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Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
Conditions
Non Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: SB injection
Type: Drug
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
3. Aspartate Aminotransferase and/or Alanine Aminotransferase
4. creatinine
- Patients who have signed the informed consent form.
Exclusion Criteria:
- 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
- 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
3. Aspartate Aminotransferase and/or Alanine Aminotransferase
4. creatinine
- Patients who have signed the informed consent form.
Exclusion Criteria:
- 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
Locations
Keimyung University Dongsan Hospital
Daegu, Jung-gu, Korea, Republic of
Kyungpook University Hospital
Status: Completed
Deagu, Jung-gu, Korea, Republic of
Sam Anyang Medical Center
Status: Completed
Anyang, Man-an-gu, Korea, Republic of
Status: Recruiting
Contact: Cae-young Lee, MD - 031-467-9188 - joy@bovie.org
Start Date
January 2003
Completion Date
June 2011
Sponsors
SBPharmaceutical IND, Co., LTD
Source
SBPharmaceutical IND, Co., LTD
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page