NCT05052437

PK and Drug Interaction Study of Utidelone Plus Capecitabine in Patients With Advanced Breast Cancer

Open, Multicenter, Phase Ic Clinical Study on the Pharmacokinetics and Drug Interactions of Utidelone Plus Capecitabine in Patients With Recurrent and Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is an open, multi-center, phase Ic clinical study on the pharmacokinetics and drug interactions of utidelone injection combined with capecitabine in patients with recurrent and metastatic breast cancer. The purpose of this trial is: 1. To evaluate the pharmacokinetic characteristics of continuous intravenous administration of utidelone. 2. To evaluate the drug interaction of utidelone and capecitabine.

Conditions

• Advanced and Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Utidelone Injection; capecitabine	8 patients will be assigned to utidelone plus capecitabine arm receiving utidelone plus capecitabine. Utidelone injection 30mg/m2/day, intravenously administered once a day for 5 consecutive days; capecitabine tablets, 1000mg/m2, orally, 2 times a day for 14 consecutive days. 21 days is a cycle
DRUG	Utidelone	8 patients will be assigned to utidelone arm and receive utidelone injection 30 mg/m2/day intravenously, once a day for 5 consecutive days in a 21-day cycle.

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-01-13
• Completion: 2021-02-19
• First posted: 2021-09-22
• Last updated: 2023-01-10

Locations

2 sites across 1 country: China