{"refrec":{"BRefID":257564,"RR":"<b>Schoffski, P.; Dumez, H.; Ruijter, R.; Miguel-Lillo, B.; Soto-Matos, A.; Alfaro, V.; Giaccone, G.</b> (2011). Spisulosine (ES-285) given as a weekly three-hour intravenous infusion: results of a phase I dose-escalating study in patients with advanced solid malignancies. <i>Cancer Chemother. Pharmacol. 68(6)</i>: 1397-1403. <a href=\"http://dx.doi.org/10.1007/s00280-011-1612-1\" target=\"_blank\">dx.doi.org/10.1007/s00280-011-1612-1</a>","BEntID":249573,"PublicFlag":1,"CheckedFlag":1,"wosflag":1,"vabbflag":null,"RefStringPartII":". <i>Cancer Chemother. Pharmacol. 68(6)</i>: 1397-1403. <a href=\"https://dx.doi.org/10.1007/s00280-011-1612-1\" target=\"_blank\">https://dx.doi.org/10.1007/s00280-011-1612-1</a>","DocTypID":8,"DocType":"Journal article","MarineFlag":1,"FreshFlag":0,"BrackishFlag":0,"TerrestrialFlag":0,"Authorstring":"Schoffski, P.; Dumez, H.; Ruijter, R.; Miguel-Lillo, B.; Soto-Matos, A.; Alfaro, V.; Giaccone, G.","OrigTitleTranslFlag":0,"Authorstringtrunc":"Schoffski, P. <i>et al.</i>","Englishabstract":"Spisulosine is a marine compound that showed antitumor activity in preclinical studies. We report results of a phase I trial performed in patients with advanced solid tumors with the marine compound, with the aim to determine the maximum tolerated dose (MTD) of a weekly 3-h intravenous (iv.) infusion, and to evaluate the safety, efficacy, and pharmacokinetics (PK) of the compound. Two centers contributed 25 patients to the trial, and 7 dose levels were explored. In dose levels ranging from 4 to 128 mg/mA(2)/day, no dose-limiting toxicities (DLT) were observed. One patient had DLT at 200 mg/mA(2), a reversible grade 3 ALT increase. The MTD was not reached due to early termination of the Spisulosine trial program but is considered to be likely in the range of 200 mg/mA(2) for this schedule. Drug-related adverse reactions included mild to moderate nausea, pyrexia, injection site reactions, and vomiting. One case of grade 4 peripheral motor and sensory neuropathy associated with general weakness and pain was observed during treatment cycle 4 and possibly contributed to the death of the patient. Grade 3 laboratory abnormalities included anemia and lymphopenia and increases in liver enzymes (alkaline phosphatase, transaminases, and bilirubin). Objective responses were not observed, and only four patients had short-lasting stable disease (< 3 months). The PK data indicated a wide distribution, a long residence time, and dose proportionality of the agent. Hepato- and neuro-toxicity are schedule independent dose-limiting adverse events for this marine compound, as illustrated by this and other early clinical trials.","AbstractOtherLang":null,"BibLvlCode":"AS","StandardTitle":"Spisulosine (ES-285) given as a weekly three-hour intravenous infusion: results of a phase I dose-escalating study in patients with advanced solid malignancies","OrigTitleLangCode":"en","OrigTitleLangCodeExtended":"eng","OrigTitleLangID":15,"DateLastModified":{"date":"2024-12-10 01:33:17.368041","timezone_type":1,"timezone":"+01:00"},"UserAccessRight":null,"UserAccID":null,"AuthorKeywords":"ES-285; Spisulosine; Phase I; Marine compounds; Pharmacokinetics;Hepatotoxicity; Neurotoxicity","OtherDescriptors":null,"Notes":null,"AnaPub":2011,"MonPub":null,"DateUpdate":"2016-07-05","DateCreate":"2016-05-29","SecASFANote":null,"ConfID":null,"PeerRev":1,"VlizCoreFlag":1,"WoScode":"WOS:000297344300004","VABBcode":null,"OpenAcc":0,"DOI":"10.1007/s00280-011-1612-1"},"refs":null,"anarec":{"AnaID":257564,"PubliDate":2011,"Pagination":"1397-1403","XtraPublOfAnaID":null,"ISBN":null,"Volume":"68","Issue":"6","BRefMon":null,"BRefMonRR":null,"BRefXtra":null,"BRefXtraRR":null,"SerBRefID":259099,"SerRR":"Cancer Chemotherapy and Pharmacology. 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