A Study of Sinotecean on Tolerance and Pharmacokinetics

Advanced Cancer Clinical Trial

Official title:

A Phase I Study of Sinotecean on Tolerance and Pharmacokinetics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02469883
• Other study ID #: XNTK-I-03
• Status: Recruiting
• Phase: Phase 1
• First received: March 22, 2015
• Last updated: June 9, 2015
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: Shusen Wang, doctor
• Email: wangshs[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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;

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• Sinotecean

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Assessments for Area Under Curve(AUC)	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	Day 1-2 Single Dose	No
Primary	Pharmacokinetic Assessments for Cmax		Day 1-2 Single Dose	No
Primary	Pharmacokinetic Assessments for Tmax		Day 1-2 Single Dose	No
Secondary	Objective Response Rate (ORR)		each 42 days up to intolerance the toxicity or progression of disease(PD) (up to 24 months)	No
Secondary	Maximum tolerated dose(MTD)		up to 24 months	No
Secondary	Dose-limiting toxicity(DLT)		up to 24 months	No