2019
A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 (MDM2-p53 antagonist) in adult patients with advanced or metastatic solid tumors.
Chong C, Bauer T, Laurie S, Patel M, Yamamoto N, Davenport T, Geng J, Gibson N, Vallaster M, LoRusso P. A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 (MDM2-p53 antagonist) in adult patients with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2019, 37: tps3166-tps3166. DOI: 10.1200/jco.2019.37.15_suppl.tps3166.Peer-Reviewed Original ResearchDose-limiting toxicityMetastatic solid tumorsFirst treatment cycleSolid tumorsEvaluable patientsPrimary endpointTreatment cyclesPhase 1bPreliminary anti-tumor activityMDM2-p53 antagonistsNon-squamous NSCLCDose-escalation studyDose-escalation trialSoft tissue sarcomasNumber of patientsTP53 wild-type statusWild-type statusAnti-tumor activityMDM2 amplification statusTumor protein 53New anti-cancer drugsIA/IBOpen labelRECIST v1.1Brain metastases
2017
P2.03a-065 Lack of Drug-Drug Interaction (DDI) between Necitumumab and Gemcitabine or Cisplatin: A Phase 2, Open-Label, Nonrandomized Study Topic: Clinical Trials
Chaudhary A, Chao G, Braiteh F, Gordon M, Lee J, Lorusso P, Obasaju C, Wallin J. P2.03a-065 Lack of Drug-Drug Interaction (DDI) between Necitumumab and Gemcitabine or Cisplatin: A Phase 2, Open-Label, Nonrandomized Study Topic: Clinical Trials. Journal Of Thoracic Oncology 2017, 12: s928-s929. DOI: 10.1016/j.jtho.2016.11.1275.Peer-Reviewed Original Research
2012
507 Phase I, Open-Label, Randomized, Crossover Study Evaluating the Effects of Linifanib on Qtc Intervals in Patients with Solid Tumors
Chiu Y, LoRusso P, Ricker J, Li X, Pradhan R, Carlson D. 507 Phase I, Open-Label, Randomized, Crossover Study Evaluating the Effects of Linifanib on Qtc Intervals in Patients with Solid Tumors. Annals Of Oncology 2012, 23: ix173. DOI: 10.1016/s0923-7534(20)33069-6.Peer-Reviewed Original ResearchAdvanced solid tumorsDay 1Solid tumorsCardiac repolarizationAdequate organ functionECOG PS 0Primary end pointExposure-response analysisEffects modelMeasurable diseaseMorning doseOpen labelCrossover fashionPS 0QTc prolongationStandard therapyCrossover studyQTc intervalBaseline QTcFQTcF intervalStudy completion