NCT01832298

Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor

Phase I Study of Simmitecan Hydrochloride for Injection in Patients With Advanced Solid Tumor：Tolerability and Pharmacokinetics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Haihe Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

RATIONAL: Simmitecan is an anticancer ester prodrug, which involves activation to chimmitecan. Chimmitecan，a novel CPT derivative, exhibited potent antitumor activities both in vitro and in vivo by inhibiting topoisomerase I. Also exerted comparable effects on topoisomerase I compared with topotecan and SN38 and possessed improved anticancer potency and pharmacologic profiles, compared with the clinically available CPT analogues. PURPOSE: to determine the maximum tolerated dose, the safety profile and pharmacokinetics of Simmitecan.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Simmitecan Hydrochloride for Injection	Either at 12.5 mg, 25 mg、50 mg、80 mg、120 mg、160 mg、200 mg

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-03-01
• Completion: 2016-08-01
• First posted: 2013-04-16
• Last updated: 2016-12-20

Locations

3 sites across 1 country: China