NCT05336721

A Phase II Study of Chiauranib in Combine With Capecitabine in TNBC

An Open Labelled, Multicenter-phase II Study of Chiauranib Combine With Capecitabine in Advanced Triple-negative Breast Cancer Failed to Prior Anthracyclines and Taxanes Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the preliminary efficacy and safety of chiauranib in combine with capecitabine in advanced triple-negative breast cancer failed to prior anthracyclines and taxanes therapy

Detailed description

Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases (VEGFR2, VEGFR1, VEGFR3,PDGFRa and c-Kit), mitosis-related kinase Aurora B and chronic inflammationrelated kinase CSF-1R in a high potency manner with the IC50 at a single-digit nanomolar range. In particular, Chiauranib showed very high selectivity in the kinase inhibition profile with little activity on off-target nonreceptor kinases, proteins, GPCR and ion channels, indicative of a better drug safety profile in terms of clinical relevance. This study including two phases: (1) dose-escalation , this phase using a 3+3design，9-18 patients will be enrolled and receive 25mg/35mg/50mg chiauranib and 1000mg/m2 capecitabine Q3W. (2) dose-expansion，About 20 patients will be enrolled and receive the MTD dose of chiauranib and 1000mg/m2 capecitabine Q3W. This study also to explore the PK variation and gene expression via blood samples

Conditions

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Chiauranib	25mg/35mg/50mg orally once daily
DRUG	capecitabine	1000mg/m2 on Days 1-14 in a repeating 21-day cycle

Timeline

• Start date: 2021-11-05
• Primary completion: 2024-10-31
• Completion: 2024-11-05
• First posted: 2022-04-20
• Last updated: 2025-03-24

Locations

4 sites across 1 country: China