NCT05086848

A Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV in Advanced Solid Tumors

A Phase Ib Study to Evaluate Tolerability, Safety and Pharmacokinetics of Irinotecan Hydrochloride Liposome Injection in Combination With 5-FU/LV in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a dose-escalation and expansion, open label, single centre, phase Ib study. In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection in combination with 5-FU/LV were studied in patients with advanced solid tumors. Meanwhile, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Irinotecan liposome、5-fluorouracil、Leucovorin	Irinotecan liposome、5-fluorouracil、Leucovorin

Timeline

• Start date: 2016-05-05
• Primary completion: 2018-06-06
• Completion: 2018-06-06
• First posted: 2021-10-21
• Last updated: 2021-10-21

Locations

1 site across 1 country: China