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

NCT05052437 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-01-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chengdu Biostar Pharmaceuticals

    collaborator INDUSTRY

  • Beijing Biostar Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Quchang Ouyang, MD · Hunan Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2021-01-13
Completion
2021-02-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05052437 on ClinicalTrials.gov