2022
A phase II study of sapanisertib (TAK-228) a mTORC1/2 inhibitor in rapalog-resistant advanced pancreatic neuroendocrine tumors (PNET): ECOG-ACRIN EA2161
Rajdev L, Lee JW, Libutti SK, Benson AB, Fisher GA, Kunz PL, Hendifar AE, Catalano P, O’Dwyer P. A phase II study of sapanisertib (TAK-228) a mTORC1/2 inhibitor in rapalog-resistant advanced pancreatic neuroendocrine tumors (PNET): ECOG-ACRIN EA2161. Investigational New Drugs 2022, 40: 1306-1314. PMID: 36264382, PMCID: PMC9795724, DOI: 10.1007/s10637-022-01311-w.Peer-Reviewed Original ResearchConceptsPancreatic neuroendocrine tumorsNeuroendocrine tumorsTreatment-related grade 3 adverse eventsGrade 3 adverse eventsAdvanced pancreatic neuroendocrine tumorsTwo-stage phase II trialObjective tumor responsePhase II studyPhase II trialContinuous dosing scheduleStage 1Lack of responseEligible patientsMedian OSMedian PFSII trialAdverse eventsII studyObjective responseDosing schedulesTumor responseClinical activityPatientsMTOR pathwayMTORC1/2 inhibitorsCorrection: Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer
Shah MA, Wainberg ZA, Catenacci DVT, Hochster HS, Ford J, Kunz P, Lee FC, Kallender H, Cecchi F, Rabe DC, Keer H, Martin AM, Liu Y, Gagnon R, Bonate P, Liu L, Gilmer T, Bottaro DP. Correction: Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer. PLOS ONE 2022, 17: e0276211. PMID: 36215283, PMCID: PMC9550092, DOI: 10.1371/journal.pone.0276211.Peer-Reviewed Original ResearchEverolimus with or without bevacizumab in advanced pNET: CALGB 80701 (Alliance).
Kulke MH, Ou FS, Niedzwiecki D, Huebner L, Kunz P, Kennecke HF, Wolin EM, Chan JA, O'Reilly EM, Meyerhardt JA, Venook A. Everolimus with or without bevacizumab in advanced pNET: CALGB 80701 (Alliance). Endocrine Related Cancer 2022, 29: 335-344. PMID: 35324465, PMCID: PMC9257687, DOI: 10.1530/erc-21-0239.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic neuroendocrine tumorsProgression-free survivalPancreatic neuroendocrine tumorsVEGF pathway inhibitorsCombination armPrimary endpointMedian overall survival durationTreatment-related adverse eventsImproved progression-free survivalRandomized phase II studySuperior progression-free survivalPathway inhibitorOverall survival durationPhase II studyTreatment-related toxicityCombination of everolimusMTOR inhibitor everolimusHigh response rateAdverse eventsII studyInvestigator reviewCombination therapyStandard doseInhibitor everolimusNeuroendocrine tumors
2021
Correction: Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer
Shah MA, Wainberg ZA, Catenacci DVT, Hochster HS, Ford J, Kunz P, Lee FC, Kallender H, Cecchi F, Rabe DC, Keer H, Martin AM, Liu Y, Gagnon R, Bonate P, Liu L, Gilmer T, Bottaro DP. Correction: Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer. PLOS ONE 2021, 16: e0261994. PMID: 34941969, PMCID: PMC8699912, DOI: 10.1371/journal.pone.0261994.Peer-Reviewed Original Research
2018
Phase II study of epacadostat with pembrolizumab in metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma requiring paired biopsies.
Kardosh A, Tseng D, Sahaf B, Zomet A, Krupa J, Fisher G, Wang D, Mackall C, Kunz P. Phase II study of epacadostat with pembrolizumab in metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma requiring paired biopsies. Journal Of Clinical Oncology 2018, 36: tps191-tps191. DOI: 10.1200/jco.2018.36.4_suppl.tps191.Peer-Reviewed Original ResearchProgression-free survivalGastroesophageal junctionOverall survivalResponse rateGastric adenocarcinomaECOG performance status 0Phase II clinical trialPDL-1 expressionPerformance status 0Single-agent pembrolizumabMedian overall survivalPD-1 inhibitorsPhase II studyIncidence of adenocarcinomaGastroesophageal junction adenocarcinomaComprehensive immune profilingMajor health problemCombination immunotherapyEligible patientsKEYNOTE-059PFS ratesPrior therapyPrior trastuzumabStatus 0Advanced disease
2016
Oxaliplatin–Fluoropyrimidine Chemotherapy Plus Bevacizumab in Advanced Neuroendocrine Tumors
Kunz PL, Balise RR, Fehrenbacher L, Pan M, Venook AP, Fisher GA, Tempero MA, Ko AH, Korn WM, Hwang J, Bergsland EK. Oxaliplatin–Fluoropyrimidine Chemotherapy Plus Bevacizumab in Advanced Neuroendocrine Tumors. Pancreas 2016, 45: 1394-1400. PMID: 27171514, DOI: 10.1097/mpa.0000000000000659.Peer-Reviewed Original ResearchConceptsRadiographic response rateAdvanced neuroendocrine tumorsPrimary end pointProgression-free survivalNeuroendocrine tumorsPancreatic neuroendocrine tumorsNeuroendocrine carcinomaProspective phase II studyB studyEnd pointProlonged disease stabilityPhase II studyEffectiveness of bevacizumabDifferentiated neuroendocrine carcinomaPredictable toxicityRR-18Maintenance therapyDisease stabilityII studyRadiographic responsePatientsResponse rateNET subtypesBevacizumabMonths
2015
Randomized phase II study of everolimus (E) versus everolimus plus bevacizumab (E+B) in patients (Pts) with locally advanced or metastatic pancreatic neuroendocrine tumors (pNET), CALGB 80701 (Alliance).
Kulke M, Niedzwiecki D, Foster N, Fruth B, Kunz P, Kennecke H, Wolin E, Venook A. Randomized phase II study of everolimus (E) versus everolimus plus bevacizumab (E+B) in patients (Pts) with locally advanced or metastatic pancreatic neuroendocrine tumors (pNET), CALGB 80701 (Alliance). Journal Of Clinical Oncology 2015, 33: 4005-4005. DOI: 10.1200/jco.2015.33.15_suppl.4005.Peer-Reviewed Original Research
2014
Phase II clinical trial of pasireotide long-acting repeatable in patients with metastatic neuroendocrine tumors
Cives M, Kunz P, Morse B, Coppola D, Schell M, Campos T, Nguyen P, Nandoskar P, Khandelwal V, Strosberg J. Phase II clinical trial of pasireotide long-acting repeatable in patients with metastatic neuroendocrine tumors. Endocrine Related Cancer 2014, 22: 1-9. PMID: 25376618, PMCID: PMC4643672, DOI: 10.1530/erc-14-0360.Peer-Reviewed Original ResearchConceptsProgression-free survivalOverall radiographic response rateOverall survivalPasireotide LARSomatostatin analoguesFirst-line systemic agentMedian progression-free survivalPhase II clinical trialGrade 3 hyperglycemiaMetastatic grade 1Neuroendocrine tumor growthPrevious systemic therapyRadiographic response rateRates of hyperglycemiaGrade 3/4 toxicitiesMedian overall survivalMetastatic neuroendocrine tumorsPhase II studySolid Tumors criteriaTreatment-naïve patientsHepatic tumor burdenResponse Evaluation CriteriaNovel somatostatin analogReceptor subtype 1LAR treatmentA phase II study of capecitabine, carboplatin, and bevacizumab for metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma.
Kunz P, Nandoskar P, Koontz M, Ji H, Ford J, Balise R, Kamaya A, Rubin D, Fisher G. A phase II study of capecitabine, carboplatin, and bevacizumab for metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma. Journal Of Clinical Oncology 2014, 32: 115-115. DOI: 10.1200/jco.2014.32.3_suppl.115.Peer-Reviewed Original ResearchProgression-free survivalGastroesophageal junctionStable diseaseOverall survivalPartial responseGastric adenocarcinomaPrimary endpointProgressive diseaseDay 1Response rateMedian progression-free survivalCombination of capecitabineFirst tumor assessmentBest supportive careMedian overall survivalPhase II studyPromising response ratesAddition of bevacizumabIncidence of adenocarcinomaMajor health problemQuality of lifeSecondary endpointsBaseline characteristicsFree survivalGastric cardia
2013
Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer
Shah MA, Wainberg ZA, Catenacci DV, Hochster HS, Ford J, Kunz P, Lee FC, Kallender H, Cecchi F, Rabe DC, Keer H, Martin AM, Liu Y, Gagnon R, Bonate P, Liu L, Gilmer T, Bottaro DP. Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer. PLOS ONE 2013, 8: e54014. PMID: 23516391, PMCID: PMC3597709, DOI: 10.1371/journal.pone.0054014.Peer-Reviewed Original ResearchConceptsObjective response rateMetastatic gastric cancerStable diseaseMET amplificationPhospho-METGastric adenocarcinomaIntermittent dosingGastric cancerTreatment-related adverse eventsPhase II studyMetastatic gastric adenocarcinomaRates of hypertensionElevated aspartate aminotransferaseOral multikinase inhibitorEndothelial cell growth factorVascular endothelial cell growth factorCell growth factorEvaluable patientsForetinib treatmentPrior therapyAdverse eventsII studyUnselected patientsDosing schedulesMedian age
2010
A phase II study of capecitabine, oxaliplatin, and bevacizumab for metastatic or unresectable neuroendocrine tumors.
Kunz P, Kuo T, Zahn J, Kaiser H, Norton J, Visser B, Longacre T, Ford J, Balise R, Fisher G. A phase II study of capecitabine, oxaliplatin, and bevacizumab for metastatic or unresectable neuroendocrine tumors. Journal Of Clinical Oncology 2010, 28: 4104-4104. DOI: 10.1200/jco.2010.28.15_suppl.4104.Peer-Reviewed Original Research
2009
Assessment of two dosing schedules of GSK1363089 (GSK089), a dual MET/VEGFR2 inhibitor, in metastatic gastric cancer (GC): Interim results of a multicenter phase II study
Jhawer M, Kindler H, Wainberg Z, Ford J, Kunz P, Tang L, McCallum S, Kallender H, Shah M. Assessment of two dosing schedules of GSK1363089 (GSK089), a dual MET/VEGFR2 inhibitor, in metastatic gastric cancer (GC): Interim results of a multicenter phase II study. Journal Of Clinical Oncology 2009, 27: 4502-4502. DOI: 10.1200/jco.2009.27.15_suppl.4502.Peer-Reviewed Original ResearchMetastatic gastric cancerPhase II studyGastric cancerStable diseaseAdverse eventsCMET amplificationEvaluable ptsII studyDosing schedulesGrade 5 adverse eventsMulticenter phase II studyAdequate organ functionECOG PS 0Prior chemotherapy regimensTreatment tumor biopsiesAntitumor activityDaily dosing schedulePrimary study endpointMinimal antitumor activityAttractive therapeutic targetCMET pathwayLFT abnormalitiesMeasurable diseaseTreatment biopsiesChemotherapy regimens
2008
A phase II study of capecitabine, oxaliplatin, and bevacizumab for metastatic or unresectable neuroendocrine tumors: Preliminary results
Kunz P, Kuo T, Kaiser H, Norton J, Longacre T, Ford J, Fisher G. A phase II study of capecitabine, oxaliplatin, and bevacizumab for metastatic or unresectable neuroendocrine tumors: Preliminary results. Journal Of Clinical Oncology 2008, 26: 15502-15502. DOI: 10.1200/jco.2008.26.15_suppl.15502.Peer-Reviewed Original Research