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

Primary Purpose

Non Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SB injection
Sponsored by
SBPharmaceutical IND, Co., LTD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keimyung University Dongsan Hospital
  • Kyungpook University Hospital
  • Sam Anyang Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Overall Best Response Rate

Secondary Outcome Measures

Determine duration of response rate by measuring time to progression
Pain Scores on the Visual Analog Scale
Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale

Full Information

First Posted
February 24, 2011
Last Updated
February 27, 2011
Sponsor
SBPharmaceutical IND, Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT01305967
Brief Title
Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
SBPharmaceutical IND, Co., LTD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SB injection
Intervention Description
Infusion SBinjection of 21.87ml/m^2, Intravenous route, 16times for 2.5 months
Primary Outcome Measure Information:
Title
Overall Best Response Rate
Time Frame
2.5 months
Secondary Outcome Measure Information:
Title
Determine duration of response rate by measuring time to progression
Time Frame
2.5 months
Title
Pain Scores on the Visual Analog Scale
Time Frame
2.5months
Title
Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale
Time Frame
2.5months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 Absolute neutrophil count >/= 1.5 x 10^9/L, Platelet count >/= 100 x 10^9/L Total bilirubin </= upper limit of normal Aspartate Aminotransferase and/or Alanine Aminotransferase </= 2 x upeer limit of normal 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chae-young Lee, Medical Doctor
Phone
031-467-9188
Email
joy@bovie.org
First Name & Middle Initial & Last Name or Official Title & Degree
A-young Shin, Registered Nurse
Phone
031-467-9767
Email
gmmi127@nate.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-yong Park, Professor
Organizational Affiliation
Kyungpook University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seung-beom Han, Professor
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chae-young Lee, Medical Doctor
Organizational Affiliation
Anyang Sam Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
State/Province
Jung-gu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Kyungpook University Hospital
City
Deagu
State/Province
Jung-gu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Sam Anyang Medical Center
City
Anyang
State/Province
Man-an-gu
ZIP/Postal Code
430-733
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cae-young Lee, MD
Phone
031-467-9188
Email
joy@bovie.org

12. IPD Sharing Statement

Links:
URL
http://www.sbp.com/
Description
SBP

Learn more about this trial

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

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