamide therapy
    - Disease progression within 1 month before study randomization
    E.4Principal exclusion criteria
    - Patient consent form not obtained, signed and dated
    - Less than 18 years old
    - ECOG Performance Status (PS) > 2
    - Life expectancy shorter than 12 weeks.
    - Patients with well controlled primary disease and who are candidates to total surgical resection of metastasis (1 or more lesions) before study randomization.
    - Brain metastases and carcinomatous leptomeningitis.
    - More than two previous chemotherapy regimens for advanced disease.
    - Prior intensive chemotherapy with autologous stem cell rescue
    - Prior treatment with Tyrosine Kinase inhibitors (TKI) (specific or multitargeted agents)
    - History of other cancer. Adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for > 5 years are allowed.
    - Only lesions previously irradiated (i.e. lesions not evaluable) if no other evaluable lesions are present. At study entry, in the case of one single metastatic target lesion, histological or cytological proof to metastasis should be obtained.
    - Pregnant or breast-feeding women. Positive serum or urine pregnancy test for women prior to randomization
    - Patients with reproductive potential (M/F) who do 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 investigator’s judgment. For patients enrolled in the United Kingdom, the following method of contraception are acceptable: Oral contraceptives accompanied by the use of a second method of contraception (as it is not known how oral contraceptives interact with all the study medications) or Intra Uterine Device (IUD) or women who are surgically sterile or women who are post-menopausal or for other reasons have no chance of becoming pregnant. Female partners of male patient must follow the same contraceptive methods as mentioned above.
    - Washout period of less than 3 weeks from prior anti-tumor therapy (chemotherapy, targeted agents, and radiotherapy) or any investigational treatment, except for nitrosoureas, mitomycin C which may not be used up to 6 weeks prior to the randomization date provided that patients do not have residual signs of any toxicity.
    - Complete initial work up earlier than 3 weeks prior to patient randomization.
    - Patient’s inability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
    - Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, radiotherapy, targeted therapy, gene therapy, or patients planning to receive these treatments during the study.
    - Other severe illness or medical conditions such as and not exhaustive :
    1. Active infection.
    2. Superior Vena Cava Syndrome.
    3. Severe chronic obstructive pulmonary disease (COPD) and/or extensive pulmonary fibrosis (arterial blood gases PAO2 < 60 or non invasive oximetry SaO2 < 90).
    4. Pericardial effusion requiring intervention (drainage).
    5. Severe proteinuria (Grade 3-4, > 3.5 g/24h).
    - Patient with LVEF value lower than 50 % for institution inferior normal limit, evaluated by echocardiography, or by radionuclide assessment.
    - Ischemic event within 1 year prior to study entry including but not limited to: stroke, angor, whatever the anatomical site, diagnosis of at least one symptomatic coronary insufficiency
    - Uncontrolled hypertension
    - Uncontrolled arrhythmia particularly severe conduction disorder such as second or third-degree atrio-ventricular block
    - Thrombo-embolism requiring anticoagulants within the past 6 months.
    1. Blood marrow: neutrophils < 1.5 x 109/L; platelets <100 x 109/L
    2. Kidney function: creatinine > 1.5 mg/dl. If creatinine ≥ 1.5 mg/dl, the calculated creatinine clearance should be ≥ 60 ml/min (Cockroft-Gault Formula).
    3. Liver function: Total bilirubin value > normal limit; ALT/AST/AP ≥ 2.5 times the upper normal limits of the institutional norms. An increase of AP (≥ grade 2) would be accepted only if this increase is related to the presence of bone metastases.
    4. Known platinum hypersensitivity
    5. Current peripheral neuropathy > grade 1 according to the NCI CTCAE classification, of any origin including symptoms due to the use of neurotoxic drugs (e.g. vinca-alkaloids, platinum or taxans).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is progression-free survival (PFS) defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever comes first. An independent review committee (IRC) blinded to the randomization arm and to the
    patient characteristics, will assess objective radiological tumor progression.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The cutoff will be the date when 265 Progression free survival events have occurred.
    E.5.2Secondary end point(s)
    •Overall survival
    •Response rate
    •Safety profile
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Overall Survival: The cutoff will be the date when both approximately 260 deaths and 265 PFS events have occurred

    - Response Rate: The cutoff will be the date when both approximately 260 deaths and 265 PFS events have occurred

    - Safety Profile: The cutoff will be the date when both approximately 260 deaths and 265 PFS events have occurred

    All these endpoints will be analyzed at the same time, when the targeted number of events will be reached for PFS and OS endpoints

    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    All patients will be treated with cisplatin as background therapy
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Brazil
    India
    Serbia
    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
    Last visit of the last subject
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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 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.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 350
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable
    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 Decision2008-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-17
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