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

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ClinicalTrials.gov Identifier: NCT01305980
Recruitment Status : Unknown
Verified March 2011 by SBPharmaceutical IND, Co., LTD.
Recruitment status was:  Recruiting
First Posted : March 1, 2011
Last Update Posted : March 4, 2011
Information provided by:
SBPharmaceutical IND, Co., LTD

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: SB injection Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: SB injection
    Infusion SBinjection of 21.87ml/m^2, IV route, 24times for 4 months

Primary Outcome Measures :
  1. Evaluating Tumor Response Rate [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Pain Scores on the Visual Analog Scale [ Time Frame: 4 months ]
  2. evaluate patient's performance by measuring Eastern Cooperative Oncology Group scale [ Time Frame: 4 months ]
  3. Determine duration of response rate by measuring time to progression [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305980

Contact: Yong-oon Shin, Prof. 032-890-2548 ywshin@inha.ac.kr
Contact: Ji-yeon Lee, RN/BSc 032-890-1133 twindleclara@inha.com

Korea, Republic of
Inha University Hospital Recruiting
Incheon, Jung-gu, Korea, Republic of, 400-711
Contact: Yong-oon Shin, Prof.    032-890-2548    ywshin@inha.ac.kr   
Contact: Ji-yeon Lee, RN/BSc    032-890-1133    twinkleclara@inha.com   
Sponsors and Collaborators
SBPharmaceutical IND, Co., LTD
Principal Investigator: Yong-oon Shin, Prof Inha University Hospital

Additional Information:
SBP  This link exits the ClinicalTrials.gov site

Responsible Party: Lee Dong-heum / executive director, SBPharmaceutical IND, Co., LTD
ClinicalTrials.gov Identifier: NCT01305980     History of Changes
Other Study ID Numbers: SB injection-C002
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: March 4, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases