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Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Colorectal Cancer

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Colorectal Cancer

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

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

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

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluating Tumor Response Rate

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Yong-oon Shin, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Inha University Hospital


Korea: Food and Drug Administration

Study ID:

SB injection-C002



Start Date:

December 2010

Completion Date:

March 2012

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms