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

Intervention / Treatment

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)

20

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

No

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)

March 1, 2011

Last Update Submitted That Met QC Criteria

February 27, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB Injection

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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