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Trial Title:
Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
NCT ID:
NCT01305967
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SB injection
Description:
Infusion SBinjection of 21.87ml/m^2, Intravenous route, 16times for 2.5 months
Summary:
The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung
Cancer.
Detailed description:
All eligible patients will receive SB injection therapy for 4 cycles (14~21 days for each
cycle). SB injection treatment could be continue after completion of therapy cycles until
6th cycle. It depends on the investigator's decision and patient's will. Efficacy will be
evaluated every two cycles.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age of 18-70 years
- Patients with histologically or cytologically confirmed Non-Small Cell Lung Cancer
- Patients who had failed more than 1 cycle of standard therapy with advanced or
metasatic stage not available to any of resectable surgery or radiotherapy.
- Patients with measurable lesions
- Eatern Cooperative Oncolgy Group status 0 to 2.
- Life expectancy >/= 5 months
- Patients with adequate organ(heart, kidney, liver)and bone marrow function, as
defined by
1. Absolute neutrophil count >/= 1.5 x 10^9/L, Platelet count >/= 100 x 10^9/L
2. Total bilirubin
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Keimyung University Dongsan Hospital
Address:
City:
Daegu
Zip:
700-712
Country:
Korea, Republic of
Status:
Completed
Facility:
Name:
Kyungpook University Hospital
Address:
City:
Deagu
Zip:
700-721
Country:
Korea, Republic of
Status:
Completed
Facility:
Name:
Sam Anyang Medical Center
Address:
City:
Anyang
Zip:
430-733
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Cae-young Lee, MD
Phone:
031-467-9188
Email:
joy@bovie.org
Start date:
January 2003
Completion date:
June 2011
Lead sponsor:
Agency:
SBPharmaceutical IND, Co., LTD
Agency class:
Industry
Source:
SBPharmaceutical IND, Co., LTD
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01305967
http://www.sbp.com/
