{ "FullStudy":{ "Rank":217996, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514110", "OrgStudyIdInfo":{ "OrgStudyId":"GAT006" }, "Organization":{ "OrgFullName":"Chinese University of Hong Kong", "OrgClass":"OTHER" }, "BriefTitle":"Gastric Cancer RAD001 Study", "OfficialTitle":"Phase I/II Study of Paclitaxel / Carboplatin / RAD001 as First Line Therapy for Advanced Adenocarcinoma of the Stomach" }, "StatusModule":{ "StatusVerifiedDate":"March 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 23, 2008", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"March 6, 2019", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"March 6, 2019", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"November 22, 2011", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 31, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 2, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"CCTU", "ResponsiblePartyInvestigatorTitle":"Comprehensive Clinical Trial Unit", "ResponsiblePartyInvestigatorAffiliation":"Chinese University of Hong Kong" }, "LeadSponsor":{ "LeadSponsorName":"Chinese University of Hong Kong", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to determine dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of RAD001, as well as to assess tumor response and overall survival." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Gastric Cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1", "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"35", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"RAD001", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: RAD001" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"RAD001", "InterventionDescription":"Pharmacology of RAD001 as a combination partner for conventional agents.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "RAD001" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "RAD001 with Paclitaxel 175 mg/m2 and carboplatin (AUC=5) on Day 1, every 3 weeks until PD" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"to determine the Maximum tolerated dose and dose limiting toxicity of RAD001 in combination with paclitaxel and carboplatin", "PrimaryOutcomeTimeFrame":"2 years" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Toxicity of combination Paclitaxel/carboplatin/RAD001 in advanced adenocarcinoma of the stomach and gastroesophageal junction", "SecondaryOutcomeTimeFrame":"2 Years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHistologically or cytologically proven adenocarcinoma of the stomach. Patients who have adenocarcinoma of the gastroesophageal junction will be eligible if the majority of the tumor bulk is below the junction.\nMetastatic or Loco-regionally advanced disease\nPatients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT /MRI scan. See section 11.2 for the evaluation of measurable disease.\nAge >= 18 years.\nLife expectancy of greater than 12 weeks.\nECOG performance status <= 2 (Karnofsky >= 60%).\n\nExclusion Criteria:\n\nPatients who have received more than one line of palliative chemotherapy are allowed, provided that (i) the prior chemotherapy does not contain taxane, cisplatin or carboplatin; (ii) 4 weeks have elapsed prior to the start of the current study treatment, and that (iii) they have recovered from adverse events due to previous treatment [except alopecia].\nPatients who have had radiotherapy or major surgery within 4 weeks prior to entering the study or those who have not recovered from adverse events due to treatment administered more than 4 weeks earlier.\nPatients who are on CYP3A4 modifiers are excluded from the study\nPatients with known brain metastases.\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001.\n\nSignificant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.\n\nPatients with severe concurrent medical illness such as severe impairment of lung function should be excluded from studies of RAD001.\nUncontrolled intercurrent such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.\nPoorly controlled diabetes mellitus\nHigh LDL cholesterol or triglyceride level\nPre-existing neuropathy of >= grade 2\nPatients with a history of second malignancies are eligible they have been disease free for at least 5 years and are deemed by the investigator to be at low risk of recurrence. Par8entswith the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin\nPregnancy or lactation.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Winnie Yeo, MD, FRCP", "OverallOfficialAffiliation":"Department of Clinical Oncology, The Chinese University of Hong Kong", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Department of Clinical Oncology, Prince of Wales Hospital", "LocationCity":"Hong Kong", "LocationCountry":"Hong Kong" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000020123", "InterventionMeshTerm":"Sirolimus" },{ "InterventionMeshId":"D000017239", "InterventionMeshTerm":"Paclitaxel" },{ "InterventionMeshId":"D000016190", "InterventionMeshTerm":"Carboplatin" },{ "InterventionMeshId":"D000068338", "InterventionMeshTerm":"Everolimus" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000972", "InterventionAncestorTerm":"Antineoplastic Agents, Phytogenic" },{ "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000050257", "InterventionAncestorTerm":"Tubulin Modulators" },{ "InterventionAncestorId":"D000050256", "InterventionAncestorTerm":"Antimitotic Agents" },{ "InterventionAncestorId":"D000050258", "InterventionAncestorTerm":"Mitosis Modulators" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000007166", "InterventionAncestorTerm":"Immunosuppressive Agents" },{ "InterventionAncestorId":"D000007155", "InterventionAncestorTerm":"Immunologic Factors" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000900", "InterventionAncestorTerm":"Anti-Bacterial Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" },{ "InterventionAncestorId":"D000000903", "InterventionAncestorTerm":"Antibiotics, Antineoplastic" },{ "InterventionAncestorId":"D000000935", "InterventionAncestorTerm":"Antifungal Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M18120", "InterventionBrowseLeafName":"Paclitaxel", "InterventionBrowseLeafAsFound":"Paclitaxel", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M255", "InterventionBrowseLeafName":"Everolimus", "InterventionBrowseLeafAsFound":"RAD001", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M17233", "InterventionBrowseLeafName":"Carboplatin", "InterventionBrowseLeafAsFound":"Carboplatin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M20544", "InterventionBrowseLeafName":"Sirolimus", "InterventionBrowseLeafAsFound":"RAD001", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M231", "InterventionBrowseLeafName":"Albumin-Bound Paclitaxel", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24784", "InterventionBrowseLeafName":"Tubulin Modulators", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24783", "InterventionBrowseLeafName":"Antimitotic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8795", "InterventionBrowseLeafName":"Immunosuppressive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8784", "InterventionBrowseLeafName":"Immunologic Factors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2803", "InterventionBrowseLeafName":"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2805", "InterventionBrowseLeafName":"Antibiotics, Antitubercular", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2835", "InterventionBrowseLeafName":"Antifungal Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M4835", "InterventionBrowseLeafName":"Clotrimazole", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M10379", "InterventionBrowseLeafName":"Miconazole", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000013274", "ConditionMeshTerm":"Stomach Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000005770", "ConditionAncestorTerm":"Gastrointestinal Neoplasms" },{ "ConditionAncestorId":"D000004067", "ConditionAncestorTerm":"Digestive System Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" },{ "ConditionAncestorId":"D000005767", "ConditionAncestorTerm":"Gastrointestinal Diseases" },{ "ConditionAncestorId":"D000013272", "ConditionAncestorTerm":"Stomach Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M14647", "ConditionBrowseLeafName":"Stomach Neoplasms", "ConditionBrowseLeafAsFound":"Gastric Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M2166", "ConditionBrowseLeafName":"Adenocarcinoma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7469", "ConditionBrowseLeafName":"Gastrointestinal Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5839", "ConditionBrowseLeafName":"Digestive System Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14645", "ConditionBrowseLeafName":"Stomach Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T5511", "ConditionBrowseLeafName":"Stomach Cancer", "ConditionBrowseLeafAsFound":"Gastric Cancer", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }