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
PIPAC-OX: A Phase I Study of Oxaliplatin-Based Pressurized Intraperitoneal Aerosol Chemotherapy in Patients with Peritoneal Metastases
Kim G, Tan L, Sundar R, Lieske B, Chee C, Ho J, Shabbir A, Babak M, Ang W, Goh B, Yong W, Wang L, So J. PIPAC-OX: A Phase I Study of Oxaliplatin-Based Pressurized Intraperitoneal Aerosol Chemotherapy in Patients with Peritoneal Metastases. Clinical Cancer Research 2020, 27: 1875-1881. PMID: 33148667, DOI: 10.1158/1078-0432.ccr-20-2152.Peer-Reviewed Original ResearchConceptsPressurized intraperitoneal aerosol chemotherapyPressurized intraperitoneal aerosolized chemotherapy proceduresPeritoneal cancer indexPeritoneal metastasisAerosol chemotherapyMedian peritoneal cancer indexPeritoneal Regression Grading ScoreRecommended phase II doseGrade 2 pancreatitisHighest-dose cohortPhase II doseDose-limiting toxicityFirst-line chemotherapyDose-escalation designTreat peritoneal metastasisPhase I studyImprove drug distributionII doseStable diseaseCancer indexMedian ageCohort expansionGastrointestinal tumorsPharmacokinetic analysisDose levels