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
A phase 1 study of the safety, pharmacokinetics and pharmacodynamics of escalating doses followed by dose expansion of the selective inhibitor of nuclear export (SINE) selinexor in Asian patients with advanced or metastatic malignancies
Ho J, Heong V, Yong W, Soo R, Chee C, Wong A, Sundar R, Thian Y, Gopinathan A, Pang M, Koe P, Jeraj S, Soe P, Soe M, Tang T, Ng M, Tai D, Tan T, Xu H, Chang H, Landesman Y, Shah J, Shacham S, Lee S, Tan D, Goh B, Tan D. A phase 1 study of the safety, pharmacokinetics and pharmacodynamics of escalating doses followed by dose expansion of the selective inhibitor of nuclear export (SINE) selinexor in Asian patients with advanced or metastatic malignancies. Therapeutic Advances In Medical Oncology 2022, 14: 17588359221087555. PMID: 35432603, PMCID: PMC9008867, DOI: 10.1177/17588359221087555.Peer-Reviewed Original ResearchPhase 1 studyAsian patientsMetastatic malignancyMedian t<sub>max</sub> wasGrade 3 adverse eventsNCI Common Terminology CriteriaRecommended phase 2 doseAsian patient cohortContinuous dosing regimensGrade 3 fatiguePhase 2 doseThymic carcinoma patientsDose-escalation designCommon Terminology CriteriaInhibitor of nuclear exportCytoplasmic localization of p27Dose expansionComplete responseHodgkin lymphomaExpansion cohortLymphoma patientsPartial responseDrug holidayEscalation designPharmacodynamic assessments
2020
Safety and tolerability of oxaliplatin based pressurized intraperitoneal aerosol chemotherapy (PIPAC) for patients with peritoneal carcinomatosis: A phase I dose-finding study in Asian patients.
Sundar R, Kim G, Tan H, Wang L, Chue K, Tai C, Teo S, Jang C, Chee C, Lieske B, Chee C, Shabbir A, So J, Yong W. Safety and tolerability of oxaliplatin based pressurized intraperitoneal aerosol chemotherapy (PIPAC) for patients with peritoneal carcinomatosis: A phase I dose-finding study in Asian patients. Journal Of Clinical Oncology 2020, 38: 360-360. DOI: 10.1200/jco.2020.38.4_suppl.360.Peer-Reviewed Original ResearchPressurized intraperitoneal aerosol chemotherapyPeritoneal carcinomatosis indexDose-limiting toxicityHyperthermic intraperitoneal chemotherapyPhase 1 studyDose cohortsAsian patientsDose-escalation phase 1 studyPIPAC administrationsGrade 3 adverse eventsMedian peritoneal carcinomatosis indexPeritoneal carcinomatosis index scoreRecommended phase 2 dosePressurized intraperitoneal aerosolized chemotherapy proceduresFailure of standard therapyPhase I dose-finding studyGastrointestinal primary tumorsHighest dose cohortPhase 2 doseDose-escalation studyIntraperitoneal chemotherapyPeritoneal carcinomatosisEscalation studyPeritoneal metastasisOxaliplatin chemotherapy
2017
First-in-human phase I study of an oral HSP90 inhibitor, TAS-116, in advanced solid tumors.
Yanagitani N, Horiike A, Kitazono S, Ohyanagi F, Kondo S, Shimomura A, Fujiwara Y, Doi T, Kuboki Y, Kawazoe A, Shitara K, Ohno I, Banerji U, Sundar R, Ohkubo S, Huang J, Nishio M, Yamamoto N. First-in-human phase I study of an oral HSP90 inhibitor, TAS-116, in advanced solid tumors. Journal Of Clinical Oncology 2017, 35: 2546-2546. DOI: 10.1200/jco.2017.35.15_suppl.2546.Peer-Reviewed Original ResearchTAS-116Solid tumorsFirst-in-human phase I studyAntitumor activityOral HSP90 inhibitorAccelerated titration designPhase 2 studyPhase I studyPreliminary antitumor activityPhase 1 studyEvidence of target engagementDose expansionFlat doseEscalating dosesDose proportionalityRepeated administrationQD scheduleSafety profileEye disordersIncreased creatinineAdverse eventsTitration designDays administrationNon-purinePatients
2015
127O Phase 1 study of safety and tolerability of selinexor in Asian patients with advanced solid cancers: updated results
Heong V, Koe P, Yong W, Soo R, Chee C, Thian Y, Gopinathan A, Wong A, Sundar R, Ho J, Friedlander S, McCauley D, Choe-Juliak C, Lee S, Goh B, Tan D. 127O Phase 1 study of safety and tolerability of selinexor in Asian patients with advanced solid cancers: updated results. Annals Of Oncology 2015, 26: ix37. DOI: 10.1093/annonc/mdv521.03.Peer-Reviewed Original Research