drugset
drugset / Trial / NCT01832298

Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor

NCT01832298 ↗

Phase 1 Completed 39 enrolled Haihe Biopharma Co., Ltd. Shanghai Institute of Materia Medica, Chinese Academy of Sciences · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-12
Primary completion
2016-03
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Simmitecan Small molecule 12.5 mg Intravenous
Subject Simmitecan Small molecule 25 mg Intravenous
Subject Simmitecan Small molecule 50 mg Intravenous
Subject Simmitecan Small molecule 80 mg Intravenous
Subject Simmitecan Small molecule 120 mg Intravenous
Subject Simmitecan Small molecule 160 mg Intravenous
Subject Simmitecan Small molecule 200 mg Intravenous

Indications

neoplasm