[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100202402":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":11,"locations":43,"responsibleParty":84,"collaborators":11,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":11,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":11,"enrollmentInfo":96,"targetDuration":11,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":110,"whyStopped":111,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"PF 03446962 plus best supportive care (BSC)","EXPERIMENTAL",null,[13,14],"Drug: PF-03446962","Other: Best Supportive Care",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo plus best supportive care (BSC)","PLACEBO_COMPARATOR","Placebo, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first",[20,14],"Other: Placebo",[22,27,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"DRUG","PF-03446962","PF 03446962 7 mg\u002Fkg, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"OTHER","Best Supportive Care","BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"Placebo","Placebo will consist of Saline (0.9% w\u002Fv Sodium Chloride Injection, USP or NS)",[16],{"type":28,"name":29,"description":37,"armGroupLabels":38,"otherNames":11},"BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.",[16],[40],{"name":41,"affiliation":5,"role":42},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[44,57,69,79],{"facility":45,"status":11,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":11},"Fox Chase Cancer Center","Philadelphia","Pennsylvania","19111","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-75.16362,39.95238,{"lat":55,"lon":54},{"facility":58,"status":11,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":11},"National Cancer Center Hospital East","Kashiwa","Chiba","277-8577","Japan","JP",{"type":52,"coordinates":65},[66,67],139.97732,35.86224,{"lat":67,"lon":66},{"facility":70,"status":11,"city":71,"state":72,"zip":73,"country":62,"countryCode":63,"cosmosGeoPoint":74,"geoPoint":78,"contacts":11},"Kinki University Hospital, Department of Gastroenterology and Hepatology","Ōsaka-sayama","Osaka","589-8511",{"type":52,"coordinates":75},[76,77],135.55069,34.49524,{"lat":77,"lon":76},{"facility":80,"status":11,"city":81,"state":82,"zip":83,"country":62,"countryCode":63,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"National Cancer Center Hospital","Chuo-ku","Tokyo","104-0045",{"type":85,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100202402","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-the-investigational-drug-pf-03446962-a-monoclonal-antibody-with-antiangiogenic-features-in-combination-with-best-supportive-care-versus-placebo-plus-best-supportive-care-in-patients-affected-by-recurrent-liver-cancer-100202402",true,"NCT01911273","A Study To Evaluate The Efficacy And Safety of The Investigational Drug PF-03446962 (A Monoclonal Antibody With Antiangiogenic Features) In Combination With Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients Affected By Recurrent Liver Cancer","A Phase 2, Randomized, Double Blind Study To Evaluate The Efficacy, Safety, Pharmacodynamics And Pharmacokinetics Of The Anti-alk-1 Monoclonal Antibody Pf-03446962 In Combination With Best Supportive Care Vs. Placebo Plus Best Supportive Care In Adult Patients With Advanced Hepatocellular Carcinoma Following Failure Of Sorafenib","Inclusion Criteria:\n\n* Diagnosis of locally advanced or metastatic liver cancer obtained by histology\u002Fcytology or by imaging\n* Documented progression on or after treatment with sorafenib, confirmed by the Investigator upon review of appropriate imaging documentation\n* Child Pugh Class A disease\n* ECOG \\[Eastern Cooperative Oncology Group\\] Performance Status (PS) 0 or 1\n* Mandatory tumor biopsy at study entry (pre-randomization, unless already collected after sorafenib progression but within 3 months of enrollment and no systemic anticancer therapies received)\n\nExclusion Criteria:\n\n* Prior systemic treatment for advanced liver cancer other than sorafenib-including therapy\n* Prior local therapy within 2 weeks of starting the study treatment\n* Presence of main portal vein invasion by liver cancer",false,"ALL","18 Years",{"count":97,"type":98},3,"ACTUAL","INTERVENTIONAL",[101],"PHASE2","The primary purpose of the study is to explore whether treatment with PF-03446962 and best supportive care is better than placebo plus best supportive care in prolonging survival of patients affected by recurrent liver cancer. In addition, the study will explore if adding PF-03446962 to best supportive care is safe, how PF-03446962 is metabolized, if there are patients' characteristics (biomarkers) that may predict response to PF-03446962, and if PF-03446962 has any effect on the patients' quality of life.",[104],"Carcinoma, Hepatocellular",[106,107,108,109],"Hepatocellular carcinoma","monoclonal antibody","ALK-1","best supportive care","TERMINATED","See termination reason in detailed description.","2015-10-06",{"date":114,"type":115},"2015-10-28","ESTIMATED",{"date":117,"type":11},"2013-10",{"date":119,"type":98},"2014-07",{"name":5,"class":6},4]