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...
Uložené v:
| Vydané v: | Journal of clinical pharmacology Ročník 51; číslo 8; s. 1205 - 1212 |
|---|---|
| Hlavní autori: | , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
| Vydavateľské údaje: |
Oxford, UK
Blackwell Publishing Ltd
01.08.2011
SAGE Publications Wiley Subscription Services, Inc |
| Predmet: | |
| ISSN: | 0091-2700, 1552-4604, 1552-4604 |
| On-line prístup: | Získať plný text |
| Tagy: |
Pridať tag
Žiadne tagy, Buďte prvý, kto otaguje tento záznam!
|
| Abstract | 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. |
|---|---|
| AbstractList | 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. 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.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. |
| Author | Davies, Michael Papadopoulos, Nicholas E. Hwu, Wen-Jen Homsi, Jade Hwu, Patrick Bedikian, Agop Y. Silverman, Jeffrey A. Vardeleon, Anna Kim, Kevin B. Hagey, Anne E. |
| Author_xml | – sequence: 1 givenname: Agop Y. surname: Bedikian fullname: Bedikian, Agop Y. organization: Department of Melanoma Medical Oncology, the University of Texas M. D. Anderson Cancer Center, Houston, Texas – sequence: 2 givenname: Jeffrey A. surname: Silverman fullname: Silverman, Jeffrey A. email: jeffrey.silverman@hanabiosciences.com organization: Hana Biosciences Inc., South San Francisco, California – sequence: 3 givenname: Nicholas E. surname: Papadopoulos fullname: Papadopoulos, Nicholas E. organization: Department of Melanoma Medical Oncology, the University of Texas M. D. Anderson Cancer Center, Houston, Texas – sequence: 4 givenname: Kevin B. surname: Kim fullname: Kim, Kevin B. organization: Department of Melanoma Medical Oncology, the University of Texas M. D. Anderson Cancer Center, Houston, Texas – sequence: 5 givenname: Anne E. surname: Hagey fullname: Hagey, Anne E. organization: Hana Biosciences Inc., South San Francisco, California – sequence: 6 givenname: Anna surname: Vardeleon fullname: Vardeleon, Anna organization: Department of Melanoma Medical Oncology, the University of Texas M. D. Anderson Cancer Center, Houston, Texas – sequence: 7 givenname: Wen-Jen surname: Hwu fullname: Hwu, Wen-Jen organization: Department of Melanoma Medical Oncology, the University of Texas M. D. Anderson Cancer Center, Houston, Texas – sequence: 8 givenname: Jade surname: Homsi fullname: Homsi, Jade organization: Department of Melanoma Medical Oncology, the University of Texas M. D. Anderson Cancer Center, Houston, Texas – sequence: 9 givenname: Michael surname: Davies fullname: Davies, Michael organization: Department of Melanoma Medical Oncology, the University of Texas M. D. Anderson Cancer Center, Houston, Texas – sequence: 10 givenname: Patrick surname: Hwu fullname: Hwu, Patrick organization: Department of Melanoma Medical Oncology, the University of Texas M. D. Anderson Cancer Center, Houston, Texas |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/20978276$$D View this record in MEDLINE/PubMed |
| BookMark | eNqFks9v0zAUxyM0xLrBnROyxAE4BOzEP5IjqmjX0UGlAjtarvOiuk3tznYovfGn49IxpB7gZNnfz8d-es8X2Zl1FrLsOcFvCRHiHcY1KQTGBJcVoXX9KBsQxoqcckzPssEhzg_5eXYRwipxnDLyJDsvcC2qQvBB9nO2VH6jtFsbC9HogJRt0Fy1EPfItehG-TuzcOj1N2O1NyEmDM37rlUR0NRsXXAbCGhiV6CjcfYNMhYNldXg0UxFAzYGdGviEk02W2U8NMn6nsJRb38LT7PHreoCPLtfL7Ovow9fhlf59PN4Mnw_zTVlXORtU6qGE401YAYc2oYuWkYqrahoC1XTkhUciqpYqILyRjMNvCYNaxVoCrgtL7NXx3u33t31EKLcmKCh65QF1wdZiYrVHLM6kS9PyJXrvU3FSSIw56IoqzJRL-6pfrGBRm692Si_l39amwB8BLR3IXhoHxCC5WF68nR6SeEnijZRHboUvTLdv0R6FHeui-DDuut34OUSVBeXCceYJjwvMCG4Srv8cCT-vrczHez_W5-8Hs6uGKU4iflRTB8CfjyIyq8lF6Vg8vbTWN7w-UfCxiN5Xf4CWPvLXw |
| CitedBy_id | crossref_primary_10_1007_BF03262418 crossref_primary_10_1016_j_ejps_2012_07_002 crossref_primary_10_3389_fphar_2018_00991 crossref_primary_10_1038_aps_2012_44 crossref_primary_10_1016_j_jphotobiol_2022_112500 crossref_primary_10_1634_theoncologist_2015_0391 crossref_primary_10_3390_catal13020250 crossref_primary_10_1517_17425255_2014_885016 crossref_primary_10_2217_nnm_11_140 crossref_primary_10_3390_ijms20194706 crossref_primary_10_1016_j_xphs_2019_05_009 crossref_primary_10_1016_j_chroma_2012_12_026 crossref_primary_10_1080_03639045_2016_1275671 crossref_primary_10_1016_j_ijpharm_2020_119269 crossref_primary_10_3109_08982104_2014_950277 crossref_primary_10_3390_ijms21249559 crossref_primary_10_3389_fchem_2014_00069 crossref_primary_10_2217_nnm_2017_0430 crossref_primary_10_1016_j_jconrel_2025_113991 crossref_primary_10_1016_S1875_5364_24_60726_0 crossref_primary_10_1310_hpj4801_14 crossref_primary_10_1200_JCO_2012_46_2309 crossref_primary_10_1016_j_jphotobiol_2021_112146 crossref_primary_10_1007_s00204_022_03418_8 crossref_primary_10_3390_cancers17071186 crossref_primary_10_3390_cancers14194652 |
| Cites_doi | 10.1097/CMR.0b013e328311aaa1 10.1023/A:1020134521778 10.1007/s00280-005-0145-x 10.1016/S0009-9236(96)90021-1 10.1634/theoncologist.2007-0180 10.1002/cncr.24359 10.1002/cpt1977224430 10.1177/0091270006288953 10.1016/S0031-6997(24)01426-1 10.1200/JCO.1999.17.2.697 10.1007/BF00255487 10.1002/cncr.21595 10.2174/187152006778699095 10.1002/cncr.24632 10.1097/00001813-199508000-00001 10.1016/S0022-3565(24)29494-5 10.1016/S0959-8049(97)00340-7 |
| ContentType | Journal Article |
| Copyright | 2011 American College of Clinical Pharmacology 2011 SAGE Publications |
| Copyright_xml | – notice: 2011 American College of Clinical Pharmacology – notice: 2011 SAGE Publications |
| DBID | BSCLL AAYXX CITATION CGR CUY CVF ECM EIF NPM 7QP 7QR 7T5 7TK 7TM 8FD FR3 H94 K9. NAPCQ P64 RC3 7X8 |
| DOI | 10.1177/0091270010381499 |
| DatabaseName | Istex CrossRef Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed Calcium & Calcified Tissue Abstracts Chemoreception Abstracts Immunology Abstracts Neurosciences Abstracts Nucleic Acids Abstracts Technology Research Database Engineering Research Database AIDS and Cancer Research Abstracts ProQuest Health & Medical Complete (Alumni) Nursing & Allied Health Premium Biotechnology and BioEngineering Abstracts Genetics Abstracts MEDLINE - Academic |
| DatabaseTitle | CrossRef MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) Nursing & Allied Health Premium Genetics Abstracts Technology Research Database Nucleic Acids Abstracts AIDS and Cancer Research Abstracts ProQuest Health & Medical Complete (Alumni) Chemoreception Abstracts Immunology Abstracts Engineering Research Database Calcium & Calcified Tissue Abstracts Neurosciences Abstracts Biotechnology and BioEngineering Abstracts MEDLINE - Academic |
| DatabaseTitleList | MEDLINE MEDLINE - Academic Nursing & Allied Health Premium |
| Database_xml | – sequence: 1 dbid: NPM name: PubMed url: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed sourceTypes: Index Database – sequence: 2 dbid: 7X8 name: MEDLINE - Academic url: https://search.proquest.com/medline sourceTypes: Aggregation Database |
| DeliveryMethod | fulltext_linktorsrc |
| Discipline | Pharmacy, Therapeutics, & Pharmacology |
| EISSN | 1552-4604 |
| EndPage | 1212 |
| ExternalDocumentID | 3787302991 20978276 10_1177_0091270010381499 00004700-201108000-00007 JCPH5440 ark_67375_WNG_M6SK15GF_J |
| Genre | miscellaneous Clinical Trial Research Support, Non-U.S. Gov't Journal Article |
| GroupedDBID | --- .55 .GJ 05W 0R~ 123 18M 1CY 1OB 1OC 29K 33P 34G 39C 3O- 3SF 4.4 52U 52V 53G 5RE 8-1 AAESR AAEVG AAHQN AAIPD AAMMB AAMNL AANHP AANLZ AAONW AASGY AAWTL AAXRX AAYCA AAZKR ABCUV ABJNI ABQWH ABXGK ACAHQ ACBWZ ACCZN ACGFO ACGFS ACGOF ACIWK ACMXC ACPOU ACPRK ACRPL ACXBN ACXQS ACYXJ ADBBV ADBTR ADEOM ADIZJ ADMGS ADNMO ADOZA ADSTG ADXAS AEFGJ AEGXH AEIGN AEIMD AENEX AEUYR AEYWJ AFBPY AFFNX AFFPM AFGKR AFRAH AFWVQ AGHNM AGQPQ AGXDD AGYGG AHBTC AHMBA AI. AIACR AIAGR AIDQK AIDYY AIQQE AITYG AIURR ALMA_UNASSIGNED_HOLDINGS ALUQN ALVPJ AMBMR AMYDB ASPBG ATUGU AUVAJ AVWKF AZFZN AZVAB BDRZF BFHJK BHBCM BMXJE BOGZA BRXPI BSCLL C45 CAG COF CS3 D-I DCZOG DPXWK DRFUL DRMAN DRSTM DU5 EBD EBS EJD EMOBN F5P FEDTE FUBAC G-S GODZA GWYGA H13 HF~ HGLYW HVGLF IAO IEA IHR INH INR IVC KBYEO LATKE LEEKS LH4 LOXES LSO LUTES LW6 LYRES MEWTI MRFUL MRMAN MRSTM MSFUL MSMAN MSSTM MXFUL MXMAN MXSTM MY~ N9A O66 O9- OVD P2P P2W PALCI PQQKQ R.K RIWAO RJQFR ROL SAMSI SUPJJ SV3 TEORI VH1 WBKPD WH7 WIH WIJ WIK WOHZO WOIKV WPGGZ WXSBR X7M ZGI ZXP ZZTAW AAHHS AAYOK ACCFJ AEEZP AEQDE AIWBW AJBDE M4V AAYXX CITATION A00 ACXME AFPWT CGR CUY CVF ECM EIF NPM WYJ YCJ 7QP 7QR 7T5 7TK 7TM 8FD FR3 H94 K9. NAPCQ P64 RC3 7X8 |
| ID | FETCH-LOGICAL-c4567-fd3ad61c0ce05e6efd4bf518ca47f2a943526e282ba246dc5ce691d5faec4e0f3 |
| IEDL.DBID | DRFUL |
| ISICitedReferencesCount | 33 |
| ISICitedReferencesURI | http://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=Summon&SrcAuth=ProQuest&DestLinkType=CitingArticles&DestApp=WOS_CPL&KeyUT=00004700-201108000-00007&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| ISSN | 0091-2700 1552-4604 |
| IngestDate | Wed Oct 01 10:24:03 EDT 2025 Mon Oct 06 17:52:12 EDT 2025 Wed Feb 19 01:47:54 EST 2025 Tue Nov 18 21:49:39 EST 2025 Sat Nov 29 08:14:25 EST 2025 Fri May 16 04:03:38 EDT 2025 Wed Sep 03 09:00:53 EDT 2025 Sun Sep 21 06:18:38 EDT 2025 |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 8 |
| Language | English |
| License | http://doi.wiley.com/10.1002/tdm_license_1 |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c4567-fd3ad61c0ce05e6efd4bf518ca47f2a943526e282ba246dc5ce691d5faec4e0f3 |
| Notes | 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 |
| PMID | 20978276 |
| PQID | 1706672383 |
| PQPubID | 37812 |
| PageCount | 8 |
| ParticipantIDs | proquest_miscellaneous_878596059 proquest_journals_1706672383 pubmed_primary_20978276 crossref_primary_10_1177_0091270010381499 crossref_citationtrail_10_1177_0091270010381499 wolterskluwer_health_00004700-201108000-00007 wiley_primary_10_1177_0091270010381499_JCPH5440 istex_primary_ark_67375_WNG_M6SK15GF_J |
| PublicationCentury | 2000 |
| PublicationDate | 2011-08 August 2011 2011-August 2011-08-00 2011-Aug 20110801 |
| PublicationDateYYYYMMDD | 2011-08-01 |
| PublicationDate_xml | – month: 08 year: 2011 text: 2011-08 |
| PublicationDecade | 2010 |
| PublicationPlace | Oxford, UK |
| PublicationPlace_xml | – name: Oxford, UK – name: England – name: Rockville |
| PublicationTitle | Journal of clinical pharmacology |
| PublicationTitleAlternate | J Clin Pharmacol |
| PublicationYear | 2011 |
| Publisher | Blackwell Publishing Ltd SAGE Publications Wiley Subscription Services, Inc |
| Publisher_xml | – name: Blackwell Publishing Ltd – name: SAGE Publications – name: Wiley Subscription Services, Inc |
| References | Ishida T, Harashima H, Kiwada H. Liposome clearance. Biosci Rep. 2002; 22: 197-224. Donelli MG, Zucchetti M, Munzone E, D'Incalci M, Crosignani A. Pharmacokinetics of anticancer agents in patients with impaired liver function. Eur J Cancer. 1998; 34: 33-46. Bender RA, Castle MC, Margileth DA, Oliverio VT. The pharmacokinetics of [3H]-vincristine in man. Clin Pharmacol Ther. 1977; 22: 430-435. Minko T, Pakunlu RI, Wang Y, Khandare JJ, Saad M. New generation of liposomal drugs for cancer. Anticancer Agents Med Chem. 2006; 6: 537-552. Rodriguez MA, Pytlik R, Kozak T, et al. Vincristine sulfate liposomes injection (Marqibo) in heavily pretreated patients with refractory aggressive non-Hodgkin lymphoma: report of the pivotal phase 2 study. Cancer. 2009; 115: 3475-3482. Abbott KL, Harman GS. Combination chemotherapy for disseminated malignant melanoma. Anticancer Drugs. 1995; 6: 489-497. Shan S, Flowers C, Peltz CD, et al. Preferential extravasation and accumulation of liposomal vincristine in tumor comparing to normal tissue enhances antitumor activity. Cancer Chemother Pharmacol. 2006; 58: 245-255. DeVita VT, Hellman S, Rosenberg SA, eds. Cancer: Principles & Practice of oncology. 5th ed. Philadelphia, Pa: Lippincott-Raven; 1997. Zamboni WC. Concept and clinical evaluation of carrier-mediated anticancer agents. oncologist. 2008; 13: 248-260. Bedikian AY, Papadopoulos NE, Kim KB, et al. A pilot study with vincristine sulfate liposome infusion in patients with metastatic melanoma. Melanoma Res. 2008; 18: 400-404. Thomas DA, Sarris AH, Cortes J, et al. Phase II study of sphin-gosomal vincristine in patients with recurrent or refractory adult acute lymphocytic leukemia. Cancer. 2006; 106: 120-127. Krishna R, Webb MS, St Onge G, Mayer LD. Liposomal and nonliposomal drug pharmacokinetics after administration of liposome-encapsulated vincristine and their contribution to drug tissue distribution properties. J Pharmacol Exp Ther. 2001; 298: 1206-1212. Van den Berg HW, Desai ZR, Wilson R, Kennedy G, Bridges JM, Shanks RG. The pharmacokinetics of vincristine in man: reduced drug clearance associated with raised serum alkaline phosphatase and dose-limited elimination. Cancer Chemother Pharmacol. 1982; 8: 215-219. Gelmon KA, Tolcher A, Diab AR, et al. Phase I study of liposomal vincristine. J Clin Oncol. 1999; 17: 697-705. Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic function: Study Design, Data Analysis, and Impact on Dosing and Labeling. Rockville, Md: US Food and Drug Administration; 2003. Thomas DA, Kantarjian HM, Stock W, et al. Phase 1 multicenter study of vincristine sulfate liposomes injection and dexamethasone in adults with relapsed or refractory acute lymphoblastic leukemia. Cancer. 2009; 115: 5490-5498. Dorr R, von Hoff D, eds. Cancer Chemotherapy Handbook. 2nd ed. Norwalk, Conn: Appleton & Lange; 1994. Drummond DC, Meyer O, Hong K, Kirpotin DB, Papahadjopoulos D. Optimizing liposomes for delivery of chemotherapeutic agents to solid tumors. Pharmacol Rev. 1999; 51: 691-744. Bedikian AY, Vardeleon A, Smith T, Campbell S, Namdari R. Pharmacokinetics and urinary excretion of vincristine sulfate liposomes injection in metastatic melanoma patients. J Clin Pharmacol. 2006; 46: 727-737. Handbook for Reporting Results of Cancer Treatment. Geneva, Switzerland: World Health Organization; 1979. Kufe DB, William RC, Hong NH, et al. Cancer Medicine. 7th ed. Hamilton, Ontario: BC Decker; 2006. Robieux I, Sorio R, Borsatti E, et al. Pharmacokinetics of vinorelbine in patients with liver metastases. Clin Pharmacol Ther. 1996; 59: 32-40. 2001; 298 2001 2006; 46 1999; 17 2008; 18 2006; 58 2002; 22 1997 1996 2006 2008; 13 2006; 6 1982; 8 1994 1977; 22 1999; 51 2003 1996; 59 2006; 106 1998; 34 1995; 6 1968 1979 2009; 115 Krishna (10.1177/0091270010381499-BIB13|cit13) 2001; 298 Ishida (10.1177/0091270010381499-BIB21|cit21) 2002; 22 Rowinsky (10.1177/0091270010381499-BIB4|cit4) 1996 Minko (10.1177/0091270010381499-BIB10|cit10) 2006; 6 Drummond (10.1177/0091270010381499-BIB11|cit11) 1999; 51 (10.1177/0091270010381499-BIB16|cit16) 2003 Thomas (10.1177/0091270010381499-BIB24|cit24) 2009; 115 Lotze (10.1177/0091270010381499-BIB19|cit19) 2001 Rodriguez (10.1177/0091270010381499-BIB23|cit23) 2009; 115 Kufe (10.1177/0091270010381499-BIB2|cit2) 2006 (10.1177/0091270010381499-BIB1|cit1) 1994 Bedikian (10.1177/0091270010381499-BIB20|cit20) 2008; 18 Thomas (10.1177/0091270010381499-BIB25|cit25) 2006; 106 Shan (10.1177/0091270010381499-BIB22|cit22) 2006; 58 Robieux (10.1177/0091270010381499-BIB8|cit8) 1996; 59 Gelmon (10.1177/0091270010381499-BIB12|cit12) 1999; 17 (10.1177/0091270010381499-BIB14|cit14) 1979 Donelli (10.1177/0091270010381499-BIB7|cit7) 1998; 34 Zamboni (10.1177/0091270010381499-BIB9|cit9) 2008; 13 Bedikian (10.1177/0091270010381499-BIB15|cit15) 2006; 46 (10.1177/0091270010381499-BIB5|cit5) 1997 Berg (10.1177/0091270010381499-BIB17|cit17) 1982; 8 Noble (10.1177/0091270010381499-BIB3|cit3) 1968 Bender (10.1177/0091270010381499-BIB6|cit6) 1977; 22 Abbott (10.1177/0091270010381499-BIB18|cit18) 1995; 6 |
| References_xml | – reference: Bedikian AY, Vardeleon A, Smith T, Campbell S, Namdari R. Pharmacokinetics and urinary excretion of vincristine sulfate liposomes injection in metastatic melanoma patients. J Clin Pharmacol. 2006; 46: 727-737. – reference: Abbott KL, Harman GS. Combination chemotherapy for disseminated malignant melanoma. Anticancer Drugs. 1995; 6: 489-497. – reference: Rodriguez MA, Pytlik R, Kozak T, et al. Vincristine sulfate liposomes injection (Marqibo) in heavily pretreated patients with refractory aggressive non-Hodgkin lymphoma: report of the pivotal phase 2 study. Cancer. 2009; 115: 3475-3482. – reference: Dorr R, von Hoff D, eds. Cancer Chemotherapy Handbook. 2nd ed. Norwalk, Conn: Appleton & Lange; 1994. – reference: Bedikian AY, Papadopoulos NE, Kim KB, et al. A pilot study with vincristine sulfate liposome infusion in patients with metastatic melanoma. Melanoma Res. 2008; 18: 400-404. – reference: Van den Berg HW, Desai ZR, Wilson R, Kennedy G, Bridges JM, Shanks RG. The pharmacokinetics of vincristine in man: reduced drug clearance associated with raised serum alkaline phosphatase and dose-limited elimination. Cancer Chemother Pharmacol. 1982; 8: 215-219. – reference: Thomas DA, Sarris AH, Cortes J, et al. Phase II study of sphin-gosomal vincristine in patients with recurrent or refractory adult acute lymphocytic leukemia. Cancer. 2006; 106: 120-127. – reference: Handbook for Reporting Results of Cancer Treatment. Geneva, Switzerland: World Health Organization; 1979. – reference: Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic function: Study Design, Data Analysis, and Impact on Dosing and Labeling. Rockville, Md: US Food and Drug Administration; 2003. – reference: Krishna R, Webb MS, St Onge G, Mayer LD. Liposomal and nonliposomal drug pharmacokinetics after administration of liposome-encapsulated vincristine and their contribution to drug tissue distribution properties. J Pharmacol Exp Ther. 2001; 298: 1206-1212. – reference: Zamboni WC. Concept and clinical evaluation of carrier-mediated anticancer agents. oncologist. 2008; 13: 248-260. – reference: DeVita VT, Hellman S, Rosenberg SA, eds. Cancer: Principles & Practice of oncology. 5th ed. Philadelphia, Pa: Lippincott-Raven; 1997. – reference: Bender RA, Castle MC, Margileth DA, Oliverio VT. The pharmacokinetics of [3H]-vincristine in man. Clin Pharmacol Ther. 1977; 22: 430-435. – reference: Ishida T, Harashima H, Kiwada H. Liposome clearance. Biosci Rep. 2002; 22: 197-224. – reference: Kufe DB, William RC, Hong NH, et al. Cancer Medicine. 7th ed. Hamilton, Ontario: BC Decker; 2006. – reference: Robieux I, Sorio R, Borsatti E, et al. Pharmacokinetics of vinorelbine in patients with liver metastases. Clin Pharmacol Ther. 1996; 59: 32-40. – reference: Gelmon KA, Tolcher A, Diab AR, et al. Phase I study of liposomal vincristine. J Clin Oncol. 1999; 17: 697-705. – reference: Drummond DC, Meyer O, Hong K, Kirpotin DB, Papahadjopoulos D. Optimizing liposomes for delivery of chemotherapeutic agents to solid tumors. Pharmacol Rev. 1999; 51: 691-744. – reference: Minko T, Pakunlu RI, Wang Y, Khandare JJ, Saad M. New generation of liposomal drugs for cancer. Anticancer Agents Med Chem. 2006; 6: 537-552. – reference: Shan S, Flowers C, Peltz CD, et al. Preferential extravasation and accumulation of liposomal vincristine in tumor comparing to normal tissue enhances antitumor activity. Cancer Chemother Pharmacol. 2006; 58: 245-255. – reference: Donelli MG, Zucchetti M, Munzone E, D'Incalci M, Crosignani A. Pharmacokinetics of anticancer agents in patients with impaired liver function. Eur J Cancer. 1998; 34: 33-46. – reference: Thomas DA, Kantarjian HM, Stock W, et al. Phase 1 multicenter study of vincristine sulfate liposomes injection and dexamethasone in adults with relapsed or refractory acute lymphoblastic leukemia. Cancer. 2009; 115: 5490-5498. – volume: 22 start-page: 197 year: 2002 end-page: 224 article-title: Liposome clearance publication-title: Biosci Rep – volume: 115 start-page: 3475 year: 2009 end-page: 3482 article-title: Vincristine sulfate liposomes injection (Marqibo) in heavily pretreated patients with refractory aggressive non‐Hodgkin lymphoma: report of the pivotal phase 2 study publication-title: Cancer – volume: 106 start-page: 120 year: 2006 end-page: 127 article-title: Phase II study of sphin‐gosomal vincristine in patients with recurrent or refractory adult acute lymphocytic leukemia publication-title: Cancer – volume: 46 start-page: 727 year: 2006 end-page: 737 article-title: Pharmacokinetics and urinary excretion of vincristine sulfate liposomes injection in metastatic melanoma patients publication-title: J Clin Pharmacol – volume: 51 start-page: 691 year: 1999 end-page: 744 article-title: Optimizing liposomes for delivery of chemotherapeutic agents to solid tumors publication-title: Pharmacol Rev – volume: 8 start-page: 215 year: 1982 end-page: 219 article-title: The pharmacokinetics of vincristine in man: reduced drug clearance associated with raised serum alkaline phosphatase and dose‐limited elimination publication-title: Cancer Chemother Pharmacol – volume: 58 start-page: 245 year: 2006 end-page: 255 article-title: Preferential extravasation and accumulation of liposomal vincristine in tumor comparing to normal tissue enhances antitumor activity publication-title: Cancer Chemother Pharmacol – year: 1968 – volume: 13 start-page: 248 year: 2008 end-page: 260 article-title: Concept and clinical evaluation of carrier‐mediated anticancer agents publication-title: oncologist – year: 2001 – year: 2003 – volume: 115 start-page: 5490 year: 2009 end-page: 5498 article-title: Phase 1 multicenter study of vincristine sulfate liposomes injection and dexamethasone in adults with relapsed or refractory acute lymphoblastic leukemia publication-title: Cancer – volume: 22 start-page: 430 year: 1977 end-page: 435 article-title: The pharmacokinetics of [3H]‐vincristine in man publication-title: Clin Pharmacol Ther – volume: 6 start-page: 489 year: 1995 end-page: 497 article-title: Combination chemotherapy for disseminated malignant melanoma publication-title: Anticancer Drugs – volume: 18 start-page: 400 year: 2008 end-page: 404 article-title: A pilot study with vincristine sulfate liposome infusion in patients with metastatic melanoma publication-title: Melanoma Res – year: 1979 – year: 1994 – volume: 17 start-page: 697 year: 1999 end-page: 705 article-title: Phase I study of liposomal vincristine publication-title: J Clin Oncol – year: 2006 – start-page: 263 year: 1996 end-page: 296 – volume: 59 start-page: 32 year: 1996 end-page: 40 article-title: Pharmacokinetics of vinorelbine in patients with liver metastases publication-title: Clin Pharmacol Ther – year: 1997 – volume: 6 start-page: 537 year: 2006 end-page: 552 article-title: New generation of liposomal drugs for cancer publication-title: Anticancer Agents Med Chem – volume: 34 start-page: 33 year: 1998 end-page: 46 article-title: Pharmacokinetics of anticancer agents in patients with impaired liver function publication-title: Eur J Cancer – volume: 298 start-page: 1206 year: 2001 end-page: 1212 article-title: Liposomal and nonliposomal drug pharmacokinetics after administration of liposome‐encapsulated vincristine and their contribution to drug tissue distribution properties publication-title: J Pharmacol Exp Ther – volume: 18 start-page: 400 year: 2008 ident: 10.1177/0091270010381499-BIB20|cit20 article-title: A pilot study with vincristine sulfate liposome infusion in patients with metastatic melanoma publication-title: Melanoma Res doi: 10.1097/CMR.0b013e328311aaa1 – volume: 22 start-page: 197 year: 2002 ident: 10.1177/0091270010381499-BIB21|cit21 article-title: Liposome clearance publication-title: Biosci Rep doi: 10.1023/A:1020134521778 – volume: 58 start-page: 245 year: 2006 ident: 10.1177/0091270010381499-BIB22|cit22 article-title: Preferential extravasation and accumulation of liposomal vincristine in tumor comparing to normal tissue enhances antitumor activity publication-title: Cancer Chemother Pharmacol doi: 10.1007/s00280-005-0145-x – volume-title: Handbook for Reporting Results of Cancer Treatment year: 1979 ident: 10.1177/0091270010381499-BIB14|cit14 – volume: 59 start-page: 32 year: 1996 ident: 10.1177/0091270010381499-BIB8|cit8 article-title: Pharmacokinetics of vinorelbine in patients with liver metastases publication-title: Clin Pharmacol Ther doi: 10.1016/S0009-9236(96)90021-1 – volume: 13 start-page: 248 year: 2008 ident: 10.1177/0091270010381499-BIB9|cit9 article-title: Concept and clinical evaluation of carrier-mediated anticancer agents publication-title: oncologist doi: 10.1634/theoncologist.2007-0180 – volume: 115 start-page: 3475 year: 2009 ident: 10.1177/0091270010381499-BIB23|cit23 article-title: Vincristine sulfate liposomes injection (Marqibo) in heavily pretreated patients with refractory aggressive non-Hodgkin lymphoma: report of the pivotal phase 2 study publication-title: Cancer doi: 10.1002/cncr.24359 – volume: 22 start-page: 430 year: 1977 ident: 10.1177/0091270010381499-BIB6|cit6 article-title: The pharmacokinetics of [3H]-vincristine in man publication-title: Clin Pharmacol Ther doi: 10.1002/cpt1977224430 – volume: 46 start-page: 727 year: 2006 ident: 10.1177/0091270010381499-BIB15|cit15 article-title: Pharmacokinetics and urinary excretion of vincristine sulfate liposomes injection in metastatic melanoma patients publication-title: J Clin Pharmacol doi: 10.1177/0091270006288953 – volume-title: The Vinca Alkaloids in the Chemotherapy of Malignant Disease year: 1968 ident: 10.1177/0091270010381499-BIB3|cit3 – volume: 51 start-page: 691 year: 1999 ident: 10.1177/0091270010381499-BIB11|cit11 article-title: Optimizing liposomes for delivery of chemotherapeutic agents to solid tumors publication-title: Pharmacol Rev doi: 10.1016/S0031-6997(24)01426-1 – volume: 17 start-page: 697 year: 1999 ident: 10.1177/0091270010381499-BIB12|cit12 article-title: Phase I study of liposomal vincristine publication-title: J Clin Oncol doi: 10.1200/JCO.1999.17.2.697 – volume-title: Cancer: Principles & Practice of oncology year: 1997 ident: 10.1177/0091270010381499-BIB5|cit5 – volume: 8 start-page: 215 year: 1982 ident: 10.1177/0091270010381499-BIB17|cit17 article-title: The pharmacokinetics of vincristine in man: reduced drug clearance associated with raised serum alkaline phosphatase and dose-limited elimination publication-title: Cancer Chemother Pharmacol doi: 10.1007/BF00255487 – volume: 106 start-page: 120 year: 2006 ident: 10.1177/0091270010381499-BIB25|cit25 article-title: Phase II study of sphin-gosomal vincristine in patients with recurrent or refractory adult acute lymphocytic leukemia publication-title: Cancer doi: 10.1002/cncr.21595 – volume: 6 start-page: 537 year: 2006 ident: 10.1177/0091270010381499-BIB10|cit10 article-title: New generation of liposomal drugs for cancer publication-title: Anticancer Agents Med Chem doi: 10.2174/187152006778699095 – volume-title: Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic function: Study Design, Data Analysis, and Impact on Dosing and Labeling year: 2003 ident: 10.1177/0091270010381499-BIB16|cit16 – volume-title: Cancer Medicine year: 2006 ident: 10.1177/0091270010381499-BIB2|cit2 – volume: 115 start-page: 5490 year: 2009 ident: 10.1177/0091270010381499-BIB24|cit24 article-title: Phase 1 multicenter study of vincristine sulfate liposomes injection and dexamethasone in adults with relapsed or refractory acute lymphoblastic leukemia publication-title: Cancer doi: 10.1002/cncr.24632 – volume: 6 start-page: 489 year: 1995 ident: 10.1177/0091270010381499-BIB18|cit18 article-title: Combination chemotherapy for disseminated malignant melanoma publication-title: Anticancer Drugs doi: 10.1097/00001813-199508000-00001 – start-page: 263 volume-title: Cancer Chemotherapy and Biotherapy: Principles and Practice year: 1996 ident: 10.1177/0091270010381499-BIB4|cit4 – volume-title: Cancer, Principles & Practice of oncology year: 2001 ident: 10.1177/0091270010381499-BIB19|cit19 – volume: 298 start-page: 1206 year: 2001 ident: 10.1177/0091270010381499-BIB13|cit13 article-title: Liposomal and nonliposomal drug pharmacokinetics after administration of liposome-encapsulated vincristine and their contribution to drug tissue distribution properties publication-title: J Pharmacol Exp Ther doi: 10.1016/S0022-3565(24)29494-5 – volume-title: Cancer Chemotherapy Handbook year: 1994 ident: 10.1177/0091270010381499-BIB1|cit1 – volume: 34 start-page: 33 year: 1998 ident: 10.1177/0091270010381499-BIB7|cit7 article-title: Pharmacokinetics of anticancer agents in patients with impaired liver function publication-title: Eur J Cancer doi: 10.1016/S0959-8049(97)00340-7 |
| SSID | ssj0016451 |
| Score | 2.14703 |
| Snippet | Marqibo (vincristine sulfate liposome injection, VSLI) is a novel liposomal formulation of vincristine sulfate (VCR) being developed for the systemic treatment... |
| SourceID | proquest pubmed crossref wolterskluwer wiley istex |
| SourceType | Aggregation Database Index Database Enrichment Source Publisher |
| StartPage | 1205 |
| SubjectTerms | 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 |
| Title | Pharmacokinetics and Safety of Marqibo (Vincristine Sulfate Liposomes Injection) in Cancer Patients With Impaired Liver Function |
| URI | https://api.istex.fr/ark:/67375/WNG-M6SK15GF-J/fulltext.pdf https://onlinelibrary.wiley.com/doi/abs/10.1177%2F0091270010381499 https://ovidsp.ovid.com/ovidweb.cgi?T=JS&NEWS=n&CSC=Y&PAGE=fulltext&D=ovft&AN=00004700-201108000-00007 https://www.ncbi.nlm.nih.gov/pubmed/20978276 https://www.proquest.com/docview/1706672383 https://www.proquest.com/docview/878596059 |
| Volume | 51 |
| WOSCitedRecordID | wos00004700-201108000-00007&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| hasFullText | 1 |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| journalDatabaseRights | – providerCode: PRVWIB databaseName: Wiley Online Library - Journals customDbUrl: eissn: 1552-4604 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0016451 issn: 0091-2700 databaseCode: DRFUL dateStart: 19970101 isFulltext: true titleUrlDefault: https://onlinelibrary.wiley.com providerName: Wiley-Blackwell |
| link | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwrV3db9MwELfYygMI8c0IjMkPqGLSojmJHTuPqNB9sFUV3VjfLMexRdaRjKQF-safjp2vbhMCIfEYxWfHzt35zuf7HQCvUcS0T_zYxVpFLo5R5LI4FK6WwtfCmNiIJFWxCToasek0upoLU-NDdAduVjIqfW0FXMRNFZIqzGiMgzpqamNdptM10LO5VcYB6737ODw96mIJISZ13bzIs9lXaBWs3L3Zx7XNqWfX-cfvLM_WkL0L7n3PbVC7nFV32q_sTMMH_2NOD8H9xi6Fb2tGegRuqewx6I9rYOvlDjxZ5WmVO7APxyvI6-UT8LN9nJlPsE2gyBI4EVrNlzDX8FgUX9M4h28-pZms1Eqm4GRxoY2lC4_Sy7zMv6gSHmTn1c2wbBumGRxYhizguEZ-LeFZOv8MD4z6Mlo6MVRGCOHQbMuW4Ck4Hb4_Gey7TW0HVxqTjbo6CUQSehJJhYgKlU5wrInHpMBU-yLCFrdfGX8wFj4OE0mkCiMvIVooiRXSwTOwnuWZeg6gSqjAgS-FFKYTL4yMT-gFMQtUjClKmAN225_KZQN8butvXHCvxTq_sewO2O4oLmvQjz-07Vd80jUUxcxelqOEn432-HE4-eCRvSE_dMBmy0i80RMlt-BFoa37FjgAdq-NhNuwjchUvig5o4wYP5OYoTZq_uvG8m0Wjk9DM8WKrf76tfxwMN4nGCMHuNdYl9dpt7zyGQ2BWxmGrMEdQPTFP4_wEtxpz9-RtwnW58VCvQK35bd5WhZbYI1O2VYjqr8AJ8U3rg |
| linkProvider | Wiley-Blackwell |
| linkToHtml | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwrV3db9MwELdGiwQI8f1RGOAHVDFpUZ3EdpJHVOjara0q2n28WY5ji9CRjKQF-safjp2vsgmBkHiM4rNj5-585_P9DoDXKPCVQ5zQwkoGFg5RYPkh5ZYS3FFcm9iIREWxCW869c_OgtkO6Ne5MCU-RHPgZiSj0NdGwM2BdG8bZ9TWQRk2NcEu3es10MbU9fwWaL_7MDgeN8EEiklZOC-wTfoV2kYre1f7uLQ7tc1Cf_-d6VlbsrfA7W-piWrny-JS-y9b0-Duf5nUPXCnskzh25KV7oMdmTwA3VkJbb3Zh4ttpla-D7twtgW93jwEP-rHpf4G0wTyJIJzruRqA1MFJzz7EocpfHMSJ6JQLImE8_W50rYuHMcXaZ5-ljkcJZ-Ku2HJHowT2DcsmcFZif2aw9N49RGOtALTejrSVFoM4UBvzIbgETgevF_0h1ZV3cES2mjzLBW5PKK2QEIiIqlUEQ4VsX3BsaccHmCD3C-1RxhyB9NIECFpYEdEcSmwRMp9DFpJmsinAMrI49h1BBdcd2LTQHuFthv6rgyxhyK_A3r1X2Wigj43FTjOmV2jnV9Z9g7YayguStiPP7TtFozSNOTZ0lyX8wg7nR6wCZ0f2eRgwA47YLfmJFZpipwZ-CJqKr-5HQCb11rGTeCGJzJd58z3fKI9TaKHelIyYDOWY_JwHI_qKRZ89devZYf92ZBgjDrAusS7rEy8ZYXXqAmswjT0K-QB5D375xFegRvDxWTMxqPp0XNwsz6NR_YuaK2ytXwBrouvqzjPXlYS-xOBpTq2 |
| linkToPdf | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwrV3rb9MwELdGixAI8X4UBvgDqpi0qE5i5_ERdWTr1lUR3di-WY4fInQkpWmBfuNPx86rbEIgJD5G8dmxc3e-8_l-B8BrFAbKIU5iYSVDCycotILEY5bizFFMm9iIiLLYhD-ZBOfnYbwFhk0uTIUP0R64Gcko9bURcDkXarCJM2rroAqbmmCX7vUa6GISEtwB3b330em4DSZ4mFSF80LbpF-hTbRycLWPS7tT1yz099-Zno0lewvc_pabqHYxKy-1_7I1RXf_y6TugTu1ZQrfVqx0H2zJ7AHoxxW09XoXnmwytYpd2IfxBvR6_RD8aB5n-htME8gyAadMyeUa5goes8WXNMnhmw9pxkvFkkk4XV0obevCcTrPi_yzLOAo-1TeDct2YJrBoWHJBYwr7NcCnqXLj3CkFZjW00JTaTGEkd6YDcEjcBq9OxkeWHV1B4tro823lHCZ8GyOuEREelIJnChiB5xhXzksxAa5X2qPMGEO9gQnXHqhLYhikmOJlPsYdLI8k08BlMJn2HU440x3Ynuh9gptNwlcmWAfiaAHBs1fpbyGPjcVOC6o3aCdX1n2HthpKeYV7Mcf2vZLRmkbssXMXJfzCT2b7NNjb3pkk_2IHvbAdsNJtNYUBTXwRZ6p_Ob2AGxfaxk3gRuWyXxV0MAPiPY0iR7qScWA7ViOycNxfE9PseSrv34tPRzGBwRj1APWJd6lVeItLb1GTWCVpmFQIw8g_9k_j_AK3Ij3IjoeTY6eg5vNYTyyt0FnuVjJF-A6_7pMi8XLWmB_ArPLOjE |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Pharmacokinetics+and+Safety+of+Marqibo+%28Vincristine+Sulfate+Liposomes+Injection%29+in+Cancer+Patients+With+Impaired+Liver+Function&rft.jtitle=Journal+of+clinical+pharmacology&rft.au=Bedikian%2C+Agop+Y.&rft.au=Silverman%2C+Jeffrey+A.&rft.au=Papadopoulos%2C+Nicholas+E.&rft.au=Kim%2C+Kevin+B.&rft.date=2011-08-01&rft.pub=Blackwell+Publishing+Ltd&rft.issn=0091-2700&rft.eissn=1552-4604&rft.volume=51&rft.issue=8&rft.spage=1205&rft.epage=1212&rft_id=info:doi/10.1177%2F0091270010381499&rft.externalDBID=n%2Fa&rft.externalDocID=ark_67375_WNG_M6SK15GF_J |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=0091-2700&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=0091-2700&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=0091-2700&client=summon |