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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chae-young Lee, Medical Doctor
  • Phone Number: 031-467-9188
  • Email: joy@bovie.org

Study Contact Backup

  • Name: A-young Shin, Registered Nurse
  • Phone Number: 031-467-9767
  • Email: gmmi127@nate.com

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Best Response Rate
Time Frame: 2.5 months
2.5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SBPharmaceutical IND, Co., LTD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2003

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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