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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01305967
Recruitment Status : Unknown
Verified February 2011 by SBPharmaceutical IND, Co., LTD.
Recruitment status was:  Recruiting
First Posted : March 1, 2011
Last Update Posted : March 1, 2011
Information provided by:
SBPharmaceutical IND, Co., LTD

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

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: SB injection Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2003
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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

Primary Outcome Measures :
  1. Overall Best Response Rate [ Time Frame: 2.5 months ]

Secondary Outcome Measures :
  1. Determine duration of response rate by measuring time to progression [ Time Frame: 2.5 months ]
  2. Pain Scores on the Visual Analog Scale [ Time Frame: 2.5months ]
  3. Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale [ Time Frame: 2.5months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01305967

Contact: Chae-young Lee, Medical Doctor 031-467-9188
Contact: A-young Shin, Registered Nurse 031-467-9767

Korea, Republic of
Keimyung University Dongsan Hospital Completed
Daegu, Jung-gu, Korea, Republic of, 700-712
Kyungpook University Hospital Completed
Deagu, Jung-gu, Korea, Republic of, 700-721
Sam Anyang Medical Center Recruiting
Anyang, Man-an-gu, Korea, Republic of, 430-733
Contact: Cae-young Lee, MD    031-467-9188   
Sponsors and Collaborators
SBPharmaceutical IND, Co., LTD
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

Additional Information:
SBP  This link exits the site

Responsible Party: Lee Dong-heum / executive director, SBPharmaceutical IND, Co., LTD Identifier: NCT01305967     History of Changes
Other Study ID Numbers: SB Injection
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms