2024
CHAPTER-GIST-101: A phase I study of pimitespib combined with imatinib in patients with imatinib-refractory gastrointestinal stromal tumor.
Hirano H, Naito Y, Sundar R, Komatsu Y, Kurokawa Y, Li J, Ozaka M, Iwatsuki M, Chen J, Yen C, Zalcberg J, Roy A, Chen L, Nishida T, Doi T. CHAPTER-GIST-101: A phase I study of pimitespib combined with imatinib in patients with imatinib-refractory gastrointestinal stromal tumor. Journal Of Clinical Oncology 2024, 42: tps97-tps97. DOI: 10.1200/jco.2024.42.23_suppl.tps97.Peer-Reviewed Original ResearchDose-escalation partGastrointestinal stromal tumorsProgression-free survivalDays on/2 daysResistance to IMStromal tumorsImatinib-refractory gastrointestinal stromal tumorsInvestigator-assessed progression-free survivalAdvanced gastrointestinal stromal tumorsKinase-domain mutationsOvercome IM resistanceWeeks on/2 weeksDisease control rateDose-limiting toxicitySecond-line settingDuration of responseMaximum tolerated dosePhase I studyPhase 3 studyPhase 1 studySoft tissue sarcomasHsp90 inhibitorsInhibited tumor growthAnti-tumor activityOverall survival
2022
Selective Internal Radiation Therapy with Yttrium-90 Resin Microspheres Followed by Gemcitabine plus Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Single-Arm Multicenter Clinical Trial
Chan S, Chotipanich C, Choo S, Kwang S, Mo F, Worakitsitisatorn A, Tai D, Sundar R, Ng D, Loke K, Li L, Ng K, Peng Y, Yu S. Selective Internal Radiation Therapy with Yttrium-90 Resin Microspheres Followed by Gemcitabine plus Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Single-Arm Multicenter Clinical Trial. Liver Cancer 2022, 11: 451-459. PMID: 36158588, PMCID: PMC9485918, DOI: 10.1159/000525489.Peer-Reviewed Original ResearchUnresectable intrahepatic cholangiocarcinomaProgression-free survivalSelective internal radiation therapyInternal radiation therapyIntrahepatic cholangiocarcinomaMedian OSRadiation therapyOverall survivalClinical trialsMedian cycle of chemotherapyMedian progression-free survivalResin yttrium-90 microspheresYttrium-90 resin microspheresTreatment-related adverse eventsIntent-to-treat populationResponse rateDisease control rateResponse Evaluation CriteriaYttrium-90 microspheresCycles of chemotherapyWithdrawal of consentMulticenter clinical trialInvestigator-initiated clinical trialStandard gemcitabineStandard chemotherapy
2020
Clinical efficacy and molecular effects of lenvatinib (Len) and letrozole (Let) in hormone receptor-positive (HR+) metastatic breast cancer (MBC).
Lim J, Wong A, Ow S, Ngoi N, Ang Y, Chan G, Eng L, Chong W, Choo J, Lee M, Tan H, Jan Y, Tan K, Sundar R, Tan D, Soo R, Chee C, Yong W, Goh B, Lee S. Clinical efficacy and molecular effects of lenvatinib (Len) and letrozole (Let) in hormone receptor-positive (HR+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2020, 38: 1019-1019. DOI: 10.1200/jco.2020.38.15_suppl.1019.Peer-Reviewed Original ResearchDisease control rateObjective response rateMetastatic breast cancerEffect of lenvatinibDose escalationEndocrine therapyEfficacy dataRecommended phase 2 doseAll-grade toxicitiesPhase 2 doseDose-escalation phaseHormone receptor-positiveDuration of responsePhase Ib/II studyTumor molecular profilingSerial tumor biopsiesAnti-tumor activityMolecular effectsMedian DoRPrior CTPALB2 mutationsProgression-freeExpansion cohortMBC patientsReceptor-positive
2019
A phase Ib/II trial of lenvatinib (len) and letrozole (let) incorporating pharmacodynamics studies in postmenopausal women with hormone receptor positive (HR+) locally advanced/metastatic breast cancer (LABC/MBC).
Lim J, Wong A, Ow S, Eng L, Sundar R, Chan G, Yadav K, Heong V, Tan D, Soo R, Chee C, Yong W, Goh B, Lee S. A phase Ib/II trial of lenvatinib (len) and letrozole (let) incorporating pharmacodynamics studies in postmenopausal women with hormone receptor positive (HR+) locally advanced/metastatic breast cancer (LABC/MBC). Journal Of Clinical Oncology 2019, 37: 1045-1045. DOI: 10.1200/jco.2019.37.15_suppl.1045.Peer-Reviewed Original ResearchDose-limiting toxicityDisease control ratePalmar-plantar erythrodysesthesiaDose reductionBreast cancerDose levelsMechanisms of endocrine resistanceRecommended phase 2 dosePhase 2 doseAdvanced/metastatic breast cancerHR+ breast cancerPhase Ib trialContinuous daily dosingSerial tumor biopsiesAnti-tumor activityStandard of careDose expansionG3 toxicityPrior CTPostmenopausal womenTumor biopsiesEndocrine resistanceDaily doseEstrogen receptorPreclinical studies