2017
O-019 Ramucirumab plus pembrolizumab in previously treated advanced or metastatic biliary tract cancer: A multi-disease phase 1 study
Arkenau H, Bendell J, Herbst R, Mi G, Jin J, Rege J, Ferry D, Chau I. O-019 Ramucirumab plus pembrolizumab in previously treated advanced or metastatic biliary tract cancer: A multi-disease phase 1 study. Annals Of Oncology 2017, 28: iii144-iii145. DOI: 10.1093/annonc/mdx262.018.Peer-Reviewed Original Research90PD Previously treated advanced NSCLC cohort from a multi-disease phase 1 study of ramucirumab (R) plus pembrolizumab (P): Efficacy and safety data
Herbst R, Martin-Liberal J, Calvo E, Isambert N, Bendell J, Cassier P, Jin J, Mi G, Rege J, Paz-Ares L. 90PD Previously treated advanced NSCLC cohort from a multi-disease phase 1 study of ramucirumab (R) plus pembrolizumab (P): Efficacy and safety data. Annals Of Oncology 2017, 28: ii32-ii33. DOI: 10.1093/annonc/mdx091.010.Peer-Reviewed Original ResearchInterim safety and clinical activity in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma from a multicohort phase 1 study of ramucirumab (R) plus pembrolizumab (P).
Chau I, Bendell J, Calvo E, Santana-Davila R, Rodon Ahnert J, Penel N, Arkenau H, Yang J, Rege J, Mi G, Ferry D, Herbst R, Fuchs C. Interim safety and clinical activity in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma from a multicohort phase 1 study of ramucirumab (R) plus pembrolizumab (P). Journal Of Clinical Oncology 2017, 35: 102-102. DOI: 10.1200/jco.2017.35.4_suppl.102.Peer-Reviewed Original ResearchTreatment-related AEsCohort APD-L1GEJ adenocarcinomaPhase 1a/b trialECOG PS 0Treatment-related deathsDisease control rateNew safety signalsPhase 1 studyGastroesophageal junction adenocarcinomaBaseline tumor tissuePreliminary efficacy dataECOG PSMeasurable diseaseMedian PFSAdvanced gastricMaculopapular rashMedian durationPS 0Systemic therapyCohort BJunction adenocarcinomaMedian agePrior progression
2016
LBA38 Interim safety and clinical activity in patients with advanced NSCLC from a multi-cohort phase 1 study of ramucirumab (R) plus pembrolizumab (P)
Herbst R, Martin-Liberal J, Calvo E, Isambert N, Bendell J, Cassier P, Perez-Gracia J, Yang J, Rege J, Mi G, Ferry D, Paz-Ares L. LBA38 Interim safety and clinical activity in patients with advanced NSCLC from a multi-cohort phase 1 study of ramucirumab (R) plus pembrolizumab (P). Annals Of Oncology 2016, 27: vi574. DOI: 10.1093/annonc/mdw435.34.Peer-Reviewed Original ResearchA phase 1 study of ramucirumab (R) plus pembrolizumab (P) in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or urothelial carcinoma (UC): Phase 1a results.
Herbst R, Bendell J, Isambert N, Calvo E, Santana-Davila R, Cassier P, Perez-Gracia J, Yang J, Rege J, Ferry D, Mi G, Chau I. A phase 1 study of ramucirumab (R) plus pembrolizumab (P) in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or urothelial carcinoma (UC): Phase 1a results. Journal Of Clinical Oncology 2016, 34: 3056-3056. DOI: 10.1200/jco.2016.34.15_suppl.3056.Peer-Reviewed Original Research
2009
The changing face of Phase 1 cancer clinical trials
Craft BS, Kurzrock R, Lei X, Herbst R, Lippman S, Fu S, Karp DD. The changing face of Phase 1 cancer clinical trials. Cancer 2009, 115: 1592-1597. PMID: 19165808, PMCID: PMC2668727, DOI: 10.1002/cncr.24171.Peer-Reviewed Original ResearchConceptsPhase 2 trialEarly phase clinical trialsPhase 1 studyPhase 1 trialClinical trialsVital sign determinationsCancer clinical trialsPhysical examinationEarly phase cancer clinical trialsWeeks of protocolPhase 2 studyPhase 1 cancer clinical trialsNew drug studyStudy requirementsPhase 1Pharmacokinetic samplingMore patientsMedical oncologyOncology communityLaboratory testsSuch trialsDrug studiesTrialsPhase 1 programElectrocardiogram
2006
Safety and antitumor activity of AMG 706 in patients (pts) with thyroid cancer (TC): A subset analysis from a phase 1 dose-finding study
Boughton D, Rosen L, Van Vugt A, Kurzrock R, Eschenberg M, Wiezorek J, Ingram M, Wang D, Stepan D, Herbst R. Safety and antitumor activity of AMG 706 in patients (pts) with thyroid cancer (TC): A subset analysis from a phase 1 dose-finding study. Journal Of Clinical Oncology 2006, 24: 3030-3030. DOI: 10.1200/jco.2006.24.18_suppl.3030.Peer-Reviewed Original ResearchAMG 706Partial responseThyroid cancerStable diseaseAntitumor activityPhase 1 dose-finding studyTreatment-related adverse eventsPhase 2 studyRefractory solid tumorsStage IV diseasePhase 1 studySmall-molecule multi-kinase inhibitorAdvanced thyroid cancerMedullary thyroid cancerDose-finding studyDirect antitumor activityMulti-kinase inhibitorECOG 1Baseline demographicsObjective responseProgressive diseaseAdverse eventsMedian ageMedian timeConfirmation of response