2024
Phase II study of MEK inhibitor trametinib alone and in combination with AKT inhibitor GSK2141795/uprosertib in patients with metastatic triple negative breast cancer
Prasath V, Boutrid H, Wesolowski R, Abdel-Rasoul M, Timmers C, Lustberg M, Layman R, Macrae E, Mrozek E, Shapiro C, Glover K, Vater M, Budd G, Harris L, Isaacs C, Dees C, Perou C, Johnson G, Poklepovic A, Chen H, Villalona-Calero M, Carson W, Stover D, Ramaswamy B. Phase II study of MEK inhibitor trametinib alone and in combination with AKT inhibitor GSK2141795/uprosertib in patients with metastatic triple negative breast cancer. Breast Cancer Research And Treatment 2024, 1-11. PMID: 39644403, DOI: 10.1007/s10549-024-07551-z.Peer-Reviewed Original ResearchMetastatic triple negative breast cancerProgression-free survivalCirculating tumor DNATriple negative breast cancerTrametinib monotherapyNegative breast cancerStable diseasePartial responseBreast cancerCirculating tumor DNA clearanceMedian progression-free survivalClinical benefit rateMEK inhibitor trametinibPhase II studyBiomarkers of responseTreated with chemotherapyPotential early biomarkersInhibitor trametinibOpen-labelOverall survivalConclusionIn patientsDevelopment of resistanceObjective responseTumor DNABenefit ratePhase 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
2015
Biomodulation of capecitabine by paclitaxel and carboplatin in advanced solid tumors and adenocarcinoma of unknown primary
Mikhail S, Lustberg M, Ruppert A, Mortazavi A, Monk P, Kleiber B, Villalona-Calero M, Bekaii-Saab T. Biomodulation of capecitabine by paclitaxel and carboplatin in advanced solid tumors and adenocarcinoma of unknown primary. Cancer Chemotherapy And Pharmacology 2015, 76: 1005-1012. PMID: 26416564, DOI: 10.1007/s00280-015-2877-6.Peer-Reviewed Original ResearchMeSH KeywordsActivation, MetabolicAdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCapecitabineCarboplatinDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleEnzyme InductionEsophageal NeoplasmsFatigueFemaleGene Expression Regulation, NeoplasticHematologic DiseasesHumansKaplan-Meier EstimateMaleMaximum Tolerated DoseMiddle AgedNeoplasmsNeoplasms, Unknown PrimaryPaclitaxelPancreatic NeoplasmsProdrugsThymidine PhosphorylaseTreatment OutcomeUp-RegulationYoung AdultConceptsAdvanced solid tumorsII studyUnknown primaryDay 1Phase I/II studySolid tumorsPhase IPhase II patientsAntitumor activityObjective response ratePhase II dosePhase II studyMaximal tolerable doseSynergistic antitumor activityCessation of fundingCapecitabine 750Paclitaxel 60Disease stabilizationAcceptable tolerabilityAdvanced adenocarcinomaPartial responseCarboplatin AUCII patientsTolerable dosePatients