{ "FullStudy":{ "Rank":218266, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510561", "OrgStudyIdInfo":{ "OrgStudyId":"IM-T-hPAM4-03" }, "Organization":{ "OrgFullName":"Immunomedics, Inc.", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.", "OfficialTitle":"A Ph Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies." }, "StatusModule":{ "StatusVerifiedDate":"February 2015", "OverallStatus":"Unknown status", "LastKnownStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2015", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"September 2015", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 5, 2012", "StudyFirstSubmitQCDate":"January 11, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 16, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 12, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 16, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Immunomedics, Inc.", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"90Y-hPAM4 is administered weekly for 3 weeks combined with 4 weekly doses of gemcitabine to assess. This is a dose escalation study of 90Y-hPAM4 to assess which dose is safe and effective as 3rd line treatment for patients with metastatic pancreatic cancer. Patients are then followed weekly for 12 weeks and afterwards for up to 1 year." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Metastatic Pancreatic Adenocarcinoma", "Pancreatic Cancer", "Metastatic Pancreatic Cancer" ] }, "KeywordList":{ "Keyword":[ "metastatic pancreatic adenocarcinoma", "pancreatic cancer", "metastatic pancreatic cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"50", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"90Y-hPAM4", "ArmGroupType":"Experimental", "ArmGroupDescription":"90Y-hPAM4 is administered weekly for 3 weeks", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: 90Y-hPAM4" ] } },{ "ArmGroupLabel":"90Y-hPAM4 + gemcitabine", "ArmGroupType":"Experimental", "ArmGroupDescription":"90Y-hPAM4 is administered weekly for 3 weeks, while gemcitabine is administered weekly for 4 weeks.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: 90Y-hPAM4", "Drug: 90Y-hPAM4 + gemcitabine" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"90Y-hPAM4", "InterventionDescription":"90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "90Y-hPAM4", "90Y-hPAM4 + gemcitabine" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Clivatuzumab Tetraxetan" ] } },{ "InterventionType":"Drug", "InterventionName":"90Y-hPAM4", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "90Y-hPAM4", "90Y-hPAM4 + gemcitabine" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "clivatuzumab tetraxetan" ] } },{ "InterventionType":"Drug", "InterventionName":"90Y-hPAM4 + gemcitabine", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "90Y-hPAM4 + gemcitabine" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "gemzar", "clivatuzumab tetraxetan" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Safety (change in hematology and chemistry laboratory values from baseline)", "PrimaryOutcomeDescription":"Acute safety will be assessed weekly for the 1st 12 weeks, and then for up to 1 year after completion of study drug treatment. Safety will be assessed by comparing baseline hematology and chemistry laboratory values with the values obtained weekly after treatment. Safety will also be assessed by the adverse events that are reported.", "PrimaryOutcomeTimeFrame":"1 year" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Dosage determination", "SecondaryOutcomeDescription":"This study is also being done to determine an acceptable 90Y-hPAM4 dose in this patient population. It is anticipated that enrollment will occur over 2 years.", "SecondaryOutcomeTimeFrame":"2 years" },{ "SecondaryOutcomeMeasure":"Efficacy", "SecondaryOutcomeDescription":"Efficacy will be assessed for at least 1 year after treatment with study drug. CT scans will be used to determine treatment response.", "SecondaryOutcomeTimeFrame":"1 year" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale or female patients, ≥ 18 years of age, who are able to understand and give written informed consent\nHistologically or cytologically confirmed pancreatic adenocarcinoma\nStage IV (metastatic) disease, including patients who underwent surgery but had incomplete resections\nPreviously treated and received two prior treatment regimens for advanced disease\nKarnofsky performance status ≥ 60 % (Appendix A)\nExpected survival ≥ 3 months\nAt least 4 weeks beyond major surgery, 2 weeks beyond chemotherapy, radiotherapy, other experimental treatments\nAt least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis\nAdequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3)\nAdequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and ALT ≤ 2.0 X IULN [5.0 X IULN if due to liver metastases])\nOtherwise, all toxicity at study entry ≤ Grade 1 by NCI CTC v3.0 or recovered to baseline or discussed with and agreed to with Immunomedics' Medical Monitor.\n\nExclusion Criteria:\n\nWomen who are pregnant or lactating\nWomen of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period\nKnown metastatic disease to the central nervous system\nPresence of bulky disease (defined as any single mass > 10 cm in its greatest dimension)\nPatients with > Grade 2 nausea or vomiting and/or signs of intestinal obstruction\nPrior radiation dose > 3,000 cGy to the liver, > 2,000 cGy to lungs and kidneys or prior external beam irradiation to a field that includes more than 30% of the red marrow\nPatients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 3-year disease free interval\nPatients known to be HIV positive, hepatitis B positive, or hepatitis C positive\nKnown history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months, or cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy\nKnown history of active COPD, or other moderate-to-severe respiratory illness present within 6 months\nKnown autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids)\nInfection requiring intravenous antibiotic use within 1 week\nOther concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"William A Wegener, MD, PhD", "OverallOfficialAffiliation":"Immunomedics, Inc.", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Banner Healthcare", "LocationCity":"Gilbert", "LocationState":"Arizona", "LocationZip":"85234", "LocationCountry":"United States" },{ "LocationFacility":"Scottsdale Healthcare", "LocationCity":"Scottsdale", "LocationState":"Arizona", "LocationZip":"85258", "LocationCountry":"United States" },{ "LocationFacility":"Christiana Care Health Services Helen Graham Cancer Center", "LocationCity":"Newark", "LocationState":"Delaware", "LocationZip":"19713", "LocationCountry":"United States" },{ "LocationFacility":"Sylvester Comprehensive Cancer Center Univ. Miami", "LocationCity":"Miami", "LocationState":"Florida", "LocationZip":"33136", "LocationCountry":"United States" },{ "LocationFacility":"Jackson North Medical Center", "LocationCity":"Miami", "LocationState":"Florida", "LocationZip":"33169", "LocationCountry":"United States" },{ "LocationFacility":"Moffitt Cancer Center", "LocationCity":"Tampa", "LocationState":"Florida", "LocationZip":"33612", "LocationCountry":"United States" },{ "LocationFacility":"Winship Cancer Institute", "LocationCity":"Atlanta", "LocationState":"Georgia", "LocationZip":"30308", "LocationCountry":"United States" },{ "LocationFacility":"Mountain States Tumor Institute", "LocationCity":"Boise", "LocationState":"Idaho", "LocationZip":"83712", "LocationCountry":"United States" },{ "LocationFacility":"Goshen Center for Cancer Care", "LocationCity":"Goshen", "LocationState":"Indiana", "LocationZip":"46526", "LocationCountry":"United States" },{ "LocationFacility":"Detroit Clinical Research Center", "LocationCity":"Detroit", "LocationState":"Michigan", "LocationZip":"48377", "LocationCountry":"United States" },{ "LocationFacility":"St. Mary's Trinity Healthcare", "LocationCity":"Grand Rapids", "LocationState":"Michigan", "LocationZip":"49503", "LocationCountry":"United States" },{ "LocationFacility":"New Mexico Cancer Care Alliance", "LocationCity":"Albuquerque", "LocationState":"New Mexico", "LocationZip":"87131", "LocationCountry":"United States" },{ "LocationFacility":"Weill Cornell NY Presbyterian Hospital", "LocationCity":"New York", "LocationState":"New York", "LocationZip":"10021", "LocationCountry":"United States" },{ "LocationFacility":"Mt. Sinai Medical Center", "LocationCity":"New York", "LocationState":"New York", "LocationZip":"10029", "LocationCountry":"United States" },{ "LocationFacility":"Memorial Sloan Kettering Cancer Center", "LocationCity":"New York", "LocationState":"New York", "LocationZip":"10065", "LocationCountry":"United States" },{ "LocationFacility":"University of North Carolina Medical Center", "LocationCity":"Chapel Hill", "LocationState":"North Carolina", "LocationZip":"27599", "LocationCountry":"United States" },{ "LocationFacility":"Ohio State University Medical Center", "LocationCity":"Columbus", "LocationState":"Ohio", "LocationZip":"43210", "LocationCountry":"United States" },{ "LocationFacility":"Kimmel Cancer Center at Jefferson University", "LocationCity":"Philadelphia", "LocationState":"Pennsylvania", "LocationZip":"19107", "LocationCountry":"United States" },{ "LocationFacility":"Fox Chase Cancer Center", "LocationCity":"Philadelphia", "LocationState":"Pennsylvania", "LocationZip":"19111", "LocationCountry":"United States" },{ "LocationFacility":"Hillman Cancer Center", "LocationCity":"Pittsburgh", "LocationState":"Pennsylvania", "LocationZip":"15232", "LocationCountry":"United States" },{ "LocationFacility":"Institute of Translational Oncology Research", "LocationCity":"Greenville", "LocationState":"South Carolina", "LocationZip":"29605", "LocationCountry":"United States" },{ "LocationFacility":"Tyler Cancer Center", "LocationCity":"Tyler", "LocationState":"Texas", "LocationZip":"75702", "LocationCountry":"United States" },{ "LocationFacility":"VA Oncology Associates", "LocationCity":"Norfolk", "LocationState":"Virginia", "LocationZip":"23502", "LocationCountry":"United States" },{ "LocationFacility":"Virginia Mason Medical Center", "LocationCity":"Seattle", "LocationState":"Washington", "LocationZip":"98111", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"26187510", "ReferenceType":"derived", "ReferenceCitation":"Picozzi VJ, Ramanathan RK, Lowery MA, Ocean AJ, Mitchel EP, O'Neil BH, Guarino MJ, Conkling PR, Cohen SJ, Bahary N, Frank RC, Dragovich T, Bridges BB, Braiteh FS, Starodub AN, Lee FC, Gribbin TE, Richards DA, Lee M, Korn RL, Pandit-Taskar N, Goldsmith SJ, Intenzo CM, Sheikh A, Manzone TC, Horne H, Sharkey RM, Wegener WA, O'Reilly EM, Goldenberg DM, Von Hoff DD. (90)Y-clivatuzumab tetraxetan with or without low-dose gemcitabine: A phase Ib study in patients with metastatic pancreatic cancer after two or more prior therapies. Eur J Cancer. 2015 Sep;51(14):1857-64. doi: 10.1016/j.ejca.2015.06.119. Epub 2015 Jul 14." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"C000056507", "InterventionMeshTerm":"Gemcitabine" },{ "InterventionMeshId":"D000000911", "InterventionMeshTerm":"Antibodies, Monoclonal" },{ "InterventionMeshId":"C000071349", "InterventionMeshTerm":"1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000964", "InterventionAncestorTerm":"Antimetabolites, Antineoplastic" },{ "InterventionAncestorId":"D000000963", "InterventionAncestorTerm":"Antimetabolites" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000000998", 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