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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by SBPharmaceutical IND, Co., LTD.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
SBPharmaceutical IND, Co., LTD
ClinicalTrials.gov Identifier:
NCT01305980
First received: February 25, 2011
Last updated: March 3, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Drug: SB injection
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SBPharmaceutical IND, Co., LTD:

Primary Outcome Measures:
  • Evaluating Tumor Response Rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Scores on the Visual Analog Scale [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • evaluate patient's performance by measuring Eastern Cooperative Oncology Group scale [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Determine duration of response rate by measuring time to progression [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB injection
    Infusion SBinjection of 21.87ml/m^2, IV route, 24times for 4 months
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305980

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

Locations
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
Investigators
Principal Investigator: Yong-oon Shin, Prof Inha University Hospital
  More Information

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

No publications provided

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
Study First Received: February 25, 2011
Last Updated: March 3, 2011
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014