A rapid and sensitive method for determination of sorafenib in human plasma using a liquid chromatography/tandem mass spectrometry assay

Zhao, Ming; Rudek, Michelle A.; He, Ping; Hafner, Frank-Thorsten; Radtke, Martin; Wright, John J.; Smith, B. Douglas; Messersmith, Wells A.; Hidalgo, Manuel; Baker, Sharyn D.

doi:10.1016/j.jchromb.2006.06.005

Cited by 48 publications

(49 citation statements)

References 16 publications

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“…The plasma concentrations of sorafenib and its N-oxide, desmethyl, and N-oxide desmethyl metabolites were measured by high-performance liquid chromatography with tandem mass spectrometry by Bayer Pharmaceuticals (Hamden, CT). 13 The fraction of sorafenib not bound to plasma proteins was measured in vitro by Bayer Pharmaceuticals (Wuppertal, Germany) with C 14 -labeled sorafenib in patients' plasma (sample at 4 hours after test dose) according to a published method.…”

Section: Dose-escalation Rulesmentioning

confidence: 99%

Phase I and Pharmacokinetic Study of Sorafenib in Patients With Hepatic or Renal Dysfunction: CALGB 60301

Miller

Murry

Owzar

et al. 2009

JCO

199

154

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Purpose We sought to characterize the pharmacokinetics (PK) and determine a tolerable dose of oral sorafenib in patients with hepatic or renal dysfunction. Patients and Methods Patients were assigned to one of nine cohorts: cohort 1, bilirubin ≤ upper limit of normal (ULN) and AST ≤ ULN and creatinine clearance (CC) ≥ 60 mL/min; cohort 2, bilirubin more than ULN but ≤ 1.5× ULN and/or AST more than ULN; cohort 3, CC between 40 and 59 mL/min; cohort 4, bilirubin more than 1.5× ULN to ≤ 3× ULN (any AST); cohort 5, CC between 20 and 39 mL/min; cohort 6, bilirubin more than 3× ULN to 10× ULN (any AST); cohort 7, CC less than 20 mL/min; cohort 8, albumin less than 2.5 mg/dL (any bilirubin/AST); and cohort 9, hemodialysis. Sorafenib was administered as a 400-mg dose on day 1 for PK, and continuous daily dosing started on day 8. Results Of 150 registered patients, 138 patients were treated. With the exception of cohorts 6 and 7, at least 12 patients per cohort were assessable, and the dose level with prospectively defined dose-limiting toxicity in less than one third of patients by day 29 was considered tolerable. No significant associations between the sorafenib PK and cohort were found. Conclusion We recommend the following empiric sorafenib starting doses by cohort: cohort 1, 400 mg twice a day; cohort 2, 400 mg twice a day; cohort 3, 400 mg twice a day; cohort 4, 200 mg twice a day; cohort 5, 200 mg twice a day; cohort 6, not even 200 mg every third day tolerable; cohort 7, not defined; cohort 8, 200 mg each day; and cohort 9, 200 mg each day.

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Section: Dose-escalation Rulesmentioning

confidence: 99%

Phase I and Pharmacokinetic Study of Sorafenib in Patients With Hepatic or Renal Dysfunction: CALGB 60301

Miller

Murry

Owzar

et al. 2009

JCO

199

154

View full text Add to dashboard Cite

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“…The only published detailed LC-MS-MS method by M. Zhao et al for quantification of sorafenib uses 100 μl of plasma and has a chromatographic run time of 6 minutes with LLOQ of 7.3 ng/mL [4]. Here, we describe a rapid, sensitive and specific LC-MS-MS assay for the determination of sorafenib in human plasma which offers the advantages of shorter run time (4 minutes) and lower LLOQ (5 ng/ml) with a decreased plasma volume requirement (50 μL).…”

Section: Introductionmentioning

confidence: 99%

Development of a rapid and sensitive LC–MS/MS assay for the determination of sorafenib in human plasma

Jain

Gardner

Venitz

et al. 2008

Journal of Pharmaceutical and Biomedical Analysis

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A rapid and sensitive liquid chromatography/tandem mass spectrometric (LC/MS/MS) assay was developed for the quantitative determination of sorafenib in human plasma. Sample pretreatment involved simple protein precipitation by the addition of 0.5 mL acetonitrile, containing internal standard ([ 2 H 3 , 15 N] sorafenib), to 50 μL of plasma sample volume. Separation was achieved on a Waters SymmetryShield RP8 (2.1×50 mm, 3.5 μm) column at room temperature using an isocratic elution method with acetonitrile/0.

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“…The LC/MS/MS assay uses a simple sample pre-treatment and meets commonly accepted criteria for precision, accuracy and recovery. The sensitivity of the method for sorafenib is in the same range as previous bioanalytical LC/MS/MS assays for only sorafenib [5][6][7]. Sorafenib and sorafenib-glucuronide are stable under all investigated conditions.…”

Section: Discussionmentioning

confidence: 74%

“…Two validated liquid chromatography-tandem mass spectrometric (LC/MS/MS) methods capable of quantifying sorafenib in human plasma were reported recently [6,7]. Both assays use protein precipitation as a sample pre-treatment technique.…”

Section: Introductionmentioning

confidence: 99%

Liquid chromatography–tandem mass spectrometric assay for sorafenib and sorafenib–glucuronide in mouse plasma and liver homogenate and identification of the glucuronide metabolite

Sparidans

Vlaming

Lagas

et al. 2009

Journal of Chromatography B

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A rapid and sensitive method for determination of sorafenib in human plasma using a liquid chromatography/tandem mass spectrometry assay

Cited by 48 publications

References 16 publications

Phase I and Pharmacokinetic Study of Sorafenib in Patients With Hepatic or Renal Dysfunction: CALGB 60301

Phase I and Pharmacokinetic Study of Sorafenib in Patients With Hepatic or Renal Dysfunction: CALGB 60301

Development of a rapid and sensitive LC–MS/MS assay for the determination of sorafenib in human plasma

Liquid chromatography–tandem mass spectrometric assay for sorafenib and sorafenib–glucuronide in mouse plasma and liver homogenate and identification of the glucuronide metabolite

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