{ "FullStudy":{ "Rank":217854, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515969", "OrgStudyIdInfo":{ "OrgStudyId":"IRB-21659" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"IRB-18952", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Stanford IRB (withdrawn study number)" },{ "SecondaryId":"LUN0044", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"OnCore" },{ "SecondaryId":"NCI-2011-03333", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"CTRP (Clinical Trial Reporting Program)" },{ "SecondaryId":"SU-08012011-8166", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Stanford University" } ] }, "Organization":{ "OrgFullName":"Stanford University", "OrgClass":"OTHER" }, "BriefTitle":"Phase 1 Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer (NSCLC)", "OfficialTitle":"A Phase I Study of Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer" }, "StatusModule":{ "StatusVerifiedDate":"July 2016", "OverallStatus":"Terminated", "WhyStopped":"Patient safety - Unacceptable toxicity", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"July 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 16, 2011", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 11, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 12, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor-Investigator", "ResponsiblePartyInvestigatorFullName":"Heather Wakelee", "ResponsiblePartyInvestigatorTitle":"Assistant Professor of Medicine", "ResponsiblePartyInvestigatorAffiliation":"Stanford University" }, "LeadSponsor":{ "LeadSponsorName":"Heather Wakelee", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Genentech, Inc.", "CollaboratorClass":"INDUSTRY" },{ "CollaboratorName":"Novartis", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This phase I trial studies the side effects and best dose of giving erlotinib and dovitinib together to treat patients with metastatic non-small cell lung cancer. Erlotinib blocks the epidermal growth factor receptor (EGFR) and has known activity in non-small cell lung cancer and dovitinib blocks the fibroblast growth factor receptor (FGFR) and other targets which may be important to treat lung cancer. The combination of both drugs may work better than either drug alone, but may also have increased side effects. This trial will look at the side effects of combining the drugs and look for how effective the combination may be.", "DetailedDescription":"PRIMARY OBJECTIVES:\n\nI. To characterize the safety and tolerability of the combination of erlotinib (erlotinib hydrochloride) and dovitinib (dovitinib lactate), assessing for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.\n\nII. To determine the maximum tolerated dose (MTD) of the combination of erlotinib and dovitinib.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate overall response rate (ORR), progression free survival (PFS), and overall survival (OS) of patients receiving the combination of erlotinib and dovitinib, although this phase will allow for patients who received any number of prior treatments, including prior treatment with erlotinib.\n\nII. To evaluate the potential impact of dovitinib on erlotinib pharmacokinetics (PK).\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive erlotinib hydrochloride orally (PO) once daily (QD). Starting on day 15, patients also receive dovitinib lactate PO QD on days 1-5 of each week. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up for 12 months." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Non-small Cell Lung Cancer (NSCLC), Recurrent", "Non-small Cell Lung Cancer (NSCLC), Stage IV" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"9", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Treatment (enzyme inhibitor therapy)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Patients receive erlotinib hydrochloride PO QD. Starting on day 15, patients also receive dovitinib lactate PO QD on days 1-5 of each week. Treatment continues in the absence of disease progression or unacceptable toxicity.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Erlotinib hydrochloride", "Drug: Dovitinib lactate" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Erlotinib hydrochloride", "InterventionDescription":"Given PO", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Treatment (enzyme inhibitor therapy)" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Erlotinib HCl", "Tarceva", "CP-358,774", "OSI-774" ] } },{ "InterventionType":"Drug", "InterventionName":"Dovitinib lactate", "InterventionDescription":"Given PO", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Treatment (enzyme inhibitor therapy)" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "CHIR-258", "Receptor tyrosine kinase (RTK) inhibitor TKI258", "TKI258" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Measure toxicity to determine the MTD of the combination of erlotinib hydrochloride and dovitinib lactate", "PrimaryOutcomeDescription":"Dose limiting toxicity (DLT) is defined as a CTCAE v4.0 toxicity >= grade 3 or 4 occurring after 3 weeks of treatment. If 2 of 6 patients experience a DLT, then the MTD will be defined as the dose tolerated by the cohort preceding the cohort experiencing the DLT.", "PrimaryOutcomeTimeFrame":"1 year" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"ORR (complete response [CR]+ partial response [PR])", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"PFS", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"OS", "SecondaryOutcomeTimeFrame":"1 year" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHistologically-confirmed metastatic non-small cell lung cancer\nOne or more primary or metastatic lesions measurable in at least one dimension by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria (v1.1) within 4 weeks prior to entry of study\nPatients who have failed any number of prior therapies, including those previously treated with erlotinib\nLife expectancy > 2 months\nEastern Cooperative Oncology Group (ECOG) performance status 0-2\nAbsolute neutrophil count (ANC) >= 1.5 x 10^9/L (>= 1500/mm^3)\nPlatelets (PLT) >= 100,000/mm^3\nHemoglobin (Hgb) >= 9 g/dL\nSerum creatinine =< 1.5 x upper limit of normal (ULN)\nSerum bilirubin =< 1.5 x ULN (regardless of whether liver metastases are present at baseline)\nAspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) =< 3.0 x ULN (regardless of whether liver metastases are present at baseline)\nAbility to understand and the willingness to provide verbal and written informed consent\nPatients - both males and females- with reproductive potential (i.e. menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study; women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration\n\nExclusion Criteria:\n\nPatients who have received the last administration of chemotherapy or immunotherapy =< the timeframe defined below after the end of the cycle of the last treatment, prior to starting study drug, or who have not recovered from the side effects of such therapy:\n\nPatients who have received the last administration of chemotherapy/immunotherapy in a daily schedule =< 7 days prior to starting study drug\nPatients who have received the last administration of chemotherapy/immunotherapy in a weekly schedule =< 2 weeks prior to starting study drug\nPatients who have received the last administration of chemotherapy/immunotherapy in a 2-weekly schedule =< 3 weeks prior to starting study drug\nPatients who have received the last administration of chemotherapy/immunotherapy in a 3-weekly schedule =< 4 weeks prior to starting study drug\nPatients who have received the last administration of chemotherapy/immunotherapy in a 4-weekly schedule =< 5 weeks prior to starting study drug\nPatients who have received the last administration of nitrosourea, mitomycin-C =< 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy\nPatients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy\nPatients who have undergone major surgery =< 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy\n\nIf history of other primary cancer, subject will be eligible only if she or he has:\n\nCuratively resected non-melanomatous skin cancer, basal cell carcinoma, squamous cell carcinoma\nCuratively treated cervical carcinoma in situ\nOther primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years\nSubjects known to have chronic or active hepatitis B or C infection with impaired hepatic function (ineligible if AST and ALT > 2.5 x ULN)\nHistory of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results\nPatients who continue to smoke (given that smoking decreases serum levels of erlotinib)\nFemale subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to enrollment\n\nAny of the following concurrent severe and/or uncontrolled medical conditions within 6 months of enrollment which could compromise participation in the study:\n\nUnstable angina pectoris\nUncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without anti-hypertensive medication; initiation or adjustment of antihypertensive medication(s) is allowed prior to study entry\nLeft ventricular ejection fraction (LVEF) assessed by 2-D echocardiogram (ECHO) < 50% or lower limit of normal (whichever is higher) or multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (whichever is higher)\nMyocardial infarction\nSerious uncontrolled ventricular arrhythmia\nClinically significant resting bradycardia\nUncontrolled diabetes\nTransient Ischemic Attach (TIA)\nCerebrovascular accident (CVA)\nPulmonary embolism (PE)\nImpairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\nSerious active or uncontrolled infection\nInterstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung\nChronic renal disease\nCirrhosis, chronic active hepatitis or chronic persistent hepatitis\nPatients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin or enoxaparin\nWomen of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception; highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 8 weeks after the end of study treatment; oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 14 days prior to starting study treatment\nPatients unwilling to or unable to comply with the protocol\nThere may be danger of harm to study participants because of human immunodeficiency virus (HIV) comorbidity or drug interactions", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Heather Wakelee", "OverallOfficialAffiliation":"Stanford University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Stanford University", "LocationCity":"Stanford", "LocationState":"California", "LocationZip":"94305", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000069347", "InterventionMeshTerm":"Erlotinib Hydrochloride" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000047428", "InterventionAncestorTerm":"Protein Kinase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M398", "InterventionBrowseLeafName":"Erlotinib Hydrochloride", "InterventionBrowseLeafAsFound":"Erlotinib", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M24407", "InterventionBrowseLeafName":"Protein Kinase Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T22", "InterventionBrowseLeafName":"Tyrosine", "InterventionBrowseLeafAsFound":"Tyrosine", "InterventionBrowseLeafRelevance":"high" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"AA", "InterventionBrowseBranchName":"Amino Acids" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000008175", "ConditionMeshTerm":"Lung Neoplasms" },{ "ConditionMeshId":"D000002289", "ConditionMeshTerm":"Carcinoma, Non-Small-Cell Lung" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012142", "ConditionAncestorTerm":"Respiratory Tract Neoplasms" },{ "ConditionAncestorId":"D000013899", "ConditionAncestorTerm":"Thoracic Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" },{ "ConditionAncestorId":"D000002283", "ConditionAncestorTerm":"Carcinoma, Bronchogenic" },{ "ConditionAncestorId":"D000001984", "ConditionAncestorTerm":"Bronchial Neoplasms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M9755", "ConditionBrowseLeafName":"Lung Neoplasms", "ConditionBrowseLeafAsFound":"Lung Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4128", "ConditionBrowseLeafName":"Carcinoma, Non-Small-Cell Lung", "ConditionBrowseLeafAsFound":"Non-Small Cell Lung Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4116", "ConditionBrowseLeafName":"Carcinoma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13562", "ConditionBrowseLeafName":"Respiratory Tract Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15241", "ConditionBrowseLeafName":"Thoracic Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4122", "ConditionBrowseLeafName":"Carcinoma, Bronchogenic", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3842", "ConditionBrowseLeafName":"Bronchial Neoplasms", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }