- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01099124
Study of M2ES With Paclitaxel/Carboplatin (TC Regimen) in Advanced Non Small Cell Lung Cancer (NSCLC)
January 28, 2013 updated by: Tianjin Medical University Cancer Institute and Hospital
Single-center, Open Trail of Phase 1 of M2ES With TC Regimen in Advanced NSCLC
The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tianjin, China
- Tianjin Medical University Cancer Institude and Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18-70 years old;
- Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;
- No contraindication for chemotherapy;
- ECOG performance scale 0-2;
- No history of anti-angiogenesis therapy;
- Patients are voluntary to participate and sigh the informed contents.
Exclusion Criteria:
- Concurrent use of other anti-cancer agents;
- Allergic history to M2ES and biological agents;
- Pregnant or breast-feeding women;
- With other malignancy;
- With severe cardiopulmonary disease;
- Uncontrolled brain metastasis patients;
- Other conditions that are regarded for exclusion by the trialists.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: M2ES combined with chemotherapy
|
polyethylene glycol rh recombinant endostatin
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events incidence,including severe adverse events incidence
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor response rate and disease controlled rate
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kai LI, Tianjin Medical University Cancer Institude and Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
February 24, 2010
First Submitted That Met QC Criteria
April 5, 2010
First Posted (Estimate)
April 6, 2010
Study Record Updates
Last Update Posted (Estimate)
January 29, 2013
Last Update Submitted That Met QC Criteria
January 28, 2013
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMU-CIH-CTI-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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