2024
Phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with gastrointestinal (GI) cancers receiving FOLFOX chemotherapy with or without bevacizumab.
Noonan A, Schnell P, Trunzo D, Thornton W, Malalur P, Manne A, Abushahin L, Rahman S, Jin N, Hays J, Elkhatib R, Mittra A, Roychowdhury S, Lustberg M, Sparreboom A, Hu S. Phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with gastrointestinal (GI) cancers receiving FOLFOX chemotherapy with or without bevacizumab. Journal Of Clinical Oncology 2024, 42: 745-745. DOI: 10.1200/jco.2024.42.3_suppl.745.Peer-Reviewed Original ResearchOrganic cation transporter 2Serum biomarkersEfficacy biomarkersRecommended phase 2 doseRandomized phase II studySide effect of oxaliplatinRat dorsal root gangliaEarly study discontinuationMFOLFOX6 + bevacizumabPhase 2 doseStudy of dasatinibGastrointestinal (GI) cancersOxaliplatin-induced neuropathyPhase II studyEffect of oxaliplatinPhase I trialDose-finding studyLow intermittent dosesDorsal root gangliaDisabling side effectsDose of DAddition of DFOLFOX chemotherapyFOLFOX regimenStudy discontinuation
2023
A phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with gastrointestinal (GI) cancers receiving FOLFOX chemotherapy with or without bevacizumab.
Noonan A, Farid S, Schnell P, Trunzo D, Malalur P, Jin N, Manne A, Abushahin L, Rahman S, Hays J, Elkhatib R, Mittra A, Roychowdhury S, Lustberg M, Sparreboom A, Hu S. A phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with gastrointestinal (GI) cancers receiving FOLFOX chemotherapy with or without bevacizumab. Journal Of Clinical Oncology 2023, 41: e15613-e15613. DOI: 10.1200/jco.2023.41.16_suppl.e15613.Peer-Reviewed Original ResearchOrganic cation transporter 2Efficacy biomarkersRandomized phase II studyRat dorsal root gangliaAmount of oxaliplatinPhase 2 doseOxaliplatin-induced neuropathyPhase II studyPhase I trialDose-finding studyDorsal root gangliaLevels of biomarkersMajority of ptsFOLFOX chemotherapyFOLFOX regimenOX administrationII studyI trialPeripheral neuropathyGastrointestinal cancerGI cancersPreclinical dataRoot gangliaSerum biomarkersCohort 2
2014
Phase I trial of the PARP inhibitor veliparib (V) in combination with carboplatin (C) in metastatic breast cancer (MBC).
Wesolowski R, Zhao M, Geyer S, Lustberg M, Mrozek E, Layman R, Macrae E, Zhang J, Hall N, Schregel K, Ottman S, Camp A, Chalmers J, Andreopoulou E, Villalona-Calero M, Shapiro C, Knopp M, Grever M, Ramaswamy B. Phase I trial of the PARP inhibitor veliparib (V) in combination with carboplatin (C) in metastatic breast cancer (MBC). Journal Of Clinical Oncology 2014, 32: 1074-1074. DOI: 10.1200/jco.2014.32.15_suppl.1074.Peer-Reviewed Original Research
2013
NCI 8609: Interim fluoro-3’-deoxythymidine (FLT) PET imaging findings from the phase I trial of PARP inhibitor veliparib (V) and carboplatin (C) in advanced breast cancer.
Ramaswamy B, Zhang J, Hall N, Schregel K, Lustberg M, Wesolowski R, Mrozek E, Layman R, Olson E, Ottman S, Camp A, Chalmers J, Geyer S, Villalona-Calero M, Shapiro C, Grever M, Knopp M. NCI 8609: Interim fluoro-3’-deoxythymidine (FLT) PET imaging findings from the phase I trial of PARP inhibitor veliparib (V) and carboplatin (C) in advanced breast cancer. Journal Of Clinical Oncology 2013, 31: 1023-1023. DOI: 10.1200/jco.2013.31.15_suppl.1023.Peer-Reviewed Original ResearchPET/CTFLT PET/CTAdvanced breast cancerPhase I trialFLT uptakeDay 7I trialBreast cancerPARP inhibitorsFDG PET/CTFLT PET uptakeFLT-PET imagingPARP inhibitor veliparibUptake of FLTCycle 3Dose-escalation designEligible ptsDose scheduleEscalation designFLT-PETFDG uptakeTrial protocolTherapy responseBlinded fashionImaging markerA first-in-human phase I trial of AR-12, a PDK-1 inhibitor, in patients with advanced solid tumors.
Mateo J, De Bono J, Ramanathan R, Lustberg M, Zivi A, Basset D, Ng M, Young A, Garrett M, Decordova S, Raynaud F, Yap T, Zukiwski A, Proniuk S, Shapiro C. A first-in-human phase I trial of AR-12, a PDK-1 inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2608-2608. DOI: 10.1200/jco.2013.31.15_suppl.2608.Peer-Reviewed Original ResearchPlatelet-rich plasmaAdvanced solid tumorsAR-12PK variabilitySafety dataFood effectSolid tumorsHuman phase I trialAdequate organ functionECOG PS 0Phase II doseDose-escalation studyPhase I trialDrug-related eventsHuman clinical trialsHigh PK variabilityCOX-2 inhibitory activityMechanism of actionBID cohortQD cohortStable diseaseStudy drugPS 0I trialSingle dose20P NCI 8609: Multicenter Phase I Trial of PARP Inhibitor Veliparib with Carboplatin in Advanced Breast Cancer
Ramaswamy B, Geyer S, Lustberg M, Wesolowski R, Andreopoulou E, Knopp M, Villalona M, Chen A, Grever M, Shapiro C. 20P NCI 8609: Multicenter Phase I Trial of PARP Inhibitor Veliparib with Carboplatin in Advanced Breast Cancer. Annals Of Oncology 2013, 24: iii19. DOI: 10.1093/annonc/mdt081.1.Peer-Reviewed Original ResearchSevere and prolonged lymphopenia observed in patients treated with bendamustine and erlotinib for metastatic triple negative breast cancer
Layman R, Ruppert A, Lynn M, Mrozek E, Ramaswamy B, Lustberg M, Wesolowski R, Ottman S, Carothers S, Bingman A, Reinbolt R, Kraut E, Shapiro C. Severe and prolonged lymphopenia observed in patients treated with bendamustine and erlotinib for metastatic triple negative breast cancer. Cancer Chemotherapy And Pharmacology 2013, 71: 1183-1190. PMID: 23430121, PMCID: PMC3710373, DOI: 10.1007/s00280-013-2112-2.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideBreast NeoplasmsCD4 Lymphocyte CountDose-Response Relationship, DrugErbB ReceptorsErlotinib HydrochlorideFemaleHumansLymphopeniaMiddle AgedNeoplasm MetastasisNitrogen Mustard CompoundsQuinazolinesSeverity of Illness IndexConceptsDose level 2Negative breast cancerCD4 countProlonged lymphopeniaBreast cancerMetastatic triple-negative breast cancerPurposeTriple-negative breast cancerEpidermal growth factor receptor expressionTriple-negative breast cancerEGFR tyrosine kinase inhibitorsDepressed CD4 countGrade 3/4 lymphopeniaDose level 1ECOG performance statusGrowth factor receptor expressionPhase I trialTyrosine kinase inhibitorsFactor receptor expressionHigh epidermal growth factor receptor (EGFR) expressionBendamustine combinationsConclusionsCombination therapyIntravenous bendamustineOral erlotinibPrior chemotherapyMetastatic disease