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

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    Authors
    Sirohi, B
    Powles, R
    Chopra, Rajesh
    Russell, Nigel
    Byrne, J L
    Prentice, H Grant
    Potter, M
    Koblinger, S
    Affiliation
    Leukaemia and Myeloma Unit, Royal Marsden Hospital, Sutton, Surrey, UK.
    Issue Date
    2006-07
    
    Metadata
    Show full item record
    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.
    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
    URI
    http://hdl.handle.net/10541/72536
    DOI
    10.1038/sj.bmt.1705398
    PubMed ID
    16715107
    Type
    Article
    Language
    en
    ISSN
    0268-3369
    ae974a485f413a2113503eed53cd6c53
    10.1038/sj.bmt.1705398
    Scopus Count
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