2025
Phase 1b portion of the ACTION-1 phase 1b/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings.
Strosberg J, Morris M, Ulaner G, Halperin D, Mehr S, Li D, Soares H, Anthony L, Kotiah S, Jacene H, Tesselaar M, Kunz P, Ferreira D, Li J, Ma K, Rearden J, Moran S, Hope T, Singh S. Phase 1b portion of the ACTION-1 phase 1b/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings. Journal Of Clinical Oncology 2025, 43: 661-661. DOI: 10.1200/jco.2025.43.4_suppl.661.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPhase 1b portionDose-limiting toxicitySerious adverse eventsGEP-NETsSomatostatin analoguesAdverse eventsFrequent treatment-emergent adverse eventsNo treatment emergent adverse eventsMedian duration of responseTime of data cutoffPlanned dose levelsProgression-free survivalGastroenteropancreatic neuroendocrine tumorsDuration of responseAlpha-emitting radiopharmaceuticalStandard of careDose holdRECIST v1.1Stable diseaseData cutoffDose delaysTumor responseDose modificationPartial response
2014
Phase Ib/II trial of gemcitabine, cisplatin, plus lenalidomide as first-line therapy for patients with metastatic urothelial carcinoma.
Tsao C, Agarwal N, Apolo A, Lee K, Godbold J, Oh W, Galsky M. Phase Ib/II trial of gemcitabine, cisplatin, plus lenalidomide as first-line therapy for patients with metastatic urothelial carcinoma. Journal Of Clinical Oncology 2014, 32: 321-321. DOI: 10.1200/jco.2014.32.4_suppl.321.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaDose-limiting toxicityPhase II portionDay 1Dose delaysDose reductionUrothelial carcinomaDose of lenalidomidePhase 1b portionPhase Ib portionPhase Ib/II trialGrade 4 neutropeniaProgression-free survivalEfficacy of gemcitabineCisplatin-based chemotherapyFirst-line therapyDose escalation rulesDose delays/reductionsStable diseasePartial responseStandard chemotherapyTumor responseCytotoxic chemotherapyLimiting toxicitiesSlow accrual
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