2024
A Phase II Trial of the WEE1 Inhibitor Adavosertib in SETD2-Altered Advanced Solid Tumor Malignancies (NCI 10170)
Maldonado E, Rathmell W, Shapiro G, Takebe N, Rodon J, Mahalingam D, Trikalinos N, Kalebasty A, Parikh M, Boerner S, Balido C, Krings G, Burns T, Bergsland E, Munster P, Ashworth A, LoRusso P, Aggarwal R. A Phase II Trial of the WEE1 Inhibitor Adavosertib in SETD2-Altered Advanced Solid Tumor Malignancies (NCI 10170). Cancer Research Communications 2024, 4: 1793-1801. PMID: 38920407, PMCID: PMC11264598, DOI: 10.1158/2767-9764.crc-24-0213.Peer-Reviewed Original ResearchSolid tumor malignanciesStable diseaseTumor malignancyAdverse eventsDepth of tumor responseLoss of H3K36me3Median duration of treatmentAdvanced solid tumor malignanciesClear cell renal cell carcinomaMinor tumor regressionsProlonged stable diseaseArchival tumor tissuePhase II studyCell renal cell carcinomaPhase II trialRenal cell carcinomaDuration of treatmentArchival tissue samplesSimon's two-stageTumor responseTumor regressionII trialMedian durationII studySETD2 mutations
2011
MEDI-573 as a novel approach to IGF-1R and IR-A signaling inhibition by blocking IGF ligands: Phase I PK/PD, safety data, and disease linkage studies in breast cancer.
Haluska P, Huang J, Lam B, Liang M, Huang W, LoRusso P, Menefee M, LaVallee T, Yao Y, Viner J. MEDI-573 as a novel approach to IGF-1R and IR-A signaling inhibition by blocking IGF ligands: Phase I PK/PD, safety data, and disease linkage studies in breast cancer. Journal Of Clinical Oncology 2011, 29: 271-271. DOI: 10.1200/jco.2011.29.27_suppl.271.Peer-Reviewed Original ResearchMEDI-573Breast cancerIR-B ratioIGF-1RGlucose levelsPhase Ib/II studyDrug-related SAEsAdvanced solid tumorsDose-escalation trialBreast cancer subsetsFree IGF-1Plasma glucose levelsFavorable PK profileDetermination of MTDPK/PDAdjacent normal tissuesStable diseaseII studyIV infusionAntidrug antibodiesSafety profileInsulin resistanceSignificant changesAcceptable safetyTumor response
2007
A phase I study of BMS-582664 (brivanib alaninate), an oral dual inhibitor of VEGFR and FGFR tyrosine kinases, in combination with full-dose cetuximab in patients (pts) with advanced gastrointestinal malignancies (AGM) who failed prior therapy
Garrett C, Siu L, Giaccone G, El-Khoueiry A, Marshall J, LoRusso P, Velasquez L, Kollia G, He P, Feltquate D. A phase I study of BMS-582664 (brivanib alaninate), an oral dual inhibitor of VEGFR and FGFR tyrosine kinases, in combination with full-dose cetuximab in patients (pts) with advanced gastrointestinal malignancies (AGM) who failed prior therapy. Journal Of Clinical Oncology 2007, 25: 14018-14018. DOI: 10.1200/jco.2007.25.18_suppl.14018.Peer-Reviewed Original ResearchAdvanced gastrointestinal malignanciesFDG-PETColorectal cancerDay 8Phase I dose-escalation studyI dose-escalation studyPre-treatment FDG-PETDual tyrosine kinase inhibitorBilateral pulmonary emboliOral dual inhibitorPO day 1Treatment-related AEsFDG-PET resultsDose-escalation studyTyrosine kinase inhibitorsReproducible imaging modalityPrior therapyExpansion cohortGastrointestinal malignanciesPulmonary emboliDose escalationIntra-subject CVOral prodrugTumor responseTarget lesionsAMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors
Mita A, Wang D, Takimoto C, Malseed E, Nguyen L, Rasmussen E, Storgard C, LoRusso P. AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 14033-14033. DOI: 10.1200/jco.2007.25.18_suppl.14033.Peer-Reviewed Original ResearchDose-limiting toxicityAMG 386Advanced solid tumorsComplete responsePK profilesAdult patientsSolid tumorsMedian age 59.5 yearsAntitumor activityOpen-label studyGemcitabine/cisplatinFurther clinical studiesFormation of antibodiesTumor response dataSerious AEsCancer refractoryFOLFOX-4Stable diseaseProgressive diseaseWeekly administrationTumor responseWeek 16Bladder cancerDisease progressionWeek 8AZD2171 in combination with various anticancer regimens: Follow-up results of a phase I multi-cohort study
Shields A, Heath E, DeLuca P, Pilat M, Wozniak A, Gadgeel S, Puchalski T, Xu J, Liu Q, LoRusso P. AZD2171 in combination with various anticancer regimens: Follow-up results of a phase I multi-cohort study. Journal Of Clinical Oncology 2007, 25: 3544-3544. DOI: 10.1200/jco.2007.25.18_suppl.3544.Peer-Reviewed Original ResearchAnticancer regimensApparent PK interactionsCommon adverse eventsObjective tumor responseAdvanced solid tumorsPotential pharmacokinetic interactionsCell lung cancerMulti-cohort studyNovel study designPK parameter valuesStable diseaseAdverse eventsPartial responsePharmacokinetic interactionsTreatment armsClinical benefitSafety profileLung cancerPK interactionsTumor responseRecent trialsEfficacy dataAZD2171Unexpected toxicitiesCombination treatment
2005
Final results of a phase I study of liposome encapsulated SN-38 (LE-SN38): Safety, pharmacogenomics, pharmacokinetics, and tumor response
Kraut E, Fishman M, Lorusso P, Gordon M, Rubin E, Haas A, Fetterly G, Cullinan P, Dul J, Steinberg J. Final results of a phase I study of liposome encapsulated SN-38 (LE-SN38): Safety, pharmacogenomics, pharmacokinetics, and tumor response. Journal Of Clinical Oncology 2005, 23: 2017-2017. DOI: 10.1200/jco.2005.23.16_suppl.2017.Peer-Reviewed Original ResearchTumor response