Pharmacokinetics and safety of DTS-108, a human oligopeptide bound to SN-38 with an esterase-sensitive cross-linker in patients with advanced malignancies: a Phase I study

References

• MathijssenRHvan AlphenRJVerweijJClinical pharmacokinetics and metabolism of irinotecan (CPT-11)Clin Cancer Res2001782182219411489791
   PubMed Web of Science ®Google Scholar
• Garcia-CarboneroRSupkoJGCurrent perspectives on the clinical experience, pharmacology, and continued development of the camptothecinsClin Cancer Res20028364166111895891
   PubMed Web of Science ®Google Scholar
• GuptaELestingiTMMickRRamirezJVokesEERatainMJMetabolic fate of irinotecan in humans: correlation of glucuronidation with diarrheaCancer Res19945414372337258033091
   PubMed Web of Science ®Google Scholar
• ArakiEIshikawaMIigoMKoideTItabashiMHoshiARelationship between development of diarrhea and the concentration of SN-38, an active metabolite of CPT-11, in the intestine and the blood plasma of athymic mice following intraperitoneal administration of CPT-11Jpn J Cancer Res19938466977028340259
   PubMedGoogle Scholar
• KudohSFukuokaMMasudaNRelationship between the pharmacokinetics of irinotecan and diarrhea during combination chemotherapy with cisplatinJpn J Cancer Res19958644064137775263
   PubMedGoogle Scholar
• JaxelCKohnKWWaniMCWallMEPommierYStructure-activity study of the actions of camptothecin derivatives on mammalian topoisomerase I: evidence for a specific receptor site and a relation to antitumor activityCancer Res1989496146514692538227
   PubMed Web of Science ®Google Scholar
• BisseryMCVrignaudPLavelleFChabotGGExperimental antitumor activity and pharmacokinetics of the camptothecin analog irinotecan (CPT-11) in miceAnticancer Drugs1996744374608826613
   PubMedGoogle Scholar
• VanhoeferUHarstrickAAchterrathWCaoSSeeberSRustumYMIrinotecan in the treatment of colorectal cancer: clinical overviewJ Clin Oncol20011951501151811230497
   PubMed Web of Science ®Google Scholar
• SlatterJGSuPSamsJPSchaafLJWienkersLCBioactivation of the anticancer agent CPT-11 to SN-38 by human hepatic microsomal carboxylesterases and the in vitro assessment of potential drug interactionsDrug Metab Dispos19972510115711649321519
   PubMed Web of Science ®Google Scholar
• IyerLHallDDasSPhenotype-genotype correlation of in vitro SN-38 (active metabolite of irinotecan) and bilirubin glucuronidation in human liver tissue with UGT1A1 promoter polymorphismClin Pharmacol Ther199965557658210340924
   PubMed Web of Science ®Google Scholar
• IyerLKingCDWhitingtonPFGenetic predisposition to the metabolism of irinotecan (CPT-11). Role of uridine diphosphate glucuronosyltransferase isoform 1A1 in the glucuronidation of its active metabolite (SN-38) in human liver microsomesJ Clin Invest199810148478549466980
   PubMed Web of Science ®Google Scholar
• SenterPDBeamKSMixanBWahlAFIdentification and activities of human carboxylesterases for the activation of CPT-11, a clinically approved anticancer drugBioconjug Chem20011261074108011716702
   PubMed Web of Science ®Google Scholar
• HartmannJTLippHPCamptothecin and podophyllotoxin derivatives: inhibitors of topoisomerase I and II – mechanisms of action, pharmacokinetics and toxicity profileDrug Saf200629320923016524321
   PubMedGoogle Scholar
• AlimontiAGelibterAPaveseINew approaches to prevent intestinal toxicity of irinotecan-based regimensCancer Treat Rev200430655556215325035
   PubMedGoogle Scholar
• XieRMathijssenRHSparreboomAVerweijJKarlssonMOClinical pharmacokinetics of irinotecan and its metabolites in relation with diarrheaClin Pharmacol Ther200272326527512235447
   PubMed Web of Science ®Google Scholar
• ShimadaYYoshinoMWakuiAPhase II study of CPT-11, a new camptothecin derivative, in metastatic colorectal cancer. CPT-11 Gastrointestinal Cancer Study GroupJ Clin Oncol19931159099138487053
   PubMed Web of Science ®Google Scholar
• FukuokaMNiitaniHSuzukiAA phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small-cell lung cancerJ Clin Oncol199210116201309380
   PubMedGoogle Scholar
• GoncalvesEde CostaLAbigergesDArmandJPA new enkephalinase inhibitor as an alternative to loperamide in the prevention of diarrhea induced by CPT-11J Clin Oncol199513821442146
   Google Scholar
• StringerAMGibsonRJLoganRMIrinotecan-induced mucositis is associated with changes in intestinal mucinsCancer Chemother Pharmacol200964112313218998135
   PubMedGoogle Scholar
• TakasunaKHagiwaraTWatanabeKOptimal antidiarrhea treatment for antitumor agent irinotecan hydrochloride (CPT-11)-induced delayed diarrheaCancer Chemother Pharmacol200658449450316437251
   PubMedGoogle Scholar
• Meyer-LosicFNicolazziCQuinoneroJDTS-108, a novel peptidic prodrug of SN38: in vivo efficacy and toxicokinetic studiesClin Cancer Res20081472145215318381956
   PubMed Web of Science ®Google Scholar
• De CoupadeCFittipaldiAChagnasVNovel human-derived cell-penetrating peptides for specific subcellular delivery of therapeutic biomoleculesBiochem J2005390Pt 240741815859953
   PubMed Web of Science ®Google Scholar
• TherassePArbuckSGEisenhauerEANew guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of CanadaJ Natl Cancer Inst200092320521610655437
   PubMed Web of Science ®Google Scholar
• SimonRFreidlinBRubinsteinLArbuckSGCollinsJChristianMCAccelerated titration designs for phase I clinical trials in oncologyJ Natl Cancer Inst19978915113811479262252
   PubMed Web of Science ®Google Scholar
• EisenhauerEAO’DwyerPJChristianMHumphreyJSPhase I clinical trial design in cancer drug developmentJ Clin Oncol200018368469210653884
   PubMed Web of Science ®Google Scholar
• ChabotGGClinical pharmacokinetics of irinotecanClin Pharmacokinet19973342452599342501
   PubMed Web of Science ®Google Scholar
• ArmandJPDucreuxMMahjoubiMCPT-11 (irinotecan) in the treatment of colorectal cancerEur J Cancer199531A7–8128312877577037
   PubMedGoogle Scholar
• RameshMAhlawatPSrinivasNRIrinotecan and its active metabolite, SN-38: review of bioanalytical methods and recent update from clinical pharmacology perspectivesBiomed Chromatogr201024110412319852077
   PubMed Web of Science ®Google Scholar
• YaoYSuXXieYSynthesis, characterization, and antitumor evaluation of the albumin-SN38 conjugateAnticancer Drugs201324327027723233044
   PubMed Web of Science ®Google Scholar
• VeltkampSAWitteveenEOCapriatiAClinical and pharmacologic study of the novel prodrug delimotecan (MEN 4901/T-0128) in patients with solid tumorsClin Cancer Res200814227535754419010872
   PubMedGoogle Scholar
• PatnaikAPapadopoulosKPTolcherAWPhase I dose-escalation study of EZN-2208 (PEG-SN38), a novel conjugate of poly(ethylene) glycol and SN38, administered weekly in patients with advanced cancerCancer Chemother Pharmacol20137161499150623543270
   PubMed Web of Science ®Google Scholar
• GuichardSTerretCHennebelleICPT-11 converting carboxylesterase and topoisomerase activities in tumour and normal colon and liver tissuesBr J Cancer1999803–436437010408839
   PubMedGoogle Scholar
• KhannaRMortonCLDanksMKPotterPMProficient metabolism of irinotecan by a human intestinal carboxylesteraseCancer Res200060174725472810987276
   PubMedGoogle Scholar
• AhmedFVyasVCornfieldAIn vitro activation of irinotecan to SN-38 by human liver and intestineAnticancer Res1999193A2067207110470149
   PubMedGoogle Scholar