Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer

• Status: Unknown status
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung Cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SBPharmaceutical IND, Co., LTD

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 Aminotransferasenormal

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