2014
Phase I and IIa studies of simtuzumab alone and in combination with FOLFIRI in patients with advanced solid tumors.
LoRusso P, Hecht J, Thai D, Hawkins M, Dong H, Tolcher A. Phase I and IIa studies of simtuzumab alone and in combination with FOLFIRI in patients with advanced solid tumors. Journal Of Clinical Oncology 2014, 32: 554-554. DOI: 10.1200/jco.2014.32.3_suppl.554.Peer-Reviewed Original ResearchTreatment-emergent AEsAdvanced solid tumorsColorectal cancerDose expansionIIa studyPhase ISolid tumorsCommon treatment-emergent AEsKRAS-mutant colorectal cancerDrug-related SAEsPhase II studyPhase IIa trialPhase IIa studyMutant colorectal cancerExtracellular matrix enzymesMedian PFSIIa trialUnacceptable toxicityEscalation studyII studyDose escalationFourth dosesTumor sizePancreatic neuroendocrinePromising efficacy
2011
MEDI-573 as a novel approach to IGF-1R and IR-A signaling inhibition by blocking IGF ligands: Phase I PK/PD, safety data, and disease linkage studies in breast cancer.
Haluska P, Huang J, Lam B, Liang M, Huang W, LoRusso P, Menefee M, LaVallee T, Yao Y, Viner J. MEDI-573 as a novel approach to IGF-1R and IR-A signaling inhibition by blocking IGF ligands: Phase I PK/PD, safety data, and disease linkage studies in breast cancer. Journal Of Clinical Oncology 2011, 29: 271-271. DOI: 10.1200/jco.2011.29.27_suppl.271.Peer-Reviewed Original ResearchMEDI-573Breast cancerIR-B ratioIGF-1RGlucose levelsPhase Ib/II studyDrug-related SAEsAdvanced solid tumorsDose-escalation trialBreast cancer subsetsFree IGF-1Plasma glucose levelsFavorable PK profileDetermination of MTDPK/PDAdjacent normal tissuesStable diseaseII studyIV infusionAntidrug antibodiesSafety profileInsulin resistanceSignificant changesAcceptable safetyTumor response