2025
Selinexor plus ruxolitinib in JAK inhibitor treatment-naïve myelofibrosis: SENTRY Phase 3 study design
Mascarenhas J, Maher K, Rampal R, Bose P, Podoltsev N, Hong J, Chai Y, Kye S, Method M, Harrison C. Selinexor plus ruxolitinib in JAK inhibitor treatment-naïve myelofibrosis: SENTRY Phase 3 study design. Future Oncology 2025, 21: 807-813. PMID: 39911057, PMCID: PMC11916360, DOI: 10.1080/14796694.2025.2461393.Peer-Reviewed Original ResearchConceptsJAK inhibitorsNo dose limiting toxicitiesDose-limiting toxicityAbsolute mean changeSpleen volume reductionPlacebo-controlled studyBaseline to weekTreatment of patientsDose expansionDose escalationLimiting toxicitiesDouble-blindPrimary endpointPhase 3 study designXPO1 inhibitorsMean changeRuxolitinibPatientsSelinexorVolume reductionDosePhase 3InhibitorsJAKMyelofibrosis
2017
TAX-TORC: A phase I trial of vistusertib (AZD2014) in combination with weekly paclitaxel with integrated pharmacodynamic (PD) and molecular characterization (MC) studies.
Sundar R, Basu B, Wilson R, Spicer J, Jones R, Krebs M, Brada M, Talbot D, Steele N, Hall E, Tovey H, Carreira S, de Oliveira F, Swales K, Balarajah G, Dawes J, Parmar M, De Bono J, Banerji U. TAX-TORC: A phase I trial of vistusertib (AZD2014) in combination with weekly paclitaxel with integrated pharmacodynamic (PD) and molecular characterization (MC) studies. Journal Of Clinical Oncology 2017, 35: 2571-2571. DOI: 10.1200/jco.2017.35.15_suppl.2571.Peer-Reviewed Original ResearchHigh-grade serous ovarian cancerHigh-grade serous ovarian cancer patientsRecommended phase 2 doseMedian progression free survivalImproving outcomes of patientsPhase 2 doseDose-limiting toxicityDose-escalation partProgression free survivalArchival tumor tissuePhase I trialSerous ovarian cancerOutcomes of patientsLines of treatmentResistance to chemotherapyP-S6K levelsPre-dose levelsPlatelet-rich plasmaWeekly paclitaxelExpansion cohortFree survivalPlatinum therapyATM mutationsLimiting toxicitiesBID PO
2016
Low Levels of NDRG1 in Nerve Tissue Are Predictive of Severe Paclitaxel-Induced Neuropathy
Sundar R, Jeyasekharan A, Pang B, Soong R, Kumarakulasinghe N, Ow S, Ho J, Lim J, Tan D, Wilder-Smith E, Bandla A, Tan S, Asuncion B, Fazreen Z, Hoppe M, Putti T, Poh L, Goh B, Lee S. Low Levels of NDRG1 in Nerve Tissue Are Predictive of Severe Paclitaxel-Induced Neuropathy. PLOS ONE 2016, 11: e0164319. PMID: 27716814, PMCID: PMC5055363, DOI: 10.1371/journal.pone.0164319.Peer-Reviewed Original ResearchConceptsPaclitaxel-induced neuropathySevere neuropathyReceiver Operating CharacteristicNerve tissueDose-limiting toxicityEarly breast cancerSensory peripheral neuropathyArea under the curveBreast cancer patientsIntensity of stainingWeekly paclitaxelSurgical resectionCharcot-Marie-ToothLimiting toxicitiesPredictive biomarkersNerve biopsyPeripheral neuropathyBreast cancerBiomarker strategiesCancer patientsNDRG1 expressionNeuropathyExpression scorePatientsPaclitaxel
2014
Phase Ib/II trial of gemcitabine, cisplatin, plus lenalidomide as first-line therapy for patients with metastatic urothelial carcinoma.
Tsao C, Agarwal N, Apolo A, Lee K, Godbold J, Oh W, Galsky M. Phase Ib/II trial of gemcitabine, cisplatin, plus lenalidomide as first-line therapy for patients with metastatic urothelial carcinoma. Journal Of Clinical Oncology 2014, 32: 321-321. DOI: 10.1200/jco.2014.32.4_suppl.321.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaDose-limiting toxicityPhase II portionDay 1Dose delaysDose reductionUrothelial carcinomaDose of lenalidomidePhase 1b portionPhase Ib portionPhase Ib/II trialGrade 4 neutropeniaProgression-free survivalEfficacy of gemcitabineCisplatin-based chemotherapyFirst-line therapyDose escalation rulesDose delays/reductionsStable diseasePartial responseStandard chemotherapyTumor responseCytotoxic chemotherapyLimiting toxicitiesSlow accrual
2013
Phase I trial of temsirolimus (TEM) and perifosine (PER) for recurrent or progressive malignant glioma (MG).
Kaley T, Pentsova E, Omuro A, Mellinghoff I, Nolan C, Gavrilovic I, DeAngelis L, Lacouture M, Holland E, Lassman A. Phase I trial of temsirolimus (TEM) and perifosine (PER) for recurrent or progressive malignant glioma (MG). Journal Of Clinical Oncology 2013, 31: 2095-2095. DOI: 10.1200/jco.2013.31.15_suppl.2095.Peer-Reviewed Original ResearchRecurrent malignant gliomaPhase I trialMalignant gliomasI trialDose level 3Dose level 7Dose of temsirolimusMedian age 52Progressive malignant gliomaSynergistic anti-tumor effectPI3K/Akt/mTOR signalingAkt/mTOR SignalingMTOR inhibitor temsirolimusAnti-tumor effectsPotential therapeutic targetKPS 80Prior RTPrior therapyLimiting toxicitiesIntracerebral hemorrhageCombined therapyCombination therapyPreclinical dataLung infectionCell cycle arrest
2012
Targeting hyaluronan (HA) in tumor stroma: A phase I study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of pegylated hyaluronidase (PEGPH20) in patients with solid tumors.
Borad M, Ramanathan R, Bessudo A, LoRusso P, Shepard H, Maneval D, Jiang P, Zhu J, Frost G, Infante J. Targeting hyaluronan (HA) in tumor stroma: A phase I study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of pegylated hyaluronidase (PEGPH20) in patients with solid tumors. Journal Of Clinical Oncology 2012, 30: 2579-2579. DOI: 10.1200/jco.2012.30.15_suppl.2579.Peer-Reviewed Original ResearchMusculoskeletal eventsSolid tumorsFDG-PETDCE-MRITumor biopsiesTumor perfusionInterstitial fluid pressureOngoing phase 1 studiesTreatment-refractory solid tumorsWeekly dosing scheduleDose limiting toxicitiesPhase 1 studyWeeks of dosingEfficacy of chemotherapyTerminal half lifeFDG-PET imagesOral dexamethasoneTumor hyaluronanCytotoxic chemotherapyMost patientsDosing schedulesLimiting toxicitiesPoor prognosisSystemic exposureHA depletion
This site is protected by hCaptcha and its Privacy Policy and Terms of Service apply