{ "FullStudy":{ "Rank":217995, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514123", "OrgStudyIdInfo":{ "OrgStudyId":"VGX-100-1001" }, "Organization":{ "OrgFullName":"Circadian Technologies Ltd.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study of VGX-100 Administered Alone and Co-administered With Bevacizumab in Adult Subjects With Advanced Solid Tumors", "OfficialTitle":"A Phase I, Open Label, Dose Escalation Study of the VEGF-C Human Monoclonal Antibody VGX-100 Administered by Intravenous Infusion Alone and Co-administered With Bevacizumab in Adult Subjects With Advanced or Metastatic Solid Tumors" }, "StatusModule":{ "StatusVerifiedDate":"July 2017", "OverallStatus":"Unknown status", "LastKnownStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2017", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"November 2017", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 21, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 25, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Circadian Technologies Ltd.", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This is a non-randomized, multi-dose, first-in-human, multicenter, two arm (Arm A: VGX-100 alone; Arm B: VGX-100 co-administered with bevacizumab), open label, dose escalation study in subjects with advanced or metastatic solid tumors. The study is aimed at evaluating the safety and establishing the recommended dose of the VEGF-C human monoclonal antibody VGX-100 when administered alone or in combination with bevacizumab." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Neoplasms", "Cancer" ] }, "KeywordList":{ "Keyword":[ "VGX-100", "Bevacizumab", "VEGF-C", "First-In-Human", "Dose Escalation", "Advanced Solid Tumors", "Angiogenesis Inhibitors", "Angiogenesis Modulating Agents", "Pharmacologic Actions", "Antibodies, Monoclonal", "Phase 1", "Oncology", "Advanced malignancy" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"40", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Arm A - VGX-100 alone", "ArmGroupType":"Experimental", "ArmGroupDescription":"Dose escalation of VGX-100 monotherapy", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: VGX-100" ] } },{ "ArmGroupLabel":"Arm B - VGX-100 plus bevacizumab", "ArmGroupType":"Experimental", "ArmGroupDescription":"Dose escalation of VGX-100 in combination with escalating doses of bevacizumab", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: VGX-100", "Drug: Bevacizumab" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"VGX-100", "InterventionDescription":"VGX-100 will be administered by IV infusion once every week", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm A - VGX-100 alone", "Arm B - VGX-100 plus bevacizumab" ] } },{ "InterventionType":"Drug", "InterventionName":"Bevacizumab", "InterventionDescription":"Bevacizumab will be administered by IV infusion once every 2 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm B - VGX-100 plus bevacizumab" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Avastin" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The incidence and severity of adverse events including dose limiting toxicities", "PrimaryOutcomeTimeFrame":"Approximately 16 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Tumor response by RECIST criteria", "SecondaryOutcomeDescription":"Tumor response assessment will be measured by computated tomography (CT) or Magnetic resonance imaging (MRI) every 8 or 12 weeks throughout the study", "SecondaryOutcomeTimeFrame":"Approximately 16 months" },{ "SecondaryOutcomeMeasure":"Pharmacokinetic parameters of VGX-100 alone and co-administered with bevacizumab including Cmax, Cmin, AUC and if feasible half life (t1/2)", "SecondaryOutcomeTimeFrame":"28 days after the last subject in each cohort" },{ "SecondaryOutcomeMeasure":"Anti-VGX-100 antibody formation", "SecondaryOutcomeTimeFrame":"Approximately 16 months" },{ "SecondaryOutcomeMeasure":"Biomarker levels including VEGF-A, VEGF-C, VEGF-D, soluble VEGFR-2, and soluble VEGFR-3", "SecondaryOutcomeTimeFrame":"Approximately 16 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAge ≥ 18 years\nProvision of written informed consent\nHistologically or cytologically documented advanced or metastatic solid tumor that is refractory to standard treatment, for which no standard therapy is available, or for which the subject refuses standard therapy\nLife expectancy > 3 months in the opinion of the investigator\nECOG performance status 0 to 1\nEvaluable OR measurable disease by RECIST 1.1 criteria\nAgree to the use of effective contraceptive if either male or female of child bearing potential\n\nExclusion Criteria:\n\nInadequate venous access\nWomen who are lactating/breastfeeding\nWomen with a positive pregnancy test or who are planning to become pregnant during the duration of the study\nKnown to be HIV positive, or have chronic hepatitis B or C\nMajor surgical procedure within 6 weeks of Baseline or surgical or other wound that is not fully healed at Baseline\nUntreated or symptomatic brain metastasis, known central nervous system metastasis, or spinal cord compression (except glioblastoma multiforme)\nMediastinal or cavitated, or lung mass located near, invading or encasing a major blood vessel or airway on imaging\nSquamous cell lung cancer\nHistory of or known/suspected gastrointestinal perforation\nHemoptysis of >2.5 mL (half a teaspoon) red blood within 28 days of Screening\nDeep venous thrombosis or history of symptomatic pulmonary thromboembolism within 6 months of Screening\nGastrointestinal bleeding requiring medical intervention within 28 days of Screening\nReceipt of therapeutic concentrations of warfarin or other anticoagulants within 7 days of Screening\nReceipt of investigational agent(s) for any indication within 28 days of Baseline or 5 half lives, whichever is greater\n\nReceipt of the following treatments:\n\nTraditional cytotoxics, tyrosine kinase inhibitors or other small molecule anti-cancer agents within 21 days\nNitrosoureas, mitomycin C, bevacizumab or trastuzumab within 6 weeks\nAny other therapeutic monoclonal antibodies within 21 days\nHormonal therapy (other than gonadal suppression) within 14 days\n\nRadiotherapy:\n\nto >25% bone marrow\nto brain within 28 days of baseline\nother than above within 14 days of baseline\nUnstable angina, myocardial infarction, transient ischemic events, or stroke within 24 weeks of Screening\nHistory of CNS hemorrhage, cerebrovascular hemorrhage, myocardial infarction or reversible posterior leukoencephalopathy syndrome associated with prior anti-VEGF/anti-VEGFR therapy\nUncontrolled hypertension of ≥ CTCAE Grade 2\nProteinuria at Baseline of ≥2+ or 1.0g/24 hours\nPrior allergic reaction to a monoclonal antibody", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Clinical Research", "OverallOfficialAffiliation":"Circadian Technologies", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"UCLA Hematology-Oncology", "LocationCity":"Santa Monica", "LocationState":"California", "LocationZip":"90404", "LocationCountry":"United States" },{ "LocationFacility":"UT MD Anderson Cancer Center", "LocationCity":"Houston", "LocationState":"Texas", "LocationZip":"77030", "LocationCountry":"United States" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Undecided" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000068258", "InterventionMeshTerm":"Bevacizumab" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000074322", "InterventionAncestorTerm":"Antineoplastic Agents, Immunological" },{ "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000020533", "InterventionAncestorTerm":"Angiogenesis Inhibitors" },{ "InterventionAncestorId":"D000043924", "InterventionAncestorTerm":"Angiogenesis Modulating Agents" },{ "InterventionAncestorId":"D000006133", "InterventionAncestorTerm":"Growth Substances" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000006131", "InterventionAncestorTerm":"Growth Inhibitors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M246", "InterventionBrowseLeafName":"Bevacizumab", "InterventionBrowseLeafAsFound":"Bevacizumab", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M1346", "InterventionBrowseLeafName":"Antineoplastic Agents, Immunological", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M20902", "InterventionBrowseLeafName":"Angiogenesis Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } } } } } }