2019
First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors
Piha-Paul SA, Sachdev JC, Barve M, LoRusso P, Szmulewitz R, Patel SP, Lara PN, Chen X, Hu B, Freise KJ, Modi D, Sood A, Hutti JE, Wolff J, O'Neil BH. First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors. Clinical Cancer Research 2019, 25: 6309-6319. PMID: 31420359, DOI: 10.1158/1078-0432.ccr-19-0578.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsCohort StudiesDrug Administration ScheduleFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNauseaNeoplasmsPyridonesRecurrenceSulfonamidesConceptsTreatment-emergent adverse eventsDose escalationSolid tumorsStable diseaseSafety profileProstate cancerCommon grade 3/4 treatment-emergent adverse eventsGrade 3/4 treatment-emergent adverse eventsHuman studiesMost common treatment-emergent adverse eventsCommon treatment-emergent adverse eventsMedian progression-free survivalTolerable safety profilePhase II doseAdvanced solid tumorsProgression-free survivalRefractory solid tumorsPreliminary antitumor activityMalignant solid tumorsAminotransferase elevationEvaluable patientsDose expansionExpansion cohortGastrointestinal bleedAdverse events
2009
Phase I Dose-Escalation and Pharmacokinetic Study of Dasatinib in Patients with Advanced Solid Tumors
Demetri G, Russo P, MacPherson I, Wang D, Morgan J, Brunton V, Paliwal P, Agrawal S, Voi M, Evans T. Phase I Dose-Escalation and Pharmacokinetic Study of Dasatinib in Patients with Advanced Solid Tumors. Clinical Cancer Research 2009, 15: 6232-6240. PMID: 19789325, DOI: 10.1158/1078-0432.ccr-09-0224.Peer-Reviewed Original ResearchConceptsDose-limiting toxicitySolid tumorsHematologic toxicityFrequent treatment-related toxicitiesDurable stable diseaseGrade 2 proteinuriaGrade 2 rashGrade 3 fatigueGrade 3 hypocalcemiaGrade 3 lethargyGrade 3 nauseaI Dose-EscalationLess hematologic toxicityGrade 3 rashObjective tumor responsePhase II doseTreatment-related toxicityAdvanced solid tumorsDose-escalation studyMetastatic solid tumorsStandard therapy existsNontreatment daysStable diseaseDaily dosingStandard therapy
2001
Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients
Blum J, Dieras V, Russo P, Horton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients. Cancer 2001, 92: 1759-1768. PMID: 11745247, DOI: 10.1002/1097-0142(20011001)92:7<1759::aid-cncr1691>3.0.co;2-a.Peer-Reviewed Original ResearchConceptsMetastatic breast carcinomaTreatment-related adverse eventsHand-foot syndromeBreast carcinomaAdverse eventsGrade 3 treatment-related adverse eventsCommon treatment-related adverse eventsResponse rateGrade 4 adverse eventsMetastatic breast carcinoma patientsPrevious chemotherapy regimensPrior anthracycline chemotherapyTreatment-related deathsPhase II studyPhase II trialBreast carcinoma patientsSubgroup of patientsOverall response rateCurrent multicenterFluoropyrimidine carbamateOral capecitabineAnthracycline chemotherapyChemotherapy regimensII trialTaxane therapy
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 ResearchMeSH KeywordsAdenocarcinomaAdultAgedAntineoplastic AgentsColorectal NeoplasmsDrug Administration ScheduleFemaleHumansIndazolesIntercalating AgentsLeukopeniaMaleMiddle AgedConceptsAdvanced 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
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 ResearchMeSH KeywordsAcridinesAdultAgedAged, 80 and overAntineoplastic AgentsCarcinomaColorectal NeoplasmsDrug Administration ScheduleFemaleHumansLeukopeniaMaleMiddle AgedPyrazolesSafetyTreatment OutcomeConceptsColorectal 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
1996
Preclinical antitumor activity of CI-994
LoRusso P, Demchik L, Foster B, Knight J, Bissery M, Polin L, Leopold W, Corbett T. Preclinical antitumor activity of CI-994. Investigational New Drugs 1996, 14: 349-356. PMID: 9157069, DOI: 10.1007/bf00180810.Peer-Reviewed Original ResearchConceptsCI-994Prolonged administrationMammary adenocarcinomaClinical phase I trialColon adenocarcinomaPhase I trialHuman xenograft tumor modelsDays of administrationIndividual dosesPancreatic ductal adenocarcinomaPreclinical antitumor activityShort-term therapyLower drug dosesXenograft tumor modelHigher individual dosesI trialOsteogenic sarcomaDuctal adenocarcinomaNovel antitumor agentsDrug dosesAdenocarcinomaSolid tumorsTotal doseGross toxicityTumor model
1995
Phase I clinical trial of pyrazoloacridine NSC366140 (PD115934).
LoRusso P, Foster B, Poplin E, McCormick J, Kraut M, Flaherty L, Heilbrun L, Valdivieso M, Baker L. Phase I clinical trial of pyrazoloacridine NSC366140 (PD115934). Clinical Cancer Research 1995, 1: 1487-93. PMID: 9815948.Peer-Reviewed Original ResearchMeSH KeywordsAcridinesAdultAgedAntineoplastic AgentsDrug Administration ScheduleFemaleHumansInfusions, IntravenousLeukopeniaMaleMiddle AgedNauseaNeoplasmsPyrazolesVomitingConceptsGrade IV toxicityStarting doseDose escalationClinical trialsPhase I clinical trialNext dose escalationAcceptable toxicity profilePhase II trialDose-limiting toxicityPeak plasma levelsPre-clinical efficacyMultidrug-resistant tumor cellsMurine solid tumorsII trialTreatment coursePlasma levelsGrade IInterpatient variationIntermediate dosePreclinical characteristicsToxicity profilePharmacokinetic parametersDose levelsSolid tumorsTotal dosePhase I trial of Adozelesin using the treatment schedule of daily × 5 every 3 weeks
Foster B, LoRusso P, Poplin E, Zalupski M, Valdivieso M, Wozniak A, Flaherty L, Kasunic D, Earhart R, Baker L. Phase I trial of Adozelesin using the treatment schedule of daily × 5 every 3 weeks. Investigational New Drugs 1995, 13: 321-326. PMID: 8824350, DOI: 10.1007/bf00873138.Peer-Reviewed Original ResearchConceptsMinute IV infusionTreatment scheduleM2/dayIV infusionPhase II starting doseRefractory soft tissue sarcomasConsecutive daysPhase IUnique alkylating agentRefractory solid tumorsPhase I trialSoft tissue sarcomasAdditional phase IPreclinical toxicology studiesBroad antitumor activityPotent synthetic analogsAnaphylactoid syndromeStarting doseI trialPartial responseAntitumor responseCumulative myelosuppressionTissue sarcomasTherapeutic dosesCytotoxic treatment
1989
Activity of batracylin (NSC-320846) against solid tumors of mice
Mucci-LoRusso P, Polin L, Bissery M, Valeriote F, Plowman J, Luk G, Corbettv T. Activity of batracylin (NSC-320846) against solid tumors of mice. Investigational New Drugs 1989, 7: 295-306. PMID: 2557298, DOI: 10.1007/bf00173759.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAnimalsAntineoplastic AgentsCarcinoma, Intraductal, NoninfiltratingCell SurvivalCells, CulturedColonic NeoplasmsDrug Administration ScheduleDrug Screening Assays, AntitumorHumansMammary Neoplasms, ExperimentalMiceMice, Inbred StrainsNeoplasms, ExperimentalPancreatic NeoplasmsQuinazolinesTumor Cells, Cultured5-Fluorouracil containing combinations in murine tumor systems
Corbett T, Bissery M, Mucci-LoRusso P, Polin L. 5-Fluorouracil containing combinations in murine tumor systems. Investigational New Drugs 1989, 7: 37-49. PMID: 2661481, DOI: 10.1007/bf00178190.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntineoplastic Combined Chemotherapy ProtocolsDrug Administration ScheduleFluorouracilMiceNeoplasms, Experimental