2019
Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine
Garcia-Manero G, McCloskey J, Griffiths E, Yee K, Zeidan A, Al-Kali A, Dao K, Deeg H, Patel P, Sabloff M, Keating M, Zhu N, Gabrail N, Fazal S, Maly J, Odenike O, Shastri A, DeZern A, O'Connell C, Roboz G, Oganesian A, Hao Y, Keer H, Azab M, Savona M. Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine. Blood 2019, 134: 846. DOI: 10.1182/blood-2019-122980.Peer-Reviewed Original ResearchPhase 3 studyFixed-dose combinationClinical trialsHematologic improvementAdverse eventsAstex PharmaceuticalsSpeakers bureauIncyte CorporationSafety findingsComplete responseRandomized crossOtsuka PharmaceuticalClinical activityHypomethylating agentOral fixed-dose combinationCelgene CorporationRandomized phase 3 studyBoehringer IngelheimAdvisory CommitteeSeattle GeneticsDaiichi SankyoClinic visit frequencyComparable clinical activityDifferent myeloid malignanciesPlatelet transfusion dependence
2017
A Phase 1/2 Study of the Oral Novel JAK1 Inhibitor INCB052793 As Monotherapy and in Combination with Standard Therapies in Patients with Advanced Hematologic Malignancies
Zeidan A, Cook R, Bordoni R, Asatiani E, Zhou G, Faivre T, Byrne M, Savona M. A Phase 1/2 Study of the Oral Novel JAK1 Inhibitor INCB052793 As Monotherapy and in Combination with Standard Therapies in Patients with Advanced Hematologic Malignancies. Blood 2017, 130: 640. DOI: 10.1182/blood.v130.suppl_1.640.640.Peer-Reviewed Original ResearchAdvanced acute myeloid leukemiaMDS/MPNAdvanced hematologic malignanciesOverall response rateHigh-risk myelodysplastic syndromePhase 1/2 studyComplete responseIncyte CorporationMyelodysplastic syndromeCombination therapyMultiple myelomaHematologic malignanciesData cutoffAdverse eventsStandard therapySpeakers bureauJAK/STAT pathwayPreliminary safetyDisease progressionEfficacy dataMorphologic leukemia-free stateOngoing phase 1/2 studyJAK1 inhibitorAdvisory CommitteeAdvanced myeloid malignancies