Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
NCT ID: NCT01305967
Last Updated: 2011-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2003-01-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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SB injection
Infusion SBinjection of 21.87ml/m\^2, Intravenous route, 16times for 2.5 months
Eligibility Criteria
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Inclusion Criteria
* 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 \</= upper limit of normal
3. Aspartate Aminotransferase and/or Alanine Aminotransferase \</= 2 x upeer limit of normal
4. creatinine \</= 1.5 x upeer limit of normal
* Patients who have signed the informed consent form.
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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SBPharmaceutical IND, Co., LTD
INDUSTRY
Responsible Party
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SBPharmaceutical IND, Co., LTD
Principal Investigators
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Jae-yong Park, Professor
Role: PRINCIPAL_INVESTIGATOR
Kyungpook University Hospital
Seung-beom Han, Professor
Role: PRINCIPAL_INVESTIGATOR
Keimyung University Dongsan Medical Center
Chae-young Lee, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
Anyang Sam Medical Center
Locations
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Keimyung University Dongsan Hospital
Daegu, Jung-gu, South Korea
Kyungpook University Hospital
Deagu, Jung-gu, South Korea
Sam Anyang Medical Center
Anyang, Man-an-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Other Identifiers
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SB Injection
Identifier Type: -
Identifier Source: org_study_id
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