NCT04728035

Study of Irinotecan Liposome Injection in Patients With Advanced Breast Cance

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Irinotecan Liposome Injection in Patients With Advanced Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, single-arm, phase I study with a dose-escalation phase (part 1) and a dose-expansion phase (part 2). In part 1, patients will receive irinotecan liposome injection (CSPC) at the initial starting dose until progression or unacceptable toxicity. Dosages will be escalated by certain increments in subsequent cohorts. Once the appropriate dose has been established in part 1, patients will be enrolled into two expansion cohorts in part 2.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan Liposome Injection	Irinotecan Liposome Injection

Timeline

• Start date: 2021-05-31
• Primary completion: 2023-06-05
• Completion: 2024-06-05
• First posted: 2021-01-28
• Last updated: 2024-07-26

Locations

1 site across 1 country: China