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Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor

NCT01832298 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2016-12-20

No results posted yet for this study

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

DRUG

Simmitecan Hydrochloride for Injection

Either at 12.5 mg, 25 mg、50 mg、80 mg、120 mg、160 mg、200 mg

Sponsors & Collaborators

  • Shanghai Institute of Materia Medica, Chinese Academy of Sciences

    collaborator OTHER

  • Haihe Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jinwan Wang, M.D. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Aiping Zhou, M.D. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Yong Xu, M.D. · West China Hospital

  • Qingyuan Zhang, M.D. · The Tumor Hospital Affiliated to Harbin Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-03-31
Completion
2016-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01832298 on ClinicalTrials.gov