Status:
COMPLETED
Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Patient Participation
Eligibility:
All Genders
28-69 years
Phase:
PHASE1
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 bioequiva...
Detailed Description
This was a multicenter, open, random, balanced, three-period, three-sequence and semi-repetitive cross study with 48 subjects. Eligible subjects were randomly assigned in a 1:1:1 ratio to receive one ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04420871
Start Date
December 10 2018
End Date
January 26 2019
Last Update
June 9 2020
Active Locations (1)
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1
Phase Ⅰ Clinical Research Center
Qingdao, Shandong, China, 266003