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A Study of Sinotecean on Tolerance and Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469883
Recruitment Status : Unknown
Verified June 2015 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Recruitment status was:  Recruiting
First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Sinotecean Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Sinotecean on Tolerance and Pharmacokinetics
Study Start Date : March 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Sinotecean Drug: Sinotecean



Primary Outcome Measures :
  1. Pharmacokinetic Assessments for Area Under Curve(AUC) [ Time Frame: 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

  2. Pharmacokinetic Assessments for Cmax [ Time Frame: Day 1-2 Single Dose ]
  3. Pharmacokinetic Assessments for Tmax [ Time Frame: Day 1-2 Single Dose ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: each 42 days up to intolerance the toxicity or progression of disease(PD) (up to 24 months) ]
  2. Maximum tolerated dose(MTD) [ Time Frame: up to 24 months ]
  3. Dose-limiting toxicity(DLT) [ Time Frame: up to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469883


Contacts
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Contact: Shusen Wang, doctor wangshs@mail.sysu.edu.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Shusen Wang, doctor       wangshs@mail.sysu.edu.cn   
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT02469883    
Other Study ID Numbers: XNTK-I-03
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015