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Pharmacokinetics and Safety of Marqibo (Vincristine Sulfate Liposomes Injection) in Cancer Patients With Impaired Liver Function
Author(s) -
Bedikian Agop Y.,
Silverman Jeffrey A.,
Papadopoulos Nicholas E.,
Kim Kevin B.,
Hagey Anne E.,
Vardeleon Anna,
Hwu WenJen,
Homsi Jade,
Davies Michael,
Hwu Patrick
Publication year - 2011
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270010381499
Subject(s) - pharmacokinetics , medicine , vincristine , liver function , pharmacology , liver function tests , liposome , disposition , liver cancer , impaired renal function , cancer , gastroenterology , renal function , chemotherapy , chemistry , biochemistry , psychology , social psychology , cyclophosphamide
Marqibo (vincristine sulfate liposome injection, VSLI) is a novel liposomal formulation of vincristine sulfate (VCR) being developed for the systemic treatment of cancer. This study evaluated the pharmacokinetics (PK) of Marqibo in subjects with melanoma and impaired hepatic function. Calculated PK parameters were similar in subjects with impaired liver function compared with those in subjects with adequate liver function. Subjects with impaired liver function universally had a monoexponential total plasma VCR concentration versus time decline, whereas two thirds of subjects with adequate liver function had a biexponential decline profile. Because one third of subjects with normal hepatic function demonstrated monoexponential disposition, lack of biexponential disposition in the hepatically impaired subjects cannot be clearly attributed to liver impairment. VSLI was generally well tolerated in all subjects.