Pharmacokinetics and Safety of Marqibo (Vincristine Sulfate Liposomes Injection) in Cancer Patients With Impaired Liver Function

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...

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Vydané v:	Journal of clinical pharmacology Ročník 51; číslo 8; s. 1205 - 1212
Hlavní autori:	Bedikian, Agop Y., Silverman, Jeffrey A., Papadopoulos, Nicholas E., Kim, Kevin B., Hagey, Anne E., Vardeleon, Anna, Hwu, Wen-Jen, Homsi, Jade, Davies, Michael, Hwu, Patrick
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Oxford, UK Blackwell Publishing Ltd 01.08.2011 SAGE Publications Wiley Subscription Services, Inc
Predmet:	Aged Antineoplastic Agents, Phytogenic - administration & dosage Antineoplastic Agents, Phytogenic - adverse effects Antineoplastic Agents, Phytogenic - blood Antineoplastic Agents, Phytogenic - pharmacokinetics Ascites - physiopathology Clinical pharmacology clinical research Female Half-Life Hepatic Insufficiency - etiology Humans Liposomes Liver cirrhosis Liver Neoplasms - drug therapy Liver Neoplasms - metabolism Liver Neoplasms - physiopathology Liver Neoplasms - secondary Male Melanoma - blood Melanoma - drug therapy Melanoma - metabolism Melanoma - secondary Metabolic Clearance Rate Middle Aged Neoplasm Staging oncology Pharmaceutical Vehicles - therapeutic use pharmacokinetics and drug metabolism pharmacology Skin Neoplasms - blood Skin Neoplasms - complications Skin Neoplasms - drug therapy Skin Neoplasms - metabolism Survival Analysis Tubulin Modulators - administration & dosage Tubulin Modulators - adverse effects Tubulin Modulators - blood Tubulin Modulators - pharmacokinetics Uveal Neoplasms - blood Uveal Neoplasms - complications Uveal Neoplasms - drug therapy Uveal Neoplasms - metabolism Vincristine - administration & dosage Vincristine - adverse effects Vincristine - blood Vincristine - pharmacokinetics
ISSN:	0091-2700, 1552-4604, 1552-4604
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Shrnutí:	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.
Bibliografia:	ark:/67375/WNG-M6SK15GF-J istex:9D0C3491846BFDB8F2BFEE1369D185C2A32BD1DE ArticleID:JCPH5440 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Feature-1 content type line 23
ISSN:	0091-2700 1552-4604 1552-4604
DOI:	10.1177/0091270010381499