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    The EU Clinical Trials Register currently displays   38596   clinical trials with a EudraCT protocol, of which   6341   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-005505-64
    Sponsor's Protocol Code Number:AVAST-M
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-02-22
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2006-005505-64
    A.3Full title of the trial
    A Randomised Trial Evaluating the VEGF Inhibitor, Bevacizumab (Avastin), as Adjuvant Therapy following Resection of AJCC Stage IIB (T3bN0M0 & T4aN0M0), IIC (T4bN0M0) and III (TxN1-3M0) Cutaneous Melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial looking at bevacizumab after surgery for melanoma skin cancer (AVAST-M)
    A.3.2Name or abbreviated title of the trial where available
    AVAST-M
    A.4.1Sponsor's protocol code numberAVAST-M
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN81261306
    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 SponsorCambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationCambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
    B.5.2Functional name of contact pointSabine Klager
    B.5.3 Address:
    B.5.3.1Street AddressClinical Trials Office, Addenbrooke's Hospital
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB2 0QQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4401223348179
    B.5.5Fax number+4401223348071
    B.5.6E-mailsabine.klager@addenbrookes.nhs.uk
    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 Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBevacizumab
    D.3.2Product code RO4876646
    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 INNBevacizumab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive namerhuMab, VEGF, anti-VEGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100mg/4ml
    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 humanised monoclonal antibody
    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.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBevacizumab
    D.3.2Product code RO4876646
    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 INNBevacizumab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive namerhuMab, VEGF, anti-VEGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400mg/16ml
    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 humanised monoclonal antibody
    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
    Patients at high risk of recurrence after resection of cutaneous melanoma:
    those patients with histological confirmation of completely resected AJCC stage IIB (T3bN0M0 & T4aN0M0), IIC (T4bN0M0) and III (TxN1-3M0) cutaneous melanoma
    E.1.1.1Medical condition in easily understood language
    A type of skin cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 overall survival of patients treated with bevacizumab, compared with standard observation after resection of high risk melanoma
    E.2.2Secondary objectives of the trial
    The study will also compare the two arms of the study in terms of the following parameters:
    • Disease free interval
    • Distant metastatis-free interval
    • Safety and toxicity
    • Quality of life
    • Measurement of angiogenesis biomarkers in tissue and peripheral blood to identify potential prognostic and predictive indicators
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Written informed consent
    •Age ≥16 years
    •Able to comply with the protocol
    •Patients with histological confirmation of completely resected AJCC stage IIB (T3bN0M0 & T4aN0M0), IIC (T4bN0M0) and III (TxN1-3M0) cutaneous melanoma
    •Patients may or may not have undergone sentinel lymph node dissection and/or elective lymph node dissection
    •Patients must be randomised within 12 weeks of completing latest surgery for melanoma
    •For patients with resected stage IIB or IIC disease, when wide local excision is undertaken after resection of primary melanoma, the interval between the two procedures must be ≤ 12 weeks.
    •For patients where sentinel lymph node biopsy followed by complete lymph node dissection is the latest surgery for melanoma, the time between the two procedures must be ≤ 12 weeks.
    •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    •Life expectancy ≥ 6 months
    •Blood pressure systolic ≤150 and diastolic ≤100 mmHg.
    •Adequate haematological function:
    oAbsolute neutrophil count (ANC) ≥1.5 x 109/L AND
    oPlatelet count ≥100 x 109/L AND
    oHaemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level)
    •Adequate liver function (unless pre-existing abnormality):
    oTotal bilirubin <1.5 x upper limit of normal (ULN) AND
    oAsparagine aminotransferase (AST), and/or alanine aminotransferase (ALT) <2 x ULN
    •Adequate renal function:
    oSerum creatinine ≤1.25 x ULN or calculated creatinine clearance ≥50 mL/min AND
    oUrine dipstick for proteinuria <2+. Patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤1 g of protein in 24 hours AND
    oProthrombin time (PT) and Partial thromboplastin time (PTT/aPTT) ≤1.5 x ULN
    •Negative pregnancy test (serum or urine dipstick) for women of child bearing potential (WOCBP)
    •Adequate contraception:
    oWomen of child bearing potential (WOCBP) must agree to use, effective non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) if randomised to the treatment arm and for a period of 6 months following the last administration of bevacizumab.
    oMen must agree to use effective contraception if randomised to the treatment arm and for a period of 90 days following the last administration of bevacizumab.
    E.4Principal exclusion criteria
    •Non-cutaneous melanoma as the primary disease site
    •Any evidence of distant or non-regional lymph node metastases
    •Evidence of CNS metastases.
    •Incomplete surgical resection of the disease
    •Adjuvant radiotherapy ongoing at randomisation
    •Prior chemotherapy, immunotherapy, or hormonal therapy for melanoma within 12 weeks of randomisation
    •Any surgery (including open biopsy, but excluding insertion of an indwelling catheter), or significant traumatic injury within 28 days prior to randomisation, or anticipation of the need for surgery during study treatment including invasive dental surgery
    •Current or recent (within 7 days of randomisation) use of aspirin (> 300 mg/day) or clopidogrel (> 75 mg/day)
    •Current or recent (within 7 days of randomisation) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed
    •History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
    •Clinically significant (i.e. active) cardiovascular disease for example CVA (≤6 months before randomisation), myocardial infarction (≤6 months before randomisation), unstable angina, congestive heart failure NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication
    •Unhealed wound, active peptic ulcer or bone fracture
    •History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of randomisation
    •Pregnant or breast-feeding females.
    •Treatment with any other investigational agent within 28 days prior to randomisation
    •Known hypersensitivity to bevacizumab or any of its excipients
    •Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
    •Any condition, which, in the opinion of the investigator, might interfere with the safety of the patient or evaluation of the study objectives
    •Previous malignancy in the last 5 years (patients must have been continuously disease free for 5 years prior to the time of randomisation) except for curatively treated basal or squamous cell skin cancers or in situ malignancies
    E.5 End points
    E.5.1Primary end point(s)
    To determine the overall survival of patients treated with bevacizumab, compared with standard observation after resection of high risk melanoma
    E.5.1.1Timepoint(s) of evaluation of this end point
    March 2017 - Anticipated analysis with a minimum follow-up of 5 years
    E.5.2Secondary end point(s)
    The study will also compare the two arms of the study in terms of the following parameters:
    • Disease free interval
    • Distant metastasis-free interval
    • Safety and toxicity
    • Quality of life (QoL)
    • Measurement of angiogenesis biomarkers in tissue and peripheral blood to identify potential prognostic and predictive indicators
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard observation
    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 concerned45
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    End of trial is defined by the last visit of the last patient undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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 Yes
    F.1.1Number of subjects for this age range: 5
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1320
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1320
    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)
    Expected normal treatment of that condition
    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 Decision2007-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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