drugset / Trial / NCT04728035

Study of Irinotecan Liposome Injection in Patients With Advanced Breast Cance

NCT04728035 ↗

Phase 1 Completed 119 enrolled CSPC Ouyi Pharmaceutical Co., Ltd.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is an open-label, single-arm, phase I study of irinotecan liposome injection in patients with advanced breast cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan liposome injection in patients with advanced breast cancer.

Timeline

Start
2021-05-31
Primary completion
2023-06-05
Completion
2024-06-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 50 mg/m2 Intravenous
Subject Irinotecan Small molecule 70 mg/m2 Intravenous
Subject Irinotecan Small molecule 90 mg/m2 Intravenous

Indications