2021
Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC).
Kim J, Milowsky M, Hahn N, Kwiatkowski D, Morgans A, Davis N, Appleman L, Gupta S, Lara P, Hoffman-Censits J, Quinn D, Shyr Y, LoRusso P, Sklar J, Petrylak D. Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2021, 39: 431-431. DOI: 10.1200/jco.2021.39.6_suppl.431.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaStable diseaseAdverse eventsObjective responseWithdrew consentTSC2 mutationsUrothelial carcinomaTSC1 mutationsTumor samplesCommon adverse eventsMedian overall survivalTreatment-related deathsPhase II studyCentral labOverall response rateDual mTORC1/2 inhibitorUnknown mutational statusCentral confirmationEligible patientsEvaluable patientsMUC patientsRestaging scanII studyPrimary endpointBaseline characteristics
2020
Relationship between hyperphosphatemia with infigratinib (BGJ398) and efficacy in FGFR3 -altered advanced/metastatic urothelial carcinoma (aUC).
Lyou Y, Grivas P, Rosenberg J, Hoffman-Censits J, Quinn D, Petrylak D, Galsky M, Vaishampayan U, De Giorgi U, Gupta S, Burris H, Rearden J, Ye Y, Wang H, Moran S, Daneshmand S, Bajorin D, Pal S. Relationship between hyperphosphatemia with infigratinib (BGJ398) and efficacy in FGFR3 -altered advanced/metastatic urothelial carcinoma (aUC). Journal Of Clinical Oncology 2020, 38: 576-576. DOI: 10.1200/jco.2020.38.6_suppl.576.Peer-Reviewed Original ResearchDisease control rateOverall response rateTreatment lengthFGFR inhibitorsPrior platinum-based chemotherapyClass effectMedian treatment lengthRECIST 1.0 criteriaCommon adverse eventsMetastatic urothelial carcinomaSignificant clinical activityPlatinum-based chemotherapyPhosphate binder sevelamerMutations/fusionsEligible patientsEfficacy outcomesUnacceptable toxicityAdverse eventsFGFR3 alterationsEfficacy findingsUrothelial carcinomaControl ratePharmacodynamic biomarkersDisease progressionClinical activity
2015
Interim results of a randomized phase 2 study of docetaxel with ramucirumab versus docetaxel in second-line advanced or metastatic urothelial carcinoma.
Petrylak D, Tagawa S, Kohli M, Tang S, Zhang H, Hamid O, Kauh J, Walgren R, Chi K. Interim results of a randomized phase 2 study of docetaxel with ramucirumab versus docetaxel in second-line advanced or metastatic urothelial carcinoma. Journal Of Clinical Oncology 2015, 33: 295-295. DOI: 10.1200/jco.2015.33.7_suppl.295.Peer-Reviewed Original ResearchRandomized phase 2 studyMetastatic urothelial carcinomaPhase 2 studyUrothelial carcinomaDisease progressionInterim analysisMetastatic platinum-resistant urothelial carcinomaDisease control rateECOG PS 0ECOG PS 1Investigator-assessed PFSAdvanced urothelial carcinomaCommon adverse eventsFirst-line chemotherapyMedian PFSPlatinum regimenRECIST v1.1Febrile neutropeniaPrimary endpointVisceral metastasesPFS eventsPS 0Unacceptable toxicityAdverse eventsStudy arms
2013
Phase Ib extension study of eribulin mesylate in combination with carboplatin in patients with chemotherapy-naive advanced non-small cell lung cancer (NSCLC).
Raftopoulos H, Aisner J, Kumar K, Goel S, Dittrich C, Jain M, Gopalakrishna P, Salazar P, Jones B, Petrylak D. Phase Ib extension study of eribulin mesylate in combination with carboplatin in patients with chemotherapy-naive advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: e19145-e19145. DOI: 10.1200/jco.2013.31.15_suppl.e19145.Peer-Reviewed Original ResearchAdvanced non-small cell lung cancerNon-small cell lung cancerDisease control rateProgression-free survivalDuration of responseChemo-naïve patientsAdverse eventsOverall survivalEribulin mesylateDay 1Platinum-based doublet chemotherapyOverall objective response rateCarboplatin AUC 6Combination of eribulinCommon adverse eventsObjective response rateUnexpected safety findingsDose-escalation studyCell lung cancerLung cancer cell linesAUC 6Doublet chemotherapyFebrile neutropeniaMeasurable diseaseCancer cell lines