2024
A phase II study of guadecitabine combined with irinotecan vs regorafenib or TAS‐102 in irinotecan‐refractory metastatic colorectal cancer patients
Lee V, Parkinson R, Zahurak M, Cope L, Cercek A, Verheul H, Gootjes E, Lenz H, Iqbal S, Jones P, Baylin S, Rami V, Ahuja N, Khoueiry A, Azad N. A phase II study of guadecitabine combined with irinotecan vs regorafenib or TAS‐102 in irinotecan‐refractory metastatic colorectal cancer patients. International Journal Of Cancer 2024, 154: 1794-1801. PMID: 38312102, DOI: 10.1002/ijc.34845.Peer-Reviewed Original ResearchRefractory to irinotecanArm ATAS-102DNA methyltransferase inhibitorArm BRates of progression free survivalB. Median overall survivalEvidence of target modulationMetastatic colorectal cancer patientsResistant to systemic therapyTreatment related adverse eventsProgression free survivalPhase II studyPhase II trialKaplan-Meier ratesRelated adverse eventsColorectal cancer patientsFree survivalOverall survivalSystemic therapyAdverse eventsIrinotecanRegorafenibCancer patientsGuadecitabine
2022
A randomized, phase II trial of oral azacitidine (CC-486) in patients with resected pancreatic adenocarcinoma at high risk for recurrence
Heumann T, Baretti M, Sugar E, Durham J, Linden S, Lopez-Vidal T, Leatherman J, Cope L, Sharma A, Weekes C, O’Dwyer P, Reiss K, Monga D, Ahuja N, Azad N. A randomized, phase II trial of oral azacitidine (CC-486) in patients with resected pancreatic adenocarcinoma at high risk for recurrence. Clinical Epigenetics 2022, 14: 166. PMID: 36463226, PMCID: PMC9719150, DOI: 10.1186/s13148-022-01367-8.Peer-Reviewed Original ResearchConceptsResectable pancreatic ductal adenocarcinomaCC-486OBS patientsMetastatic settingAdjuvant therapyTreatment-related grade 3Randomized phase II studyMedian age 66Next-line therapyResultsForty-nine patientsMedian treatment durationPhase II studyEvidence of diseaseHigh-risk featuresPhase II trialProgression-free survivalStandard adjuvant therapyPancreatic ductal adenocarcinomaCancer recursEvaluable patientsMedian OSMedian PFSOral azacitidineR1 resectionSubsequent chemotherapy
2020
22 Poster Discussion A phase II study of Guadecitabine (G) with Irinotecan (IRI) vs regorafenib or TAS-102 in metastatic colorectal cancer (mCRC) patients (pts)
Lee V, Zahurak M, Cercek A, Verheul H, Lenz H, Jones P, Baylin S, Parkinson R, Rami V, Lilly E, Miles T, Brown T, Ahuja N, Khoueiry A, Azad N. 22 Poster Discussion A phase II study of Guadecitabine (G) with Irinotecan (IRI) vs regorafenib or TAS-102 in metastatic colorectal cancer (mCRC) patients (pts). European Journal Of Cancer 2020, 138: s12. DOI: 10.1016/s0959-8049(20)31096-0.Peer-Reviewed Original Research
2017
Combination Epigenetic Therapy in Advanced Breast Cancer with 5-Azacitidine and Entinostat: A Phase II National Cancer Institute/Stand Up to Cancer Study
Connolly RM, Li H, Jankowitz RC, Zhang Z, Rudek MA, Jeter SC, Slater SA, Powers P, Wolff AC, Fetting JH, Brufsky A, Piekarz R, Ahuja N, Laird PW, Shen H, Weisenberger DJ, Cope L, Herman JG, Somlo G, Garcia AA, Jones PA, Baylin SB, Davidson NE, Zahnow CA, Stearns V. Combination Epigenetic Therapy in Advanced Breast Cancer with 5-Azacitidine and Entinostat: A Phase II National Cancer Institute/Stand Up to Cancer Study. Clinical Cancer Research 2017, 23: 2691-2701. PMID: 27979916, PMCID: PMC5457329, DOI: 10.1158/1078-0432.ccr-16-1729.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerObjective response rateCombination epigenetic therapyEstrogen receptorEndocrine therapyPrimary endpointPartial responseMulticenter phase II studyEpigenetic therapyAdditional partial responsesHormone-resistant diseasePhase II studyTime of progressionBreast cancer modelClin Cancer ResHistone deacetylase inhibitorsImportant therapeutic targetPosttreatment biopsiesTNBC cohortII studyBreast cancerDNA methyltransferase inhibitorTherapeutic targetResponse rateCancer model
2015
A phase I study of investigational agent SGI-110 combined with irinotecan in previously treated metastatic colorectal cancer patients.
Wang J, Gootjes E, Uram J, Zahurak M, El-Khoueiry A, Verheul H, Ahuja N, Azad N. A phase I study of investigational agent SGI-110 combined with irinotecan in previously treated metastatic colorectal cancer patients. Journal Of Clinical Oncology 2015, 33: tps797-tps797. DOI: 10.1200/jco.2015.33.3_suppl.tps797.Peer-Reviewed Original ResearchDose level 1SGI-110Colorectal cancerPhase ITumor biopsiesDay 1Metastatic colorectal cancer patientsRandomized phase II studyMajor eligibility criteriaPeriodic CT scansPhase II studyGrowth factor supportColorectal cancer patientsM2 days 1Metastatic colon adenocarcinomaMetastatic colon cancerCRC cell linesAdditional dose levelsEvaluation of biomarkersMeasureable diseaseTotal therapyII studyIrinotecan therapyDose escalationFactor support
2013
A phase II study of combination epigenetic therapy in metastatic colorectal cancer (mCRC): A phase II consortium (P2C)/Stand Up 2 Cancer (SU2C) study.
Azad N, El-Khoueiry A, Mahoney M, Adkins D, Flynn P, Bahary N, Kim G, Pitot H, Erlichman C, Donehower R, Herman J, Baylin S, Ahuja N. A phase II study of combination epigenetic therapy in metastatic colorectal cancer (mCRC): A phase II consortium (P2C)/Stand Up 2 Cancer (SU2C) study. Journal Of Clinical Oncology 2013, 31: 3539-3539. DOI: 10.1200/jco.2013.31.15_suppl.3539.Peer-Reviewed Original ResearchMetastatic colorectal cancerPrior regimensGood end-organ functionCombination epigenetic therapyECOG PS 0End-organ functionPhase II studyUrinary tract obstructionSerial tumor biopsiesInitial eligibility criteriaCRC cell linesMulti-institutional studyMCRC ptsChest painPrimary endpointPrior therapyRECIST criteriaTract obstructionII studyPS 0Cohort BCohort ALiver diseaseSubsequent therapyColorectal cancer
2011
OT3-01-06: A Phase 2 Study Investigating the Safety, Efficacy and Surrogate Biomarkers of Response of 5-Azacitidine (5-AZA) and Entinostat (MS-275) in Patients with Advanced Breast Cancer.
Connolly R, Jankowitz R, Andreopoulou E, Allred J, Jeter S, Zorzi J, Adam B, Espinoza-Delgado I, Baylin S, Zahnow C, Ahuja N, Davidson N, Stearns V. OT3-01-06: A Phase 2 Study Investigating the Safety, Efficacy and Surrogate Biomarkers of Response of 5-Azacitidine (5-AZA) and Entinostat (MS-275) in Patients with Advanced Breast Cancer. Cancer Research 2011, 71: ot3-01-06-ot3-01-06. DOI: 10.1158/0008-5472.sabcs11-ot3-01-06.Peer-Reviewed Original ResearchObjective response rateHistone deacetylase inhibitorsHormone-resistant diseaseAdvanced breast cancerBreast cancerDNA methyltransferase inhibitorHormonal therapyAdvanced human epidermal growth factor receptor 2Response rateMulticenter phase II studyHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Adequate organ functionClinical benefit rateRECIST 1.1 criteriaPhase II studyWeeks of therapyPhase 2 studyProgression-free survivalGrowth factor receptor 2Objective disease responseNegative breast cancerFactor receptor 2Important therapeutic targetCandidate gene methylation