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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by SBPharmaceutical IND, Co., LTD.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
SBPharmaceutical IND, Co., LTD
ClinicalTrials.gov Identifier:
NCT01305967
First received: February 24, 2011
Last updated: February 27, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: SB injection
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SBPharmaceutical IND, Co., LTD:

Primary Outcome Measures:
  • Overall Best Response Rate [ Time Frame: 2.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine duration of response rate by measuring time to progression [ Time Frame: 2.5 months ] [ Designated as safety issue: No ]
  • Pain Scores on the Visual Analog Scale [ Time Frame: 2.5months ] [ Designated as safety issue: No ]
  • Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale [ Time Frame: 2.5months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2003
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB injection
    Infusion SBinjection of 21.87ml/m^2, Intravenous route, 16times for 2.5 months
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </= 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305967

Contacts
Contact: Chae-young Lee, Medical Doctor 031-467-9188 joy@bovie.org
Contact: A-young Shin, Registered Nurse 031-467-9767 gmmi127@nate.com

Locations
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    joy@bovie.org   
Sponsors and Collaborators
SBPharmaceutical IND, Co., LTD
Investigators
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
  More Information

Additional Information:
SBP  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Lee Dong-heum / executive director, SBPharmaceutical IND, Co., LTD
ClinicalTrials.gov Identifier: NCT01305967     History of Changes
Other Study ID Numbers: SB Injection
Study First Received: February 24, 2011
Last Updated: February 27, 2011
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014