Open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetics and safety differences between two docetaxel products, CKD-810 and Taxotere injection, in patients with advanced solid cancer

Eun Kyung Cho, Ji Young Park, Kyung Hee Lee, Hong Suk Song, Young Joo Min, Yeul Hong Kim, Jin Hyoung Kang

Research output: Contribution to journalArticle

Abstract

Purpose: The aim of this study was to compare CKD-810 (test docetaxel) with Taxotere® (reference docetaxel) in terms of pharmacokinetics and safety for patients with advanced or metastatic carcinoma. Methods: A randomized, open-label, two-way crossover study was conducted in eligible patients. Patients received with reference or test drugs of 75 mg/m2 docetaxel by intravenous infusion for 60 min in the first period and the alternative drug in the second period with a washout of 3 weeks. Plasma concentrations of docetaxel were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. Pharmacokinetic parameters, including the maximum plasma concentration (C max) and the area under the concentration-time curve (AUC), were determined by non-compartmental analysis. Results: A total of 44 patients were included in the study, 21 patients received test drug and 23 received reference drug for the first cycle. The C max of docetaxel was 2,658.77 ng/mL for test drug and 2,827.60 ng/mL for reference drug, and two drugs showed no difference with a statistical significance. Time to reach C max (T max) of CKD-810 (0.94 h) versus reference docetaxel (0.97 h) was also not significantly different. Other pharmacokinetic parameters including the plasma AUC, elimination half-life, and total body clearance exhibited similar values without a significant difference. The most common grade 3 or 4 toxicity was neutropenia (CKD-810 19.5 or 29.3 %; reference docetaxel 14.6 or 41.5 %). Febrile neutropenia was experienced by only one patient in each group. Two patients died of progression of disease during the study. Conclusion: Docetaxel anhydrous CKD-810 use with patients suffering advanced or metastatic solid malignancies was equivalent to reference docetaxel in terms of pharmacokinetic parameters and safety profile. Additionally, the test and reference drug met the regulatory criteria for pharmacokinetic equivalence.

Original languageEnglish
Pages (from-to)9-16
Number of pages8
JournalCancer Chemotherapy and Pharmacology
Volume73
Issue number1
DOIs
Publication statusPublished - 2014 Jan 1

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docetaxel
Pharmacokinetics
Cross-Over Studies
Labels
Safety
Injections
Neoplasms
Pharmaceutical Preparations
Plasmas
Febrile Neutropenia
High performance liquid chromatography

Keywords

  • CKD-810
  • Docetaxel
  • Pharmacokinetics
  • Polysorbate

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Toxicology

Cite this

Open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetics and safety differences between two docetaxel products, CKD-810 and Taxotere injection, in patients with advanced solid cancer. / Cho, Eun Kyung; Park, Ji Young; Lee, Kyung Hee; Song, Hong Suk; Min, Young Joo; Kim, Yeul Hong; Kang, Jin Hyoung.

In: Cancer Chemotherapy and Pharmacology, Vol. 73, No. 1, 01.01.2014, p. 9-16.

Research output: Contribution to journalArticle

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abstract = "Purpose: The aim of this study was to compare CKD-810 (test docetaxel) with Taxotere{\circledR} (reference docetaxel) in terms of pharmacokinetics and safety for patients with advanced or metastatic carcinoma. Methods: A randomized, open-label, two-way crossover study was conducted in eligible patients. Patients received with reference or test drugs of 75 mg/m2 docetaxel by intravenous infusion for 60 min in the first period and the alternative drug in the second period with a washout of 3 weeks. Plasma concentrations of docetaxel were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. Pharmacokinetic parameters, including the maximum plasma concentration (C max) and the area under the concentration-time curve (AUC), were determined by non-compartmental analysis. Results: A total of 44 patients were included in the study, 21 patients received test drug and 23 received reference drug for the first cycle. The C max of docetaxel was 2,658.77 ng/mL for test drug and 2,827.60 ng/mL for reference drug, and two drugs showed no difference with a statistical significance. Time to reach C max (T max) of CKD-810 (0.94 h) versus reference docetaxel (0.97 h) was also not significantly different. Other pharmacokinetic parameters including the plasma AUC, elimination half-life, and total body clearance exhibited similar values without a significant difference. The most common grade 3 or 4 toxicity was neutropenia (CKD-810 19.5 or 29.3 {\%}; reference docetaxel 14.6 or 41.5 {\%}). Febrile neutropenia was experienced by only one patient in each group. Two patients died of progression of disease during the study. Conclusion: Docetaxel anhydrous CKD-810 use with patients suffering advanced or metastatic solid malignancies was equivalent to reference docetaxel in terms of pharmacokinetic parameters and safety profile. Additionally, the test and reference drug met the regulatory criteria for pharmacokinetic equivalence.",
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T1 - Open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetics and safety differences between two docetaxel products, CKD-810 and Taxotere injection, in patients with advanced solid cancer

AU - Cho, Eun Kyung

AU - Park, Ji Young

AU - Lee, Kyung Hee

AU - Song, Hong Suk

AU - Min, Young Joo

AU - Kim, Yeul Hong

AU - Kang, Jin Hyoung

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N2 - Purpose: The aim of this study was to compare CKD-810 (test docetaxel) with Taxotere® (reference docetaxel) in terms of pharmacokinetics and safety for patients with advanced or metastatic carcinoma. Methods: A randomized, open-label, two-way crossover study was conducted in eligible patients. Patients received with reference or test drugs of 75 mg/m2 docetaxel by intravenous infusion for 60 min in the first period and the alternative drug in the second period with a washout of 3 weeks. Plasma concentrations of docetaxel were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. Pharmacokinetic parameters, including the maximum plasma concentration (C max) and the area under the concentration-time curve (AUC), were determined by non-compartmental analysis. Results: A total of 44 patients were included in the study, 21 patients received test drug and 23 received reference drug for the first cycle. The C max of docetaxel was 2,658.77 ng/mL for test drug and 2,827.60 ng/mL for reference drug, and two drugs showed no difference with a statistical significance. Time to reach C max (T max) of CKD-810 (0.94 h) versus reference docetaxel (0.97 h) was also not significantly different. Other pharmacokinetic parameters including the plasma AUC, elimination half-life, and total body clearance exhibited similar values without a significant difference. The most common grade 3 or 4 toxicity was neutropenia (CKD-810 19.5 or 29.3 %; reference docetaxel 14.6 or 41.5 %). Febrile neutropenia was experienced by only one patient in each group. Two patients died of progression of disease during the study. Conclusion: Docetaxel anhydrous CKD-810 use with patients suffering advanced or metastatic solid malignancies was equivalent to reference docetaxel in terms of pharmacokinetic parameters and safety profile. Additionally, the test and reference drug met the regulatory criteria for pharmacokinetic equivalence.

AB - Purpose: The aim of this study was to compare CKD-810 (test docetaxel) with Taxotere® (reference docetaxel) in terms of pharmacokinetics and safety for patients with advanced or metastatic carcinoma. Methods: A randomized, open-label, two-way crossover study was conducted in eligible patients. Patients received with reference or test drugs of 75 mg/m2 docetaxel by intravenous infusion for 60 min in the first period and the alternative drug in the second period with a washout of 3 weeks. Plasma concentrations of docetaxel were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. Pharmacokinetic parameters, including the maximum plasma concentration (C max) and the area under the concentration-time curve (AUC), were determined by non-compartmental analysis. Results: A total of 44 patients were included in the study, 21 patients received test drug and 23 received reference drug for the first cycle. The C max of docetaxel was 2,658.77 ng/mL for test drug and 2,827.60 ng/mL for reference drug, and two drugs showed no difference with a statistical significance. Time to reach C max (T max) of CKD-810 (0.94 h) versus reference docetaxel (0.97 h) was also not significantly different. Other pharmacokinetic parameters including the plasma AUC, elimination half-life, and total body clearance exhibited similar values without a significant difference. The most common grade 3 or 4 toxicity was neutropenia (CKD-810 19.5 or 29.3 %; reference docetaxel 14.6 or 41.5 %). Febrile neutropenia was experienced by only one patient in each group. Two patients died of progression of disease during the study. Conclusion: Docetaxel anhydrous CKD-810 use with patients suffering advanced or metastatic solid malignancies was equivalent to reference docetaxel in terms of pharmacokinetic parameters and safety profile. Additionally, the test and reference drug met the regulatory criteria for pharmacokinetic equivalence.

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