2005
A phase I and pharmacokinetic study of VNP40101M, a new alkylating agent, in patients with advanced or metastatic cancer
Murren J, Modiano M, Kummar S, Clairmont C, Egorin M, Chu E, Sznol M. A phase I and pharmacokinetic study of VNP40101M, a new alkylating agent, in patients with advanced or metastatic cancer. Investigational New Drugs 2005, 23: 123-135. PMID: 15744588, DOI: 10.1007/s10637-005-5857-6.Peer-Reviewed Original ResearchConceptsPhase II trialDose levelsII trialVNP40101MGrade 2 adverse eventsIntra-patient dose escalationPre-treated patient populationBroad anti-tumor activityGrade 3 thrombocytopeniaPhase I trialPeak plasma concentrationDose-related toxicityMurine tumor modelsAnti-tumor activityModerate granulocytopeniaAcute headacheStarting doseAdverse eventsI trialMajor toxicityDose escalationFacial flushingPatient populationPlasma concentrationsMetastatic cancer
2003
Phase I and pharmacokinetic study of triapine, a potent ribonucleotide reductase inhibitor, administered daily for five days in patients with advanced solid tumors.
Murren J, Modiano M, Clairmont C, Lambert P, Savaraj N, Doyle T, Sznol M. Phase I and pharmacokinetic study of triapine, a potent ribonucleotide reductase inhibitor, administered daily for five days in patients with advanced solid tumors. Clinical Cancer Research 2003, 9: 4092-100. PMID: 14519631.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityAdverse eventsSafety profilePhase IGrade 3Week scheduleDrug-related adverse eventsGrade 2 adverse eventsGrade 1Common nonhematological toxicitiesGrade 4 leukopeniaSingle-patient cohortsAcceptable safety profileAdvanced solid tumorsDose-escalation phaseHepatic adverse eventsPhase II trialCohort of patientsCumulative urinary recoveryLinear pharmacokinetic behaviorPotent ribonucleotide reductase inhibitorNonhematological toxicitiesII trialMean eliminationStarting dose