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Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Gastric Cancer

Primary Purpose

Gastric 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 Gastric Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Age of 18years or over
  • Patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage and with measurable lesions
  • Life expectancy >/= 5 months
  • Not available to any of resectable surgery or radiotherapy

  • Patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by

    1. Absolute neutrophil count(ANC)>/= 1.0 x 10^9/L, Platelet count >/= 75 x 10^9/L
    2. Total bilirubin < 2.0mg/dL
    3. Aspartate Aminotransferase(AST) and/or Alanine Aminotransferase(ALT) < 5 x Upper Limit Normal(ULN)
    4. creatinine < 2 x ULN
  • ECOG status 0 to 2
  • Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7days ago
  • Patients or their legal representatives who have signed the informed consent form.

Exclusion Criteria:

  • Known brain or spinal cord metastases
  • Patients who have received chemotherapy within the previous 4 weeks
  • Patients who have received radiotherapy related tp Gastric cancer within 4weeks
  • Patients who have participated in other clinical study within the previous 4weeks
  • Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
  • Human immunodeficiency virus(HIV) antibody (+)
  • Have active infection or serious concomitant systemic disorder incompatible with the study
  • Clinically hypertension or diabete mellitus not well controlled with medication
  • Clinically significant cardiac disease(e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction
  • Presence or history of malignancy other than Gastirc cancer within 5years
  • Have severe Neurologic or psychological disorder
  • Patients who have history of allery with this investigational drug(SB injection)
  • Obvious cognitive or physical impairment that would prevent participation

Sites / Locations

  • Inha University Hospital

Outcomes

Primary Outcome Measures

Evaluating Tumor Response Rate

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2011
Last Updated
February 27, 2011
Sponsor
SBPharmaceutical IND, Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT01305993
Brief Title
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Gastric Cancer
Official Title
Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Gastirc Cancer
Study Type
Interventional

2. Study Status

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

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 Gastric Cancer.
Detailed Description
All eligible patients will receive SB injection therapy for 6 cycles (14~21 days for each cycle). Efficacy will be evaluated every 3 cycles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric 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
26 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SB injection
Intervention Description
Infusion SBinjection of 21.87ml/m^2, IV route, 24times for 4 months
Primary Outcome Measure Information:
Title
Evaluating Tumor Response Rate
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Time Frame
4 months
Title
Evalute patient's performance by measuring Eastern Cooperative Oncology Group scale
Time Frame
4 months
Title
Determine duration of response rate by measuring time to progression
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 18years or over Patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage and with measurable lesions Life expectancy >/= 5 months Not available to any of resectable surgery or radiotherapy Patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by Absolute neutrophil count(ANC)>/= 1.0 x 10^9/L, Platelet count >/= 75 x 10^9/L Total bilirubin < 2.0mg/dL Aspartate Aminotransferase(AST) and/or Alanine Aminotransferase(ALT) < 5 x Upper Limit Normal(ULN) creatinine < 2 x ULN ECOG status 0 to 2 Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7days ago Patients or their legal representatives who have signed the informed consent form. Exclusion Criteria: Known brain or spinal cord metastases Patients who have received chemotherapy within the previous 4 weeks Patients who have received radiotherapy related tp Gastric cancer within 4weeks Patients who have participated in other clinical study within the previous 4weeks Pregnancy (absence to be confirmed by ß-hCG test) or lactation period Human immunodeficiency virus(HIV) antibody (+) Have active infection or serious concomitant systemic disorder incompatible with the study Clinically hypertension or diabete mellitus not well controlled with medication Clinically significant cardiac disease(e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction Presence or history of malignancy other than Gastirc cancer within 5years Have severe Neurologic or psychological disorder Patients who have history of allery with this investigational drug(SB injection) Obvious cognitive or physical impairment that would prevent participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong-oon Shin, Prof.
Phone
032-890-2548
Email
ywshin@inha.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-yeon Lee, RN/BSc
Phone
032-890-1133
Email
twindleclara@inha.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-oon Shin, Prof
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
State/Province
Jung-gu
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong-oon Shin, Prof.
Phone
032-890-2548
Email
ywshin@inha.ac.kr
First Name & Middle Initial & Last Name & Degree
Ji-yeon Lee, RN/BSc
Phone
032-890-1133
Email
twinkleclara@inha.com

12. IPD Sharing Statement

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

Learn more about this trial

Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Gastric Cancer

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