Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer

NCT04420871 | Completed Phase 1 DMC

• 1 other identifier: QL-KPTB-150
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, randomized, open-label, three-period, and reference-replicated crossover study was conducted in 48 patients with colorectal or breast cancer under fed conditions to assess the bioequivalence between two formulations of capecitabine.

Conditions

Patient Participation

Keywords

Capecitabine; Bioequivalence; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  Evaluation of Peak Plasma Concentration (Cmax)

  18 days

• Area under the plasma concentration versus time curve (AUC)0-t

  Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

  18 days

• Area under the plasma concentration versus time curve (AUC)0-∞

  Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞

  18 days

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  18 days

Study Arms (2)

capecitabine reference formulation at a single dose of 150 mg

ACTIVE COMPARATOR

150 mg of Xeloda® produced by Genentech USA, Inc., a subsidiary of the company, was used as the reference intervention in this study.

Drug: 150 mg of Xeloda®

capecitabine test formulation at a single dose of 150 mg

EXPERIMENTAL

The tablet of 150 mg of capecitabine from Qilu Pharmaceutical Co., Ltd. (17H0053DE4, Jinan, Shandong Province, China) was used as the test formulation.

Drug: 150 mg of capecitabine

Interventions

150 mg of Xeloda® DRUG

Subjects were allocated to one of three groups randomly and equally with a 1-day wash time period. 150 mg of Xeloda® produced by Genentech USA, Inc., a subsidiary of the company, was used as the reference intervention in this study.The subjects randomly received single oral administration of 150 mg of Xeloda®.

capecitabine reference formulation at a single dose of 150 mg

150 mg of capecitabine DRUG

Subjects were allocated to one of three groups randomly and equally with a 1-day wash time period.The tablet of 150 mg of capecitabine from Qilu Pharmaceutical Co., Ltd. (17H0053DE4, Jinan, Shandong Province, China) was used as the test formulation.The subjects randomly received single oral administration of 150 mg of capecitabine.

capecitabine test formulation at a single dose of 150 mg

Eligibility Criteria

• Age: 28 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed colorectal or breast cancer receiving capecitabine monotherapy or combination chemotherapy.
• Eligible patients were within 18-70 years of age.
• ECOG score was 0-2.
• Left ventricular ejection fraction (LVEF) \> 50%.
• There was no serious persistent toxicity to capecitabine treatment before screening (laboratory tests ≤ grade 1 (NCI CTCAE 5.0 standard)
• Hand-foot syndrome ≤ grade 2 after recovery from the previous treatment period).

You may not qualify if:

• Patients were known allergy to fluorouracil or 5-fluorouracil.
• Patients with complete lack of known dihydropyrimidine dehydrogenase (DPD) activity.
• Patients with abnormal hepatic and renal function (serum creatinine≤ 1.5 ×ULN; CLcr ≥ 51 mL/min; bilirubin≤ 1.5 ×ULN; AST, ALT≤2.5×ULN)
• Needed to accept phenytoin, warfarin, other coumarin derivatives anticoagulants, folic acid, and CYP2C9 substrates during the research.
• Patients with brain metastases or other metastases of the central nervous system (except those who were treated at least 6 months prior to the start of the study and were stable and asymptomatic).

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Phase Ⅰ Clinical Research Center

Qingdao, Shandong, 266003, China

Location

Related Publications (1)

• Wang CJ, Li T, Lin PP, Tao Y, Jiang X, Li X, Wen Q, Cao Y. Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients with Colorectal or Breast Cancer Under Fed Conditions: A Multicenter, Randomized, Open-Label, Three-Period, and Reference-Replicated Crossover Study. Adv Ther. 2021 Sep;38(9):4798-4814. doi: 10.1007/s12325-021-01817-4. Epub 2021 Aug 4.

  PMID: 34347254 DERIVED

MeSH Terms

Conditions

Patient Participation

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• yu Cao, Doctor

  the study director of phase I clinical research center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter, randomized, open-label, three-period, and reference-replicated crossover study

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: December 10, 2018
• Primary Completion: December 28, 2018
• Study Completion: January 26, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)