Dose selection and population pharmacokinetics of PEG-Intron in patients with chronic myelogenous leukaemia

British Journal of Clinical Pharmacology

Volumn 63, Issue 3, 2007, Pages 292-299

  Gupta, Samir ^a   Jen, Juif ^a   Kolz, Karen ^a   Cutler, David ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Chronic myelogenous leukaemia; Nonlinear mixed effects models; PEG Intron; Population pharmacokinetics

Indexed keywords

PEGINTERFERON ALPHA2B; RECOMBINANT ALPHA2B INTERFERON;

ADULT; AGED; ARTICLE; BLOOD SAMPLING; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COVARIANCE; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; DEMOGRAPHY; DRUG CLEARANCE; DRUG DOSE REGIMEN; DRUG EFFICACY; FEMALE; HEPATITIS C; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL ASSESSMENT; MULTICENTER STUDY; NONLINEAR SYSTEM; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; REPEATED DRUG DOSE; SAMPLE SIZE; STATISTICAL SIGNIFICANCE;

ADULT; AGED; ANTIVIRAL AGENTS; FEMALE; HUMANS; INTERFERON ALFA-2B; LEUKEMIA, MYELOID, CHRONIC; MALE; MIDDLE AGED; MODELS, BIOLOGICAL;

EID: 33846976523     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2006.02757.x     Document Type: Article

References (18)

1. Faderl S, Talpaz M, Estrov Z, Kantarjian HM. Chronic myelogenous leukemia. Biol Ther Ann Intern Med 1999; 131: 207.
2. Kantarjian HM, O'Brien S, Anderlini P, Talpaz M. Treatment of chronic myelogenous leukemia: current status and investigational options. Blood 1996; 87: 3069-81.
3. Talpaz M, Kantarjian H, Kurzrock R. Interferon-alpha produces sustained cytogenetic responses in chronic myelogenous leukemia. Ann Intern Med 1991; 114: 532.
4. Kantarjian HM, Smith TL, O'Brien S. Prolonged survival in chronic myelogenous leukemia after cytogenetic response to interferon-α therapy. Ann Intern Med 1995; 122: 254-61.
5. Glue P, Fang JW, Rouzier-Panis R, Raffanel C, Sabo R, Gupta SK, Salfi M, Jacobs S, and the Hepatitis C Study Group. PEG-interferon alfa-2b: pharmacokinetics, pharmacodynamics, safety and preliminary efficacy data. Clin Pharmacol Ther 2000; 68: 556-67.
6. Lindsay KL, Trepo C, Heintges T, Shiffman ML, Gordon SC, Hoefs JC, Schiff ER, Goodman ZD, Laughlin M, Yao R, Albrecht JK. A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C. Hepatology 2001; 34: 395-403.
7. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001; 358 (9286): 958-65.
8. Talpaz M, O'Brien S, Rose E, Gupta S, Shan J, Cortes J, Giles FJ, Faderl S, Kantarjian HM. Phase 1 study of polyethylene glycol formulation of interferon alpha-2B (Schering 54031) in Philadelphia chromosome-positive chronic myelogenous leukemia. Blood 2001; 98: 1708-13.
9. Jen JF, Glue P, Ezzet F, Chung C, Gupta SK, Jacobs S, Hajian G. Population pharmacokinetic analysis of pegylated interferon Alfa-2b and interferon alfa-2b in patients with chronic hepatitis C. Clin Pharmacol Ther 2001; 69: 407-21.
10. (Data on file) Population Pharmacokinetic Analysis of Pegylated Interferon Alfa-3b (Peg-Intron), Interferon Alfa-3b (Intron A) in Patients with Chronic Hepatitis C Enrolled in Study C/I97a-010. SPRI Report no. 2000. 00068050.
11. Jen JF, Chung C, Glue P, Ezzet F, Gupta S, Hajian G. Modeling the accumulation of drug concentration during treatment. AAPS Pharmsci 2000; 2: 4.
12. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31.
13. Beal SL, Sheiner LB. NONMEM Users Guides. UCSF: NONMEM Project Group 1992.
14. SAS/STAT User's Guide, Version 6. Cary, NC: SAS Institute 1990.
15. S-PLUS User's Manual, Version 2000. Seattle, WA: MathSoft Inc. 1999.
16. Gupta SK, Pittenger AL, Swan SK, Marbury TC, Tobillo E, Batra V, Sack M, Glue P, Jacobs S, Affrime M. Single dose pharmacokinetics and safety of pegylated interferon-α2b in patients with chronic renal dysfunction. J Clin Pharmacol 2002; 42: 1109-13.
17. Glue P, Fang JWS, Rouzier-Panis R, Raffanel C, Sabo R, Gupta SK, Salfi M, Jacobs S, and the Hapatitis C Intervention Therapy Group. Pegylated interferon-alpha2b: pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy data.Clin Pharmacol Ther 2000; 68: 556-67.
18. (Data on file) C98-026: A Randomized Phase II/III Trial of SCH 54031 PEG12000 Interferon alfa-2b (PEG Intron) vs. INTRON® A in Subjects with Newly Diagnosed CML. Schering-Plough Research Institute 2003.