2024
A phase I study of irinotecan combined with BAY1895344 (ATR inhibitor) in advanced solid tumors: Results of ETCTN 10402 dose escalation.
Heumann T, Stockton S, Cecchini M, Aljumaily R, Shyr C, Whisenant J, Starr J, Dayyani F, Baranda J, Trikalinos N, Ivy S, LoRusso P, Das S, Gore S, Beumer J, Berlin J. A phase I study of irinotecan combined with BAY1895344 (ATR inhibitor) in advanced solid tumors: Results of ETCTN 10402 dose escalation. Journal Of Clinical Oncology 2024, 42: 3077-3077. DOI: 10.1200/jco.2024.42.16_suppl.3077.Peer-Reviewed Original ResearchAdvanced solid tumorsMaximum tolerated doseDose escalationSolid tumorsPhase I study of irinotecanRecommended phase 2 doseRefractory advanced solid tumorsPhase 2 dosePhase I studyAnti-tumor activityBiweekly irinotecanInhibitor irinotecanIrinotecan exposureWeekly irinotecanTolerated doseDosing scheduleCancer xenograftsAdult patientsIrinotecanAssess safetyATR inhibitorsElimusertibSecondary objectivesDoseStandard careEfficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series
Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Macarulla T, Geng J, Li J, Teufel M, Märten A, LoRusso P. Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series. OncoTargets And Therapy 2024, 17: 267-280. PMID: 38567193, PMCID: PMC10986405, DOI: 10.2147/ott.s440979.Peer-Reviewed Original ResearchBiliary tract cancerAdvanced biliary tract cancerAdverse eventsDose reduction due to adverse eventsBiliary tract cancer casesChemotherapy plus immunotherapyPhase Ia/Ib trialPD-1 inhibitorsSecond-line optionAnti-tumor activityStable diseasePartial responsePD-1Treatment discontinuationCase seriesSafety profilePatientsImprove outcomesMolecular heterogeneityCancerMDM2-p53DiseaseImmunotherapyDoseEfficacy
2023
1029P Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced or metastatic solid tumors: Preliminary safety, PK/PD, and anti-tumor activity in a phase I dose escalation study supporting a recommended dose for expansion (RDE)
Olszanski A, Luke J, LoRusso P, Falchook G, Bedard P, Sanborn R, Patel S, Orr D, Gibbs J, Li C, Huang Y, Gregory R, Perera S, Xu R, Joshi A, Lee M, Raizer J, Gao X. 1029P Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced or metastatic solid tumors: Preliminary safety, PK/PD, and anti-tumor activity in a phase I dose escalation study supporting a recommended dose for expansion (RDE). Annals Of Oncology 2023, 34: s625-s626. DOI: 10.1016/j.annonc.2023.09.2168.Peer-Reviewed Original Research
2019
466P Interim results from trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumours
Wang J, Barve M, Chiorean E, LoRusso P, Courtney K, Qi D, Bullington J, Sardone M, Chen J, Brooks C, Shemesh S, Bauer T. 466P Interim results from trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumours. Annals Of Oncology 2019, 30: v175. DOI: 10.1093/annonc/mdz244.028.Peer-Reviewed Original ResearchSchedule ADay 1Optimal dose/schedulePreliminary anti-tumor activityDose-escalation stageStudy dose levelsMetastatic solid tumorsDose/scheduleAggressive tumor behaviorAnti-tumor activityAssess pharmacokineticsStarting doseDose intensityStandard therapyPoor prognosisHematologic malignanciesTumor behaviorDose levelsSolid tumorsPatientsNuclear export proteinVivo activityDoseLonger recovery timeDays
2003
546 A phase I dose-escalation trial of ZD6126 administered as 5 daily dose every 3 weeks to patients with cancer refractory to other treatments
Budd G, Evelhoch J, Langmuir P, Veiero J, Shepherdson K, LoRusso P. 546 A phase I dose-escalation trial of ZD6126 administered as 5 daily dose every 3 weeks to patients with cancer refractory to other treatments. European Journal Of Cancer Supplements 2003, 1: s165. DOI: 10.1016/s1359-6349(03)90578-7.Peer-Reviewed Original Research
1999
Phase II study of CI-958 in colorectal cancer
Shields A, Philip P, LoRusso P, Ferris A, Zalupski M. Phase II study of CI-958 in colorectal cancer. Cancer Chemotherapy And Pharmacology 1999, 43: 162-164. PMID: 9923823, DOI: 10.1007/s002800050878.Peer-Reviewed Original ResearchConceptsAdvanced colorectal cancerColorectal cancerCI-958Patient experienced febrile neutropeniaAcute febrile reactionExperienced febrile neutropeniaPhase II studyPhase II trialStart of treatmentFebrile neutropeniaII trialMetastatic settingII studyMajor toxicityMedian survivalMetastatic diseaseObjective responseFebrile reactionsPatientsCancerDoseTreatmentLeukopeniaNeutropeniaRegimen
1998
Evaluation of pyrazoloacridine in patients with advanced pancreatic carcinoma
Zalupski M, Shields A, Philip P, Kraut M, LoRusso P, Heilbrun L, Vaitkevicius V. Evaluation of pyrazoloacridine in patients with advanced pancreatic carcinoma. Investigational New Drugs 1998, 16: 93-96. PMID: 9740550, DOI: 10.1023/a:1006087114621.Peer-Reviewed Original ResearchConceptsPancreatic carcinomaBroad preclinical antitumor activityUntreated advanced pancreatic cancerAdvanced pancreatic cancerAdvanced pancreatic carcinomaPhase II trialSchedule of administrationPreclinical antitumor activityModerate neutropeniaPredictable toxicityII trialMajor toxicityClinical efficacyMild neurotoxicityPancreatic cancerClinical developmentPatientsPyrazoloacridinePhase IAntitumor activitySolid tumor selectivityTumor selectivityCarcinomaDoseToxicity
1997
Phase II study of pyrazoloacridine in patients with advanced colorectal carcinoma
Zalupski M, Philip P, LoRusso P, Shields A. Phase II study of pyrazoloacridine in patients with advanced colorectal carcinoma. Cancer Chemotherapy And Pharmacology 1997, 40: 225-227. PMID: 9219505, DOI: 10.1007/s002800050650.Peer-Reviewed Original ResearchConceptsColorectal cancerBroad preclinical antitumor activityUntreated advanced colorectal cancerPhase II studyAdvanced colorectal cancerPhase II trialSchedule of administrationAdvanced colorectal carcinomaPreclinical antitumor activityPredictable toxicityII trialII studyClinical efficacyColorectal carcinomaClinical developmentPatientsPyrazoloacridinePhase IAntitumor activitySolid tumor selectivityTumor selectivityCancerDoseToxicityMyelosuppression
1994
Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analogues
Corbett T, Lowichik N, Pugh S, Polin L, Panchapor C, White K, Knight J, Demchik L, Jones J, Jones L, Biernat L, Lorusso P, Foster B, Heilbrun L, Rake J, Mattes K, Perni R, Powles R, Hlavac A, Wentland M, Coughlin S, Baker L, Valeriote F. Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analogues. Expert Opinion On Investigational Drugs 1994, 3: 1281-1292. DOI: 10.1517/13543784.3.12.1281.Peer-Reviewed Original ResearchLiver toxicityAntitumour activityClinical trialsPhase I clinical trialSevere liver toxicityEfficacious dose levelsPreclinical modelsDose levelsBetter efficacyWeekly scheduleAntischistosomal agentsDay scheduleHycanthoneM2 levelToxicityTrialsMost analoguesAgentsRecovery timeVariety of analoguesGroupActivityMiceDose