A Study of Sinotecean on Tolerance and Pharmacokinetics

Phase 1

• Conditions: Advanced Cancer
• Interventions: Drug: Sinotecean

• Registration Number: NCT02469883
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary

This study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of Sinotecean.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-22
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-09
• Last Update Submitted: 2015-06-09
• Study First Posted: 2015-06-12
• Last Update Posted: 2015-06-12
• Primary Completion: 2016-08
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• late malignant tumor patients diagnosed with the pathological and/or cytological;
• lack of the standard treatment or treatment failure;
• 18-65years, ECOG:0-1,expected survival period >3 months;
• main organs function is normal;
• signed and dated informed consent

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Exclusion Criteria

• participated in other clinical trials in four weeks;
• currently under other effective treatment;
• end of anti-tumor treatment within 4 weeks(end of Nitrosourea/Mitomycin within 6 weeks);
• AE ≥ Grade 2(according to NCI-CTC 4.0),except hair loss;
• with ischemic heart disease, heart failure, severe arrhythmia, cerebrovascular disease, asthma, severe infections, active peptic ulcer;
• urine protein: ++, and urinary in 24 hours > 1.0g;
• uncontrolled primary or metastatic brain;
• have immunodeficiency history;
• according to the researcher's judgment,there are concomitant diseases which will seriously endanger the patients or obstruct the patients to complete the clinical trial;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sinotecean	Sinotecean	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Assessments for Area Under Curve（AUC）	Day 1-2 Single Dose	To collect point with single drug:5 min/10 min/15 min/30 min/1 h/2h/4h/6 h/8h/10h/12 h/24 h/32h/48 h
Pharmacokinetic Assessments for Tmax	Day 1-2 Single Dose
Pharmacokinetic Assessments for Cmax	Day 1-2 Single Dose

Secondary Outcome Measures

Name	Time	Method
Maximum tolerated dose(MTD)	up to 24 months
Objective Response Rate （ORR)	each 42 days up to intolerance the toxicity or progression of disease（PD） (up to 24 months)
Dose-limiting toxicity(DLT)	up to 24 months

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China