drugset / Trial / NCT05052437
PK and Drug Interaction Study of Utidelone Plus Capecitabine in Patients With Advanced Breast Cancer
Phase 1
Completed
16 enrolled
Beijing Biostar Pharmaceuticals Co., Ltd.
Chengdu Biostar Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2020-10-15
- Primary completion
- 2021-01-13
- Completion
- 2021-02-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Epothilone D | Small molecule | 30 mg/m2 | Intravenous |