2020
Trial in progress: A phase I/II, open-label, dose-escalation, safety and tolerability study of NC318 in subjects with advanced or metastatic solid tumors.
Gutierrez M, Hamid O, Shum E, Wise D, Balar A, Weber J, LoRusso P, Shafi S, Rimm D, Tolcher A, Basudhar D, Dujka M, Heller K. Trial in progress: A phase I/II, open-label, dose-escalation, safety and tolerability study of NC318 in subjects with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2020, 38: tps3166-tps3166. DOI: 10.1200/jco.2020.38.15_suppl.tps3166.Peer-Reviewed Original ResearchMetastatic solid tumorsT cell functionSolid tumorsPD-L1 tumor proportion scoreAnti-tumor immune responseNon-small cell lungPhase I/IIPhase 2 doseTumor proportion scoreAnti-tumor immunityKey eligibility criteriaCell functionDose-escalation designBreast cancer subjectsNon-randomized studiesT cell proliferationPrevents tumor growthClass monoclonal antibodyCollection of biopsiesMeasurable diseaseRECIST v1.1Phase 1/2Escalation designTolerability studyImmune suppression
2019
343P Phase I dose escalation study of a selective androgen receptor modulator RAD140 in estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer (BC)
Hamilton E, Vidula N, Ma C, LoRusso P, Bagley R, Yu Z, Annett M, Weitzman A, Conlan M, Weise A. 343P Phase I dose escalation study of a selective androgen receptor modulator RAD140 in estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer (BC). Annals Of Oncology 2019, 30: v123. DOI: 10.1093/annonc/mdz242.038.Peer-Reviewed Original ResearchProstate-specific antigenSelective AR modulatorsALT/ASTBreast cancerMetastatic BCRadius HealthAndrogen receptorHER2-negative breast cancerSerum prostate-specific antigenAR agonist activityGenentech/RocheWeight/appetiteAntitumor activityFrequent adverse eventsAcceptable safety profileKey eligibility criteriaMetastatic breast cancerPhase 1 studyHormone-binding globulinAndrogen-responsive tissuesDrug-related deathsNegative breast cancerBristol-Myers SquibbFlatiron HealthStable disease
2015
Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors.
Wang D, Braiteh F, Lee J, Denlinger C, Shepard D, Chaudhary A, Lin Y, Gao L, Asakiewicz C, Nasroulah F, LoRusso P. Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors. Journal Of Clinical Oncology 2015, 33: 691-691. DOI: 10.1200/jco.2015.33.3_suppl.691.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAdvanced malignant solid tumorsPharmacokinetics of irinotecanMalignant solid tumorsMetabolite SN-38Folinic acidSN-38Safety populationStandard therapyEastern Cooperative Oncology Group performance statusSolid tumorsCycle 1Maximum observed drug concentrationFatigue/astheniaPhase II studyKey eligibility criteriaDose-normalized areaNew safety concernsC maxII studyPerformance statusAdverse eventsStudy treatmentIntravenous infusionPlasma concentrationsClinical activity of AMG 337, an oral MET kinase inhibitor, in adult patients (pts) with MET-amplified gastroesophageal junction (GEJ), gastric (G), or esophageal (E) cancer.
Kwak E, LoRusso P, Hamid O, Janku F, Kittaneh M, Catenacci D, Chan E, Bekaii-Saab T, Amore B, Hwang Y, Tang R, Ngarmchamnanrith G, Hong D. Clinical activity of AMG 337, an oral MET kinase inhibitor, in adult patients (pts) with MET-amplified gastroesophageal junction (GEJ), gastric (G), or esophageal (E) cancer. Journal Of Clinical Oncology 2015, 33: 1-1. DOI: 10.1200/jco.2015.33.3_suppl.1.Peer-Reviewed Original ResearchAMG 337MET kinase inhibitorGastroesophageal junctionGI cancersClinical activityCommon treatment-emergent AEsKinase inhibitorsAdequate organ functionDose-expansion phaseSubset of ptsTreatment-emergent AEsAdvanced solid tumorsDose-limiting toxicityKey eligibility criteriaAmplification/mutationMeasurable diseaseAdult patientsComplete responsePartial responseDose escalationMedian ageGI tumorsAE profileEsophageal cancerMET pathway