1991
A phase i clinical trial of didemnin B
Stewart J, Low J, Roberts J, Blow A. A phase i clinical trial of didemnin B. Cancer 1991, 68: 2550-2554. PMID: 1933801, DOI: 10.1002/1097-0142(19911215)68:12<2550::aid-cncr2820681203>3.0.co;2-q.Peer-Reviewed Original ResearchConceptsM2/dDrug-induced liver dysfunctionPhase I clinical trialPhase II doseHepatic enzyme levelsDose-limiting toxicityComplete tumor responseCastor oil vehicleMurine B16 melanomaDidemnin BBolus scheduleClinical bleedingLiver dysfunctionAdvanced cancerAnaphylactic symptomsTumor responseClinical trialsDrug infusionL1210 growthOil vehicleM5076 sarcomaB16 melanomaDose levelsSporadic elevationsToxicologic tests
1988
Phase I clinical and pharmacokinetic study of trimetrexate using a daily x5 schedule.
Stewart JA, McCormack JJ, Tong W, Low JB, Roberts JD, Blow A, Whitfield LR, Haugh LD, Grove WR, Lopez AJ. Phase I clinical and pharmacokinetic study of trimetrexate using a daily x5 schedule. Cancer Research 1988, 48: 5029-35. PMID: 2970294.Peer-Reviewed Original ResearchConceptsWhite blood cellsM2/dGood performance status patientsMedian white blood cellPhase IDaily x5 schedulePhase II trialPharmacokinetic studyColon 26 tumorMurine i.Nonhematological toxicitiesPlatelet nadirsPrior therapyII trialStarting doseStatus patientsDose escalationTerminal eliminationDose administeredPlatelet toxicityDaily dosesSchedule dependencyPharmacokinetic analysisB16 melanomaDose levels