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

• Status: Unknown status
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine efficacy of SB injection in Colorectal Cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SBPharmaceutical IND, Co., LTD

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

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 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