A Study of Sinotecean on Tolerance and Pharmacokinetics

A Phase I Study of Sinotecean on Tolerance and Pharmacokinetics

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.

Study Overview

• Status: Unknown
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: Sinotecean

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Shusen Wang, doctor; Email: wangshs@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sinotecean	Drug: Sinotecean

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pharmacokinetic Assessments for Cmax		Day 1-2 Single Dose
Pharmacokinetic Assessments for Tmax		Day 1-2 Single Dose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: March 22, 2015
• First Submitted That Met QC Criteria: June 9, 2015
• First Posted (Estimate): June 12, 2015

Study Record Updates

• Last Update Posted (Estimate): June 12, 2015
• Last Update Submitted That Met QC Criteria: June 9, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: XNTK-I-03