A study to determine the safety profile and maximum tolerated dose of micafungin (FK463) in patients undergoing haematopoietic stem cell transplantation.

2.50
Hdl Handle:
http://hdl.handle.net/10541/72536
Title:
A study to determine the safety profile and maximum tolerated dose of micafungin (FK463) in patients undergoing haematopoietic stem cell transplantation.
Authors:
Sirohi, B; Powles, R; Chopra, Rajesh; Russell, Nigel; Byrne, J L; Prentice, H Grant; Potter, M; Koblinger, S
Abstract:
This open-label, dose-escalation study assessed the maximum tolerated dose (MTD) of the new antifungal micafungin in patients undergoing haematopoietic stem cell transplantation (HSCT). Participants received 3, 4, 6 or 8 mg/kg/day micafungin intravenously from 7 days to a maximum of 28 days or until neutropaenia resolved. The MTD was defined as the highest dose not causing the same Grade 3 or 4 adverse event in three or more patients. All 36 participants received >/=8 days treatment for a median of 18 days (range: 8-28); 1 patient withdrew consent and a further 11 discontinued to receive another systemic antifungal agent for a suspected infection. No case of confirmed invasive fungal infection occurred. Adverse events were those expected for patients undergoing HSCT and showed no evidence of dose-related toxicity. Criteria for MTD were not met; no patient had a Grade 3 or 4 adverse event considered causally related to micafungin. Thus, the MTD of micafungin can be inferred to be 8 mg/kg/day or higher.
Affiliation:
Leukaemia and Myeloma Unit, Royal Marsden Hospital, Sutton, Surrey, UK.
Citation:
A study to determine the safety profile and maximum tolerated dose of micafungin (FK463) in patients undergoing haematopoietic stem cell transplantation. 2006, 38 (1):47-51 Bone Marrow Transplant.
Journal:
Bone Marrow Transplantation
Issue Date:
Jul-2006
URI:
http://hdl.handle.net/10541/72536
DOI:
10.1038/sj.bmt.1705398
PubMed ID:
16715107
Type:
Article
Language:
en
ISSN:
0268-3369
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorSirohi, B-
dc.contributor.authorPowles, R-
dc.contributor.authorChopra, Rajesh-
dc.contributor.authorRussell, Nigel-
dc.contributor.authorByrne, J L-
dc.contributor.authorPrentice, H Grant-
dc.contributor.authorPotter, M-
dc.contributor.authorKoblinger, S-
dc.date.accessioned2009-07-06T10:25:46Z-
dc.date.available2009-07-06T10:25:46Z-
dc.date.issued2006-07-
dc.identifier.citationA study to determine the safety profile and maximum tolerated dose of micafungin (FK463) in patients undergoing haematopoietic stem cell transplantation. 2006, 38 (1):47-51 Bone Marrow Transplant.en
dc.identifier.issn0268-3369-
dc.identifier.pmid16715107-
dc.identifier.doi10.1038/sj.bmt.1705398-
dc.identifier.urihttp://hdl.handle.net/10541/72536-
dc.description.abstractThis open-label, dose-escalation study assessed the maximum tolerated dose (MTD) of the new antifungal micafungin in patients undergoing haematopoietic stem cell transplantation (HSCT). Participants received 3, 4, 6 or 8 mg/kg/day micafungin intravenously from 7 days to a maximum of 28 days or until neutropaenia resolved. The MTD was defined as the highest dose not causing the same Grade 3 or 4 adverse event in three or more patients. All 36 participants received >/=8 days treatment for a median of 18 days (range: 8-28); 1 patient withdrew consent and a further 11 discontinued to receive another systemic antifungal agent for a suspected infection. No case of confirmed invasive fungal infection occurred. Adverse events were those expected for patients undergoing HSCT and showed no evidence of dose-related toxicity. Criteria for MTD were not met; no patient had a Grade 3 or 4 adverse event considered causally related to micafungin. Thus, the MTD of micafungin can be inferred to be 8 mg/kg/day or higher.en
dc.language.isoenen
dc.subject.meshAdult-
dc.subject.meshAntifungal Agents-
dc.subject.meshDrug Administration Schedule-
dc.subject.meshEchinocandins-
dc.subject.meshFemale-
dc.subject.meshHematopoietic Stem Cell Transplantation-
dc.subject.meshHumans-
dc.subject.meshInfusions, Intravenous-
dc.subject.meshLipopeptides-
dc.subject.meshLipoproteins-
dc.subject.meshMale-
dc.subject.meshMaximum Tolerated Dose-
dc.subject.meshMiddle Aged-
dc.subject.meshPeptides, Cyclic-
dc.subject.meshSafety-
dc.subject.meshTransplantation, Autologous-
dc.subject.meshTransplantation, Homologous-
dc.subject.meshTreatment Outcome-
dc.titleA study to determine the safety profile and maximum tolerated dose of micafungin (FK463) in patients undergoing haematopoietic stem cell transplantation.en
dc.typeArticleen
dc.contributor.departmentLeukaemia and Myeloma Unit, Royal Marsden Hospital, Sutton, Surrey, UK.en
dc.identifier.journalBone Marrow Transplantationen

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