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
Recruitment status was Recruiting
Sponsor:
SBPharmaceutical IND, Co., LTD
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
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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:
Detailed Description:
-
Drug: SB injection
Infusion SBinjection of 21.87ml/m^2, IV route, 24times for 4 months
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
- Absolute neutrophil count >/= 1.0 x 10^9/L, Platelet count >/= 75 x 10^9/L
- Total bilirubin < 2.0 mg/dL
- Aspartate Aminotransferase and/or Aspartate Aminotransferase < 5 x Upper Limit Normal
- 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
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:
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 Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013