Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Colorectal Cancer
NCT ID: NCT01305980
Last Updated: 2011-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2010-12-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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SB injection
Infusion SBinjection of 21.87ml/m\^2, IV route, 24times for 4 months
Eligibility Criteria
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Inclusion Criteria
* 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
1. Absolute neutrophil count \>/= 1.0 x 10\^9/L, Platelet count \>/= 75 x 10\^9/L
2. Total bilirubin \< 2.0 mg/dL
3. Aspartate Aminotransferase and/or Aspartate Aminotransferase \< 5 x Upper Limit Normal
4. 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 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
18 Years
ALL
No
Sponsors
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SBPharmaceutical IND, Co., LTD
INDUSTRY
Responsible Party
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SBPharmaceutical IND, Co., LTD
Principal Investigators
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Yong-oon Shin, Prof
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Locations
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Inha University Hospital
Incheon, Jung-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Other Identifiers
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SB injection-C002
Identifier Type: -
Identifier Source: org_study_id
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