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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01305967
• Other study ID #: SB Injection
• Status: Recruiting
• Phase: Phase 2
• First received: February 24, 2011
• Last updated: February 27, 2011
• Start date: January 2003
• Est. completion date: June 2011

Study information

• Verified date: February 2011
• Source: SBPharmaceutical IND, Co., LTD
• Contact: Chae-young Lee, Medical Doctor
• Phone: 031-467-9188
• Email: joy[@]bovie.org
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 </= 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:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• SB injection
Infusion SBinjection of 21.87ml/m^2, Intravenous route, 16times for 2.5 months

Locations

Country	Name	City	State
Korea, Republic of	Sam Anyang Medical Center	Anyang	Man-an-gu
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu	Jung-gu
Korea, Republic of	Kyungpook University Hospital	Deagu	Jung-gu

Sponsors (1)

Lead Sponsor	Collaborator
SBPharmaceutical IND, Co., LTD

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Best Response Rate		2.5 months	No
Secondary	Determine duration of response rate by measuring time to progression		2.5 months	No
Secondary	Pain Scores on the Visual Analog Scale		2.5months	No
Secondary	Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale		2.5months	No

External Links

•   SBP