2023
Phase Ib study of HSP90 inhibitor, onalespib (AT13387), in combination with paclitaxel in patients with advanced triple-negative breast cancer
Williams N, Quiroga D, Johnson C, Brufsky A, Chambers M, Bhattacharya S, Patterson M, Sardesai S, Stover D, Lustberg M, Noonan A, Cherian M, Bystry D, Hill K, Chen M, Phelps M, Grever M, Stephens J, Ramaswamy B, Carson W, Wesolowski R. Phase Ib study of HSP90 inhibitor, onalespib (AT13387), in combination with paclitaxel in patients with advanced triple-negative breast cancer. Therapeutic Advances In Medical Oncology 2023, 15: 17588359231217976. PMID: 38152697, PMCID: PMC10752118, DOI: 10.1177/17588359231217976.Peer-Reviewed Original ResearchAdvanced triple-negative breast cancerTriple-negative breast cancerProgression-free survivalDuration of responseOverall response ratePrior taxane therapyAdverse eventsTaxane therapyCombination therapyBreast cancerMedian DORMedian progression-free survivalNon-hematologic adverse eventsPhase Ib studyPhase Ib trialPhase II doseAcceptable toxicity profileDose-limiting toxicityDrug interaction profileIb trialIntravenous paclitaxelPaclitaxel efficacyExpansion cohortCombination regimenMetastatic disease
2020
A phase Ib study of the safety and pharmacology of nilotinib to prevent paclitaxel-induced peripheral neuropathy in patients with breast cancer.
Adams E, Lustberg M, Jin Y, Li Y, Sparreboom A, Hu S. A phase Ib study of the safety and pharmacology of nilotinib to prevent paclitaxel-induced peripheral neuropathy in patients with breast cancer. Journal Of Clinical Oncology 2020, 38: tps12128-tps12128. DOI: 10.1200/jco.2020.38.15_suppl.tps12128.Peer-Reviewed Original ResearchChemotherapy-induced peripheral neuropathyPaclitaxel infusionFree survivalPeripheral neuropathyBreast cancerPaclitaxel-induced peripheral neuropathyBreast cancer stage IEarly-stage breast cancerGrade 2 neuropathyPhase Ib studyPhase II doseDisease-free survivalCancer stage IStage breast cancerBreast cancer therapyTyrosine kinase inhibitorsQuality of lifeOrganic anion transportingOATP1B1 inhibitionOral nilotinibWeekly paclitaxelPaclitaxel dosePaclitaxel therapyOverall survivalWeekly doses
2017
Phase Ib study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple-negative breast cancer (NCT02474173).
Wesolowski R, Lustberg M, Reinbolt R, VanDeusen J, Sardesai S, Williams N, Noonan A, Dewani S, Poi M, Wilson D, Grever M, Stephens J, Puhalla S, Mathew A, Carson W, Ramaswamy B. Phase Ib study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple-negative breast cancer (NCT02474173). Journal Of Clinical Oncology 2017, 35: tps1127-tps1127. DOI: 10.1200/jco.2017.35.15_suppl.tps1127.Peer-Reviewed Original ResearchTriple-negative breast cancerBreast cancerDay 1Hormone receptor-positive breast cancerReceptor-positive breast cancerPhase Ib studyPhase II doseProgression-free survivalPositive breast cancerOverall response rateHeat shock protein 90 inhibitorNegative breast cancerCycle 1Shock protein 90 inhibitorsPoor outcomeStandard doseAndrogen receptorHsp90 client proteinsHeat shock protein 90Ib studyResponse durationToxicity profilePaclitaxel resistanceClient proteinsDay 7
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
2013
A 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 dose