Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
Phase Ⅱa,Open Label,Multicenter Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
1 other identifier
interventional
20
1 country
3
Brief Summary
The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung Cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2003
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 24, 2011
CompletedFirst Posted
Study publicly available on registry
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMarch 1, 2011
February 1, 2011
8.3 years
February 24, 2011
February 27, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Best Response Rate
2.5 months
Secondary Outcomes (3)
Determine duration of response rate by measuring time to progression
2.5 months
Pain Scores on the Visual Analog Scale
2.5months
Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale
2.5months
Interventions
Infusion SBinjection of 21.87ml/m\^2, Intravenous route, 16times for 2.5 months
Eligibility Criteria
You may qualify if:
- 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
- Absolute neutrophil count \>/= 1.5 x 10\^9/L, Platelet count \>/= 100 x 10\^9/L
- Total bilirubin \</= upper limit of normal
- Aspartate Aminotransferase and/or Alanine Aminotransferase \</= 2 x upeer limit of normal
- creatinine \</= 1.5 x upeer limit of normal
- Patients who have signed the informed consent form.
You may not qualify if:
- Female volunteers admitted to the study must be using a reliable means of contraception
- Received radiation therapy within 6 weeks before randomization
- Known brain or spinal cord metastases
- Have acute infection
- Have active infection or serious concomitant systemic disorder incompatible with the study
- Presence or history of malignancy other than Non-Small Cell Lung Cancer
- Have severe neurologic or psychological disorder
- Patients who have to receive other chemo-radiotherapy or immunotherapy
- Patients who have received chemotherapy within the previous 30 days
- Patients who are candidates for combined modality treatment.
- Patients who have participated in a clinical study within the previous 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Keimyung University Dongsan Hospital
Daegu, Jung-gu, 700-712, South Korea
Kyungpook University Hospital
Deagu, Jung-gu, 700-721, South Korea
Sam Anyang Medical Center
Anyang, Man-an-gu, 430-733, South Korea
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-yong Park, Professor
Kyungpook University Hospital
- PRINCIPAL INVESTIGATOR
Seung-beom Han, Professor
Keimyung University Dongsan Medical Center
- PRINCIPAL INVESTIGATOR
Chae-young Lee, Medical Doctor
Anyang Sam Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 24, 2011
First Posted
March 1, 2011
Study Start
January 1, 2003
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
March 1, 2011
Record last verified: 2011-02