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

February 27, 2011 updated by: SBPharmaceutical IND, Co., LTD

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

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

Study Overview

Status

Unknown

Conditions

Non Small Cell Lung Cancer

Intervention / Treatment

Drug: SB injection

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

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- Jung-gu
  - Daegu, Jung-gu, Korea, Republic of, 700-712
    - Completed
    - Keimyung University Dongsan Hospital
  - Deagu, Jung-gu, Korea, Republic of, 700-721
    - Completed
    - Kyungpook University Hospital
- Man-an-gu
  - Anyang, Man-an-gu, Korea, Republic of, 430-733
    - Recruiting
    - Sam Anyang Medical Center
    - Contact:
      
      Cae-young Lee, MD
      
      Phone Number: 031-467-9188
      
      Email: joy@bovie.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Best Response Rate Time Frame: 2.5 months	2.5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine duration of response rate by measuring time to progression Time Frame: 2.5 months	2.5 months
Pain Scores on the Visual Analog Scale Time Frame: 2.5months	2.5months
Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale Time Frame: 2.5months	2.5months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 27, 2011

First Posted (Estimate)

March 1, 2011

Study Record Updates

Last Update Posted (Estimate)