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

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

October 15, 2020

Primary Completion Date

January 13, 2021

Study Completion Date

February 19, 2021

Conditions
Advanced and Metastatic Breast Cancer
Interventions
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.

Trial Locations (2)

Unknown

Hunan Cancer Hospital, Changsha

The Third Xiangya Hospital of Central South University, Changsha

All Listed Sponsors
collaborator

Chengdu Biostar Pharmaceuticals

INDUSTRY

lead

Beijing Biostar Pharmaceuticals Co., Ltd.

INDUSTRY