2019
A phase 1 trial of the oral DNA methyltransferase inhibitor CC‐486 and the histone deacetylase inhibitor romidepsin in advanced solid tumors
Gaillard SL, Zahurak M, Sharma A, Durham J, Reiss K, Sartorius‐Mergenthaler S, Downs M, Anders N, Ahuja N, Rudek M, Azad N. A phase 1 trial of the oral DNA methyltransferase inhibitor CC‐486 and the histone deacetylase inhibitor romidepsin in advanced solid tumors. Cancer 2019, 125: 2837-2845. PMID: 31012962, PMCID: PMC6663621, DOI: 10.1002/cncr.32138.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overAnorexiaAntineoplastic Combined Chemotherapy ProtocolsAzacitidineDepsipeptidesDNA Modification MethylasesDrug Administration ScheduleFemaleHistone Deacetylase InhibitorsHumansLong Interspersed Nucleotide ElementsMaleMaximum Tolerated DoseMethyltransferasesMiddle AgedNauseaNeoplasmsConceptsHistone deacetylase inhibitor romidepsinDisease control rateAdvanced solid tumorsPhase 1 studyCC-486Solid tumorsDose-escalation portionPhase 2 doseDose-limiting toxicityPossible clinical benefitPhase 1 trialDose-escalation designElement-1 methylationLINE-1 methylationStable diseaseCommon toxicitiesDose expansionExpansion cohortPrimary outcomeClinical benefitControl rateDrug exposureBlood samplesDay 1Dose levels
2018
A Phase I Trial of a Guadecitabine (SGI-110) and Irinotecan in Metastatic Colorectal Cancer Patients Previously Exposed to Irinotecan
Lee V, Wang J, Zahurak M, Gootjes E, Verheul H, Parkinson R, Kerner Z, Sharma A, Rosner G, De Jesus-Acosta A, Laheru D, Le DT, Oganesian A, Lilly E, Brown T, Jones P, Baylin S, Ahuja N, Azad N. A Phase I Trial of a Guadecitabine (SGI-110) and Irinotecan in Metastatic Colorectal Cancer Patients Previously Exposed to Irinotecan. Clinical Cancer Research 2018, 24: 6160-6167. PMID: 30097434, DOI: 10.1158/1078-0432.ccr-18-0421.Peer-Reviewed Original ResearchConceptsMetastatic colorectal cancerNeutropenic feverMetastatic colorectal cancer patientsDurable partial responseMost common toxicitiesDose-escalation studyColorectal cancer patientsInjection site reactionsOngoing phase IIPhase I trialInitial disease progressionCycles of treatmentCommon toxicitiesDrain infectionEvaluable patientsStable diseaseColonic obstructionPartial responseI trialMulticenter trialColorectal cancerGastrointestinal cancerSite reactionsCancer patientsDisease progression