A Phase I Clinical Trial of Spicamycin Derivative KRN5500 (NSC 650426) Using a Phase I Accelerated Titration “2B” Design
dc.contributor.author | Gadgeel, Shirish M. | en_US |
dc.contributor.author | Boinpally, Ramesh R. | en_US |
dc.contributor.author | Heilbrun, Lance K. | en_US |
dc.contributor.author | Wozniak, Antoinette | en_US |
dc.contributor.author | Jain, Vikash | en_US |
dc.contributor.author | Redman, Bruce G. | en_US |
dc.contributor.author | Zalupski, Mark M. | en_US |
dc.contributor.author | Wiegand, R. | en_US |
dc.contributor.author | Parchment, Ralph E. | en_US |
dc.contributor.author | LoRusso, Patricia M. | en_US |
dc.date.accessioned | 2006-09-11T15:49:39Z | |
dc.date.available | 2006-09-11T15:49:39Z | |
dc.date.issued | 2003-02 | en_US |
dc.identifier.citation | Gadgeel, S.M.; Boinpally, R.R.; Heilbrun, L.K.; Wozniak, A.; Jain, V.; Redman, B.; Zalupski, M.; Wiegand, R.; Parchment, R.; LoRusso, P.M.; (2003). "A Phase I Clinical Trial of Spicamycin Derivative KRN5500(NSC 650426) Using a Phase I Accelerated Titration “2B” Design." Investigational New Drugs 21 (1): 63-74. <http://hdl.handle.net/2027.42/45232> | en_US |
dc.identifier.issn | 0167-6997 | en_US |
dc.identifier.issn | 1573-0646 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/45232 | |
dc.identifier.uri | http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=12795531&dopt=citation | en_US |
dc.description.abstract | The spicamycin derivative KRN5500 was considered as a potential anti-cancer agent based on in vitro and preclinical studies. A Phase I study involving 24 cancer patients in whom tumors were refractory to all other conventional therapies was conducted to determine the dose limiting toxicity, maximum tolerated dose, effectiveness, and pharmacokinetic parameters of this drug administered by 1-h IV infusion daily for five consecutive days every 3 weeks. Using an accelerated dose titration strategy, 8.4 mg/m 2 /d × 5 days was the maximum administered dose. Severe gastrointestinal and hepatic toxicities were observed at doses at or above 4.3 mg/m 2 /d × 5. The recommended Phase II dose is 4.3 mg/m 2 /d × 5. The distribution of KRN5500 followed a two-compartment model, and clearance did not decrease significantly over the dose range 0.8–8.4 mg/m 2 /d × 5. No significant correlation was observed between plasma levels and toxicity. No tumor responses were observed among the 14 patients evaluable for response. | en_US |
dc.format.extent | 126233 bytes | |
dc.format.extent | 3115 bytes | |
dc.format.mimetype | application/pdf | |
dc.format.mimetype | text/plain | |
dc.language.iso | en_US | |
dc.publisher | Kluwer Academic Publishers; Springer Science+Business Media | en_US |
dc.subject.other | Medicine & Public Health | en_US |
dc.subject.other | Pharmacology/Toxicology | en_US |
dc.subject.other | Oncology | en_US |
dc.subject.other | Phase I Clinical Trial | en_US |
dc.subject.other | MTD | en_US |
dc.subject.other | Toxicity | en_US |
dc.subject.other | Clearance | en_US |
dc.subject.other | Pharmacokinetics | en_US |
dc.subject.other | Half-life | en_US |
dc.subject.other | Hepatotoxicity | en_US |
dc.title | A Phase I Clinical Trial of Spicamycin Derivative KRN5500 (NSC 650426) Using a Phase I Accelerated Titration “2B” Design | en_US |
dc.type | Article | en_US |
dc.subject.hlbsecondlevel | Chemistry | en_US |
dc.subject.hlbsecondlevel | Biological Chemistry | en_US |
dc.subject.hlbsecondlevel | Chemical Engineering | en_US |
dc.subject.hlbsecondlevel | Radiology | en_US |
dc.subject.hlbtoplevel | Science | en_US |
dc.subject.hlbtoplevel | Engineering | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.contributor.affiliationum | University of Michigan Cancer Center, Ann Arbor, MI, USA | en_US |
dc.contributor.affiliationum | University of Michigan Cancer Center, Ann Arbor, MI, USA | en_US |
dc.contributor.affiliationother | Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA | en_US |
dc.contributor.affiliationother | Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA | en_US |
dc.contributor.affiliationother | Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA | en_US |
dc.contributor.affiliationother | Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA | en_US |
dc.contributor.affiliationother | Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA | en_US |
dc.contributor.affiliationother | Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA | en_US |
dc.contributor.affiliationother | Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA | en_US |
dc.contributor.affiliationother | Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA | en_US |
dc.contributor.affiliationumcampus | Ann Arbor | en_US |
dc.identifier.pmid | 12795531 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/45232/1/10637_2004_Article_5109792.pdf | en_US |
dc.identifier.doi | http://dx.doi.org/10.1023/A:1022972427532 | en_US |
dc.identifier.source | Investigational New Drugs | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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