2025
Dose finding study of CBM588 in combination with nivolumab and ipilimumab in patients with metastatic renal cell carcinoma: A phase I study.
Agarwal R, Ebrahimi H, Zengin Z, Barragán Carrillo R, Dizman N, Zugman M, Jaime-Casas S, Meza L, Li X, Hsu J, Castro D, Mercier B, Lee P, Takahashi M, Tripathi A, Dorff T, Caporaso G, Lee K, Pal S, Chehrazi-Raffle A. Dose finding study of CBM588 in combination with nivolumab and ipilimumab in patients with metastatic renal cell carcinoma: A phase I study. Journal Of Clinical Oncology 2025, 43: tps611-tps611. DOI: 10.1200/jco.2025.43.5_suppl.tps611.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaImmune checkpoint inhibitorsProgression-free survivalMaximum tolerated dosePhase I studyRenal cell carcinomaDose levelsCell carcinomaClinical outcomesEfficacy of immune checkpoint inhibitorsMetastatic renal cell carcinoma patientsModulation of immune pathwaysImmune checkpoint inhibitor therapyStandard-of-care treatmentIMDC risk groupsPlanned dose levelsCombination of nivolumabDose-limiting toxicityDose-escalation designDose-escalation studyECOG performance statusDose-finding studyGut microbiomeCheckpoint inhibitorsDose escalation
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
2021
A Dose-finding Study Followed by a Phase II Randomized, Placebo-controlled Trial of Chemoradiotherapy With or Without Veliparib in Stage III Non–small-cell Lung Cancer: SWOG 1206 (8811)
Argiris A, Miao J, Cristea MC, Chen AM, Sands JM, Decker RH, Gettinger SN, Daly ME, Faller BA, Albain KS, Yanagihara RH, Garland LL, Byers LA, Wang D, Koczywas M, Redman MW, Kelly K, Gandara DR. A Dose-finding Study Followed by a Phase II Randomized, Placebo-controlled Trial of Chemoradiotherapy With or Without Veliparib in Stage III Non–small-cell Lung Cancer: SWOG 1206 (8811). Clinical Lung Cancer 2021, 22: 313-323.e1. PMID: 33745865, PMCID: PMC8562492, DOI: 10.1016/j.cllc.2021.02.009.Peer-Reviewed Original ResearchConceptsProgression-free survivalDose-limiting toxicityGrade 3 esophagitisPhase II partCell lung cancerLung cancerStage IIIPARP inhibitorsConcurrent weekly carboplatinEarly study closurePhase II RandomizedTrial of chemoradiotherapyDose-finding studyPhase I partStandard of careAdjuvant immunotherapyConsolidation carboplatinEligible patientsVeliparib doseWeekly carboplatinThoracic radiotherapyOverall survivalPlacebo armStudy closurePredictive biomarkers
2020
Personalized Connectome Mapping to Guide Targeted Therapy and Promote Recovery of Consciousness in the Intensive Care Unit
Edlow B, Barra M, Zhou D, Foulkes A, Snider S, Threlkeld Z, Chakravarty S, Kirsch J, Chan S, Meisler S, Bleck T, Fins J, Giacino J, Hochberg L, Solt K, Brown E, Bodien Y. Personalized Connectome Mapping to Guide Targeted Therapy and Promote Recovery of Consciousness in the Intensive Care Unit. Neurocritical Care 2020, 33: 364-375. PMID: 32794142, PMCID: PMC8336723, DOI: 10.1007/s12028-020-01062-7.Peer-Reviewed Original ResearchConceptsIntensive care unitPromote recovery of consciousnessRecovery of consciousnessIntravenous methylphenidateEarly recovery of consciousnessPromote early recoveryPhase 2aDrug-related adverse eventsCare unitAscending arousal networkEscalating daily dosesHighest tolerated doseAcute severe traumatic brain injuryDose-finding studyOutcome measuresBrain injurySerum half-lifeMaximal serum concentrationPrimary outcome measureWithdrawal of life-sustaining therapyDrug’s pharmacodynamic propertiesSecondary outcome measuresMagnetic resonance imagingOpen-labelPharmacodynamic criteriaA phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with metastatic colorectal cancer receiving FOLFOX chemotherapy and bevacizumab.
Noonan A, Lustberg M, Schnell P, Hays J, Jin N, Abushahin L, Malalur P, Roychowdhury S, Elkhatib R, Chen H, Al Mutar S, Sparreboom A, Hu S. A phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with metastatic colorectal cancer receiving FOLFOX chemotherapy and bevacizumab. Journal Of Clinical Oncology 2020, 38: tps12125-tps12125. DOI: 10.1200/jco.2020.38.15_suppl.tps12125.Peer-Reviewed Original ResearchOxaliplatin-induced peripheral neuropathyOxaliplatin-induced neuropathyOrganic cation transporter 2Peripheral neuropathyColorectal cancerChronic oxaliplatin-induced peripheral neuropathyStage IV colorectal cancerRat dorsal root gangliaOxaliplatin-induced neurotoxicityPharmacokinetics of oxaliplatinPhase 2 doseMetastatic colorectal cancerPhase 1b trialDose-finding studyDorsal root gangliaAddition of dasatinibQuality of lifeSmall molecule kinase inhibitorsFOLFOX chemotherapyOral dasatinibBevacizumab therapyRoot gangliaSerum biomarkersIntermittent doseRat model
2019
S1206: A dose-finding study followed by a phase II randomized placebo-controlled trial of chemoradiotherapy (CRT) with or without veliparib in stage III non-small cell lung cancer (NSCLC).
Argiris A, Miao J, Cristea M, Chen A, Sands J, Decker R, Gettinger S, Daly M, Faller B, Albain K, Yanagihara R, Garland L, Byers L, Wang D, Koczywas M, Redman M, Kelly K, Gandara D. S1206: A dose-finding study followed by a phase II randomized placebo-controlled trial of chemoradiotherapy (CRT) with or without veliparib in stage III non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2019, 37: 8523-8523. DOI: 10.1200/jco.2019.37.15_suppl.8523.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalStage III non-small cell lung cancerAdverse eventsG3 anemiaG3 thrombocytopeniaOverall survivalUnresectable stage III non-small cell lung cancerPARP inhibitorsG3 adverse eventsG3 oral mucositisG3-4 neutropeniaG4 adverse eventsPhase II dosePlacebo-controlled trialCell lung cancerDose-finding studyPhase I partPhase IIBackbone regimenConsolidation carboplatinEvaluable patientsG3 fatigueG3 nauseaG3 neutropeniaPhase IB/II Randomized Study of FOLFIRINOX Plus Pegylated Recombinant Human Hyaluronidase Versus FOLFIRINOX Alone in Patients With Metastatic Pancreatic Adenocarcinoma: SWOG S1313
Ramanathan RK, McDonough SL, Philip PA, Hingorani SR, Lacy J, Kortmansky JS, Thumar J, Chiorean EG, Shields AF, Behl D, Mehan PT, Gaur R, Seery T, Guthrie KA, Hochster HS. Phase IB/II Randomized Study of FOLFIRINOX Plus Pegylated Recombinant Human Hyaluronidase Versus FOLFIRINOX Alone in Patients With Metastatic Pancreatic Adenocarcinoma: SWOG S1313. Journal Of Clinical Oncology 2019, 37: jco.18.01295. PMID: 30817250, PMCID: PMC6494359, DOI: 10.1200/jco.18.01295.Peer-Reviewed Original ResearchConceptsMetastatic pancreatic cancerMedian overall survivalCombination armOverall survivalHazard ratioControl armPhase II open-label studyTreatment-related grade 3Adequate organ functionPhase II dosageOpen-label studyPrimary end pointMetastatic pancreatic adenocarcinomaOS hazard ratioHA statusDose-finding studyInterim futility analysisRecombinant human hyaluronidaseEnoxaparin prophylaxisThromboembolic eventsPerformance statusProlong survivalRandomized studyFutility analysisGood PS
2017
Randomized, double‐blind, placebo‐controlled dose‐finding study of the dipeptidyl peptidase‐4 inhibitor linagliptin in pediatric patients with type 2 diabetes
Tamborlane WV, Laffel LM, Weill J, Gordat M, Neubacher D, Retlich S, Hettema W, Hoesl CE, Kaspers S, Marquard J. Randomized, double‐blind, placebo‐controlled dose‐finding study of the dipeptidyl peptidase‐4 inhibitor linagliptin in pediatric patients with type 2 diabetes. Pediatric Diabetes 2017, 19: 640-648. PMID: 29171139, DOI: 10.1111/pedi.12616.Peer-Reviewed Original ResearchConceptsDPP-4 inhibitionDipeptidyl peptidase-4 inhibitor linagliptinType 2 diabetesInhibitor linagliptinAdult patientsPediatric patientsPlacebo-controlled dose-finding studyDrug-related adverse eventsPrimary efficacy endpointParallel-group studyWeeks of treatmentDose-finding studyDose-dependent reductionEfficacy endpointMean HbA1cAdverse eventsFPG levelsTrough levelsClinical efficacySafety profilePlasma glucosePharmacodynamic endpointsStudy populationPatientsLinagliptin
2015
Phase I dose-finding study of the gamma secretase inhibitor PF-03084014 (PF-4014) in combination with docetaxel in patients (pts) with advanced triple-negative breast cancer (TNBC).
Curigliano G, Aftimos P, Dees E, LoRusso P, Pegram M, Awada A, Huang B, Cesari R, Jiang Y, Shaik M, Kern K, Locatelli M. Phase I dose-finding study of the gamma secretase inhibitor PF-03084014 (PF-4014) in combination with docetaxel in patients (pts) with advanced triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2015, 33: 1068-1068. DOI: 10.1200/jco.2015.33.15_suppl.1068.Peer-Reviewed Original Research
2013
First-in-human dose-finding study of the ALK/EGFR inhibitor AP26113 in patients with advanced malignancies: Updated results.
Camidge D, Bazhenova L, Salgia R, Weiss G, Langer C, Shaw A, Narasimhan N, Dorer D, Rivera V, Zhang J, Clackson T, Haluska F, Gettinger S. First-in-human dose-finding study of the ALK/EGFR inhibitor AP26113 in patients with advanced malignancies: Updated results. Journal Of Clinical Oncology 2013, 31: 8031-8031. DOI: 10.1200/jco.2013.31.15_suppl.8031.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsAdverse eventsAdvanced malignanciesCommon grade 3/4 treatment-related adverse eventsGrade 3/4 treatment-related adverse eventsEGFR-TKI resistant NSCLCNon-small cell lung cancerTreatment-related adverse eventsALK tyrosine kinase inhibitorsPhase I/IINovel tyrosine kinase inhibitorEGFR tyrosine kinase inhibitorsDose finding phaseGrade 4 dyspneaTKI-resistant NSCLCPhase II doseFollow-up scanCell lung cancerDose-finding studyAge 60 yrAnaplastic lymphoma kinaseAnti-tumor activityEpidermal growth factor receptorGrowth factor receptorStable disease
2012
Phase I, open-label study of olaparib plus cisplatin in patients with advanced solid tumors.
Balmaña J, Tung N, Isakoff S, Graña B, Ryan P, Rafi R, Tracy M, Winer E, Baselga J, Garber J. Phase I, open-label study of olaparib plus cisplatin in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 1009-1009. DOI: 10.1200/jco.2012.30.15_suppl.1009.Peer-Reviewed Original ResearchAdvanced solid tumorsHematologic AEsEvaluable ptsMonotherapy phaseDose reductionSolid tumorsAntitumor activityOpen-label studyDose-limiting toxicityCisplatin-related toxicityDose-finding studyDrug-related deathsOral PARP inhibitorLong respondersOlaparib capsulesNeoadjuvant settingPrior regimensStable diseaseDurable responsesObjective responsePeritoneal cancerTherapy cyclesMedian numberBreast cancerTreatment cycles
2010
234 A phase 1, open-label, dose-finding study to assess the safety and tolerability of U3 1287 (AMG 888), a human monoclonal antibody targeting HER3 in patients with advanced solid tumors
LoRusso P, Keedy V, Yee L, Oliveira M, Rizvi N, Berlin J, Jin X, Hettmann T, Copigneaux C, Beaupre D. 234 A phase 1, open-label, dose-finding study to assess the safety and tolerability of U3 1287 (AMG 888), a human monoclonal antibody targeting HER3 in patients with advanced solid tumors. European Journal Of Cancer Supplements 2010, 8: 76. DOI: 10.1016/s1359-6349(10)71939-x.Peer-Reviewed Original Research
2007
Safety, Pharmacokinetics, and Efficacy of AMG 706, an Oral Multikinase Inhibitor, in Patients With Advanced Solid Tumors
Rosen LS, Kurzrock R, Mulay M, Van Vugt A, Purdom M, Ng C, Silverman J, Koutsoukos A, Sun YN, Bass MB, Xu RY, Polverino A, Wiezorek JS, Chang DD, Benjamin R, Herbst RS. Safety, Pharmacokinetics, and Efficacy of AMG 706, an Oral Multikinase Inhibitor, in Patients With Advanced Solid Tumors. Journal Of Clinical Oncology 2007, 25: 2369-2376. PMID: 17557949, DOI: 10.1200/jco.2006.07.8170.Peer-Reviewed Original ResearchConceptsMaximum-tolerated doseAMG 706Advanced solid tumorsSolid tumorsAdvanced refractory solid tumorsRefractory advanced solid tumorsVascular endothelial growth factor receptor 1Frequent adverse eventsRefractory solid tumorsDose-proportional mannerFactor receptorDose-finding studyOral multikinase inhibitorStudy of patientsPlacental growth factorGrowth factor receptor 1Platelet-derived growth factor receptorFactor receptor 1Stem cell factor receptorGrowth factor receptorStable diseaseKinase domain receptorAdverse eventsPartial responseProgressive disease
2006
O-283 Comparative potency of anastrozole to suppress estradiol levels in breast cancer patients undergoing controlled ovarian stimulation prior to IVF: A pilot dose-finding study
Azim A, Costantini-Ferrando M, Lostritto K, Oktay K. O-283 Comparative potency of anastrozole to suppress estradiol levels in breast cancer patients undergoing controlled ovarian stimulation prior to IVF: A pilot dose-finding study. Fertility And Sterility 2006, 86: s121-s122. DOI: 10.1016/j.fertnstert.2006.07.322.Peer-Reviewed Original ResearchSafety and antitumor activity of AMG 706 in patients (pts) with thyroid cancer (TC): A subset analysis from a phase 1 dose-finding study
Boughton D, Rosen L, Van Vugt A, Kurzrock R, Eschenberg M, Wiezorek J, Ingram M, Wang D, Stepan D, Herbst R. Safety and antitumor activity of AMG 706 in patients (pts) with thyroid cancer (TC): A subset analysis from a phase 1 dose-finding study. Journal Of Clinical Oncology 2006, 24: 3030-3030. DOI: 10.1200/jco.2006.24.18_suppl.3030.Peer-Reviewed Original ResearchAMG 706Partial responseThyroid cancerStable diseaseAntitumor activityPhase 1 dose-finding studyTreatment-related adverse eventsPhase 2 studyRefractory solid tumorsStage IV diseasePhase 1 studySmall-molecule multi-kinase inhibitorAdvanced thyroid cancerMedullary thyroid cancerDose-finding studyDirect antitumor activityMulti-kinase inhibitorECOG 1Baseline demographicsObjective responseProgressive diseaseAdverse eventsMedian ageMedian timeConfirmation of responseA multicenter, randomized, dose-finding study of gamma intracoronary radiation therapy to inhibit recurrent restenosis after stenting.
Price MJ, Moses JW, Leon MB, Mehran R, Negoita M, Lansky A, Collins M, Giap H, Lin R, Jani S, Steuterman S, Balter S, Dalton J, Lipsztein R, Tripuraneni P, Teirstein PS. A multicenter, randomized, dose-finding study of gamma intracoronary radiation therapy to inhibit recurrent restenosis after stenting. Journal Of Invasive Cardiology 2006, 18: 169-73. PMID: 16732060.Peer-Reviewed Original ResearchConceptsIntracoronary radiation therapyStent restenosisRadiation therapyLesion late lossTarget lesion revascularizationHigh-dose groupDose-finding studySignificant clinical problemBare metal stentsRadiation dose prescriptionHigh radiation doseBinary restenosisLesion revascularizationRecurrent restenosisVessel revascularizationAdverse eventsCoronary interventionRecurrent stenosisComposite endpointRandomized studyDose groupClinical eventsMyocardial infarctionRadiation failureGy group
2004
151 AMG 706 first in human, open-label, dose-finding study evaluating the safety and pharmacokinetics (PK) in subjects with advanced solid tumors
Herbst R, Kurzrock R, Parson M, Benjamin R, Chen L, Ng C, Ingram M, Wong S, Chang D, Rosen L. 151 AMG 706 first in human, open-label, dose-finding study evaluating the safety and pharmacokinetics (PK) in subjects with advanced solid tumors. European Journal Of Cancer Supplements 2004, 2: 48. DOI: 10.1016/s1359-6349(04)80159-9.Peer-Reviewed Original ResearchQuantitative Analysis of Biomarkers Defines an Optimal Biological Dose for Recombinant Human Endostatin in Primary Human Tumors
Davis DW, Shen Y, Mullani NA, Wen S, Herbst RS, O’Reilly M, Abbruzzese JL, McConkey DJ. Quantitative Analysis of Biomarkers Defines an Optimal Biological Dose for Recombinant Human Endostatin in Primary Human Tumors. Clinical Cancer Research 2004, 10: 33-42. PMID: 14734449, DOI: 10.1158/1078-0432.ccr-0736-3.Peer-Reviewed Original ResearchMeSH KeywordsAngiogenesis InhibitorsApoptosisBiomarkersCohort StudiesDiagnostic ImagingDose-Response Relationship, DrugEndostatinsEndothelial CellsHumansHypoxia-Inducible Factor 1, alpha SubunitIn Situ Nick-End LabelingNeoplasmsNeovascularization, PathologicPlatelet Endothelial Cell Adhesion Molecule-1Proto-Oncogene Proteins c-bcl-2Recombinant ProteinsTomography, Emission-ComputedTranscription FactorsConceptsHypoxia-inducible factor-1alphaRecombinant human endostatinMicrovessel densityLaser scanning cytometryTC deathHuman endostatinPhase I dose-finding studyTerminal deoxynucleotidyl transferase-mediated nick end labeling stainingTumor cellsEndothelial cellsTumor-associated endothelial cellsSignificant clinical activityFactor-1alphaRefractory solid tumorsCohort of patientsNick end labeling stainingPhase I trialDose-finding studyTumor microvessel densityTumor blood flowOptimal biological doseEnd labeling stainingWhole tissue sectionsPositron emission tomographyPrimary human tumors
1990
Cyclophosphamide, carmustine, and etoposide with autologous bone marrow transplantation in refractory Hodgkin's disease and non-Hodgkin's lymphoma: a dose-finding study.
Wheeler C, Antin JH, Churchill WH, Come SE, Smith BR, Bubley GJ, Rosenthal DS, Rappaport JM, Ault KA, Schnipper LE. Cyclophosphamide, carmustine, and etoposide with autologous bone marrow transplantation in refractory Hodgkin's disease and non-Hodgkin's lymphoma: a dose-finding study. Journal Of Clinical Oncology 1990, 8: 648-56. PMID: 2313334, DOI: 10.1200/jco.1990.8.4.648.Peer-Reviewed Original ResearchConceptsAutologous bone marrow transplantationMaximum-tolerated doseBone marrow transplantationRelapsed lymphomaComplete responseMarrow transplantationDose levelsVP-16Refractory Hodgkin's diseaseTreatment-related mortalityDose-finding studyAssessable patientsAcceptable toxicityConditioning regimenInterstitial pneumonitisHodgkin's diseaseResidual diseaseHodgkin's lymphomaPatient populationDisease progressionHigh dosePatientsLymphomaDiseaseCBV
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