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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Veröffentlicht in:Journal of clinical pharmacology Jg. 51; H. 8; S. 1205 - 1212
Hauptverfasser: 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
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Oxford, UK Blackwell Publishing Ltd 01.08.2011
SAGE Publications
Wiley Subscription Services, Inc
Schlagworte:
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
Online-Zugang:Volltext
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Zusammenfassung: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.
Bibliographie:ark:/67375/WNG-M6SK15GF-J
istex:9D0C3491846BFDB8F2BFEE1369D185C2A32BD1DE
ArticleID:JCPH5440
ObjectType-Article-1
SourceType-Scholarly Journals-1
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ISSN:0091-2700
1552-4604
1552-4604
DOI:10.1177/0091270010381499