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

• Status: Completed
• Trial end date: 2019-01-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Hospital of Qingdao University
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).