2024
Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103)
Garralda E, Oh Y, Italiano A, Bedard P, Delord J, Calvo E, LoRusso P, Wainberg Z, Cervantes A, Rodriguez‐Vida A, Shemesh C, Sane R, Mendus D, Ding H, Hendricks R, Meng R, Cho B, Kim T, Wu B. Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103). The Journal Of Clinical Pharmacology 2024, 64: 544-554. PMID: 38105505, DOI: 10.1002/jcph.2397.Peer-Reviewed Original ResearchSolid tumorsMixed solid tumorsDose-proportional mannerDrug-drug interactionsSlower elimination phaseSequential dosingInter-individual variabilityIntravenous infusionSystemic exposureImmunogenicity assessmentAtezolizumabHuman studiesElimination phasePK dataPK profilesPK propertiesPatientsMonoclonal antibodiesSerum samplesPharmacokineticsDays/Multiple timepointsSingle timepointGeometric meanQ4W
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
497P Dose-Escalation Phase I Study of Cabazitaxel (CBZ) + Gemcitabine (GEM) in Patients (PTS) with Metastatic or Unresectable Advanced Solid Malignancy
Rixe O, Puzanov I, LoRusso P, Yin J, Doroumian S, Zhi X, Olszanski A. 497P Dose-Escalation Phase I Study of Cabazitaxel (CBZ) + Gemcitabine (GEM) in Patients (PTS) with Metastatic or Unresectable Advanced Solid Malignancy. Annals Of Oncology 2012, 23: ix170. DOI: 10.1016/s0923-7534(20)33059-3.Peer-Reviewed Original ResearchTreatment-emergent AEsAdministration sequenceFebrile neutropeniaMetastatic castration-resistant prostate cancerDose-escalation phase IAntitumour activityCastration-resistant prostate cancerPhase IPreliminary PK dataAdvanced solid malignanciesGrade 4 neutropeniaAlternative dosing regimensDrug-drug interactionsUnresectable solid tumorsDrug administration sequenceStable diseaseHaematological toxicityTaxane combinationsOverall survivalPartial responseAdvanced cancerDosing regimensGEM 1000Study treatmentTolerable combination