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

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

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

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: SB injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yong-oon Shin, Prof.; Phone Number: 032-890-2548; Email: ywshin@inha.ac.kr
• Study Contact Backup: Name: Ji-yeon Lee, RN/BSc; Phone Number: 032-890-1133; Email: twindleclara@inha.com

Study Locations

• Korea, Republic of
  • Jung-gu
    • Incheon, Jung-gu, Korea, Republic of, 400-711
      • Recruiting
      • Inha university hospital
      • Contact: Yong-oon Shin, Prof.; Phone Number: 032-890-2548; Email: ywshin@inha.ac.kr
      • Contact: Ji-yeon Lee, RN/BSc; Phone Number: 032-890-1133; Email: twinkleclara@inha.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluating Tumor Response Rate	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain Scores on the Visual Analog Scale	4 months
Determine duration of response rate by measuring time to progression	4 months
evaluate patient's performance by measuring Eastern Cooperative Oncology Group scale	4 months

Collaborators and Investigators

• Sponsor: SBPharmaceutical IND, Co., LTD
• Investigators: Principal Investigator: Yong-oon Shin, Prof, Inha university hospital

Publications and helpful links

Helpful Links

• SBP

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 27, 2011
• First Posted (Estimate): March 1, 2011

Study Record Updates

• Last Update Posted (Estimate): March 4, 2011
• Last Update Submitted That Met QC Criteria: March 3, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: SB injection-C002