Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SB injection
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Age of 18years or over
- Patients who had failed more than 1 cycle of standard therapy with advanced or metastatic 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 >/= 1.0 x 10^9/L, Platelet count >/= 75 x 10^9/L
- Total bilirubin < 2.0 mg/dL
- Aspartate Aminotransferase and/or Aspartate Aminotransferase < 5 x Upper Limit Normal
- creatinine < 2 x Upper Limit Normal
- 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:
- Have inflammatory bowel diseases
- Have severe diarrhea or ileus
- Previous total colectomy
- Have ileostomy
- Known brain or spinal cord metastases
- Patients who have received chemotherapy within the previous 4 weeks
- Patients who have received radiotherapy related tp colorectal cancer within 4weeks
- Patients who have participated in other clinical study within the previous 4weeks
- Pregnancy or lactation period
- Human Immunodeficiency Virus antibody (+)
- Have active infection or serious concomitant systemic disorder incompatible with the study
- Clinically hypertension or diabetes mellitus not well controlled with medication
- Clinically significant cardiac disease(congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction
- Presence or history of malignancy other than colorectal cancer within 5years
- Have severe Neurologic or psychological disorder
- Patients who have history of allergy with this investigational drug(SB injection)
- Obvious cognitive or physical impairment that would prevent participation
Sites / Locations
- Inha University HospitalRecruiting
Outcomes
Primary Outcome Measures
Evaluating Tumor Response Rate
Secondary Outcome Measures
Pain Scores on the Visual Analog Scale
evaluate patient's performance by measuring Eastern Cooperative Oncology Group scale
Determine duration of response rate by measuring time to progression
Full Information
NCT ID
NCT01305980
First Posted
February 25, 2011
Last Updated
March 3, 2011
Sponsor
SBPharmaceutical IND, Co., LTD
1. Study Identification
Unique Protocol Identification Number
NCT01305980
Brief Title
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Colorectal Cancer
Official Title
Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
March 2012 (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 Colorectal 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
Colorectal 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
30 (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
evaluate 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 metastatic 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 >/= 1.0 x 10^9/L, Platelet count >/= 75 x 10^9/L
Total bilirubin < 2.0 mg/dL
Aspartate Aminotransferase and/or Aspartate Aminotransferase < 5 x Upper Limit Normal
creatinine < 2 x Upper Limit Normal
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:
Have inflammatory bowel diseases
Have severe diarrhea or ileus
Previous total colectomy
Have ileostomy
Known brain or spinal cord metastases
Patients who have received chemotherapy within the previous 4 weeks
Patients who have received radiotherapy related tp colorectal cancer within 4weeks
Patients who have participated in other clinical study within the previous 4weeks
Pregnancy or lactation period
Human Immunodeficiency Virus antibody (+)
Have active infection or serious concomitant systemic disorder incompatible with the study
Clinically hypertension or diabetes mellitus not well controlled with medication
Clinically significant cardiac disease(congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction
Presence or history of malignancy other than colorectal cancer within 5years
Have severe Neurologic or psychological disorder
Patients who have history of allergy 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
Individual Site Status
Recruiting
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 Colorectal Cancer
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