2007
Pharmacokinetic and safety study of subcutaneously administered weekly ING-1, a human engineered™ monoclonal antibody targeting human EpCAM, in patients with advanced solid tumors
Goel S, Bauer R, Desai K, Bulgaru A, Iqbal T, Strachan B, Kim G, Kaubisch A, Vanhove G, Goldberg G, Mani S. Pharmacokinetic and safety study of subcutaneously administered weekly ING-1, a human engineered™ monoclonal antibody targeting human EpCAM, in patients with advanced solid tumors. Annals Of Oncology 2007, 18: 1704-1707. PMID: 17693421, DOI: 10.1093/annonc/mdm280.Peer-Reviewed Original ResearchConceptsING-1Human anti–human antibody (HAHA) responsesMonoclonal antibodiesGrade 3 pancreatitisAdvanced solid tumorsAdvanced refractory cancerPeak drug levelsRisk of pancreatitisAnti-tumor effectsStable diseaseMonotherapy studiesThird doseAntibody responseRefractory cancerMost adenocarcinomasDrug levelsPharmacokinetic samplesWeek 1Colon cancerPatientsSolid tumorsDrug accumulationCombination studiesFurther experienceSafety studies
2003
Phase I clinical study of infusional 5-fluorouracil with oxaliplatin and gemcitabine (FOG regimen) in patients with solid tumors
Goel S, Bulgaru A, Hochster H, Wadler S, Zamboni W, Egorin M, Ivy P, Leibes L, Muggia F, Lockwood G, Harvey E, Renshaw G, Mani S. Phase I clinical study of infusional 5-fluorouracil with oxaliplatin and gemcitabine (FOG regimen) in patients with solid tumors. Annals Of Oncology 2003, 14: 1682-1687. PMID: 14581279, DOI: 10.1093/annonc/mdg453.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityAdvanced solid tumorsSolid tumorsCycle 1Day 1Cycle 1 dose-limiting toxicitiesDose levelsPhase I clinical studyGrade 3 toxicityPhase II doseGemcitabine combinationNovel regimenPartial responseClinical studiesPatientsGemcitabineOxaliplatinRPTDTitration schemeTumorsDL-4RegimenCycle 2Further investigationDose