Spots Global Cancer Trial Database for Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor
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Trial Identification
Brief Title: Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor
Official Title: Phase I Study of Simmitecan Hydrochloride for Injection in Patients With Advanced Solid Tumor：Tolerability and Pharmacokinetics
Study ID: NCT01832298
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
The tumor hospital affiliated to Harbin medical university, Harbin, Heilongjiang, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Contact Details
Name: Jinwan Wang, M.D.
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Aiping Zhou, M.D.
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Yong Xu, M.D.
Affiliation: West China Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Qingyuan Zhang, M.D.
Affiliation: The Tumor Hospital Affiliated to Harbin Medical University
Role: PRINCIPAL_INVESTIGATOR
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