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
2006
Pharmacokinetic and safety study of weekly irinotecan and oral capecitabine in patients with advanced solid cancers
Goel S, Desai K, Karri S, Gollamudi R, Chaudhary I, Bulgaru A, Kaubisch A, Goldberg G, Einstein M, Camacho F, Baker S, Mani S. Pharmacokinetic and safety study of weekly irinotecan and oral capecitabine in patients with advanced solid cancers. Investigational New Drugs 2006, 25: 237-245. PMID: 17195945, DOI: 10.1007/s10637-006-9028-1.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsArea Under CurveCamptothecinCapecitabineCarboxylesteraseDeoxycytidineDose-Response Relationship, DrugDrug Administration ScheduleDrug InteractionsFemaleFluorouracilHumansInfusions, IntravenousIrinotecanMaleMiddle AgedNeoplasmsNeutropeniaTreatment OutcomeConceptsDrug-drug interactionsDay 1Day 8Open-label phase ISN-38Potential drug-drug interactionsConversion of irinotecanGrade 3 diarrheaCycles of chemotherapyAdvanced solid cancersAdvanced solid tumorsDose level 5Diarrhea/vomitingWarrants further evaluationSynergistic anti-cancer activitySN-38GWarrants further studyFatal neutropeniaOral capecitabineAnti-cancer activityDose cohortsEvaluable patientsEscalation trialNegative sepsisMin infusion
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 investigationDoseA safety study of a mixed-backbone oligonucleotide (GEM231) targeting the type I regulatory subunit alpha of protein kinase A using a continuous infusion schedule in patients with refractory solid tumors.
Goel S, Desai K, Bulgaru A, Fields A, Goldberg G, Agrawal S, Martin R, Grindel M, Mani S. A safety study of a mixed-backbone oligonucleotide (GEM231) targeting the type I regulatory subunit alpha of protein kinase A using a continuous infusion schedule in patients with refractory solid tumors. Clinical Cancer Research 2003, 9: 4069-76. PMID: 14519628.Peer-Reviewed Original Research