2014
First Clinical Results of a Randomized Phase 2 Dose-Response Study of SGI-110, a Novel Subcutaneous (SC) Hypomethylating Agent (HMA), in 102 Patients with Intermediate (Int) or High Risk (HR) Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
Garcia-Manero G, Ritchie E, Walsh K, Savona M, Kropf P, O’Connell C, Tibes R, Daver N, Jabbour E, Lunin S, Rosenblat T, Yee K, Stock W, Griffiths E, Mace J, Podoltsev N, Berdeja J, Issa J, Chung W, Naim S, Taverna P, Hao Y, Azab M, Kantarjian H, Roboz G. First Clinical Results of a Randomized Phase 2 Dose-Response Study of SGI-110, a Novel Subcutaneous (SC) Hypomethylating Agent (HMA), in 102 Patients with Intermediate (Int) or High Risk (HR) Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML). Blood 2014, 124: 529. DOI: 10.1182/blood.v124.21.529.529.Peer-Reviewed Original ResearchTreatment-naïve patientsMyelodysplastic syndromeChronic myelomonocytic leukemiaTreatment armsCMML patientsHypomethylating agentClinical responseAdverse eventsAstex PharmaceuticalsSGI-110Marrow CRNaïve patientsTransfusion independenceHematological improvementMDS patientsHigh-risk myelodysplastic syndromePhase 1 clinical trialECOG PS 2Treatment-naïve groupRisk myelodysplastic syndromesBaseline patient characteristicsFirst clinical resultsDose-response studySignificant differencesMedian follow
2013
First Clinical Results Of a Randomized Phase 2 Study Of SGI-110, a Novel Subcutaneous (SQ) Hypomethylating Agent (HMA), In Adult Patients With Acute Myeloid Leukemia (AML)
Kantarjian H, Jabbour E, Yee K, Kropf P, O'Connell C, Stock W, Tibes R, Rizzieri D, Walsh K, Griffiths E, Roboz G, Savona M, Ervin T, Podoltsev N, Pemmaraju N, Daver N, Garcia-Manero G, Borthakur G, Wierda W, Ravandi F, Cortes J, Brandwein J, Odenike O, Feldman E, Chung W, Naim S, Choy G, Taverna P, Hao Y, Dimitrov G, Azab M, Issa J. First Clinical Results Of a Randomized Phase 2 Study Of SGI-110, a Novel Subcutaneous (SQ) Hypomethylating Agent (HMA), In Adult Patients With Acute Myeloid Leukemia (AML). Blood 2013, 122: 497. DOI: 10.1182/blood.v122.21.497.497.Peer-Reviewed Original ResearchAcute myeloid leukemiaPhase 2 studyTreatment of AMLRandomized phase 2 studyRefractory acute myeloid leukemiaOverall remission rateAdverse eventsComplete remissionRemission rateAstex PharmaceuticalsHypomethylating agentAML patientsSGI-110Primary endpointDose groupElderly acute myeloid leukemiaLINE-1 demethylationElderly AML patientsCommon adverse eventsComplete remission ratePhase 1 trialStem cell transplantPhase 3 investigationFirst clinical resultsECOG PS