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Trial Title:
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Gastric Cancer
NCT ID:
NCT01305993
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SB injection
Description:
Infusion SBinjection of 21.87ml/m^2, IV route, 24times for 4 months
Summary:
The purpose of this study is to determine efficacy of SB injection in Gastric Cancer.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age of 18years or over
- Patients who had failed more than 1 cycle of standard therapy with advanced or
metasatic 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(ANC)>/= 1.0 x 10^9/L, Platelet count >/= 75 x 10^9/L
2. Total bilirubin < 2.0mg/dL
3. Aspartate Aminotransferase(AST) and/or Alanine Aminotransferase(ALT) < 5 x
Upper Limit Normal(ULN)
4. creatinine < 2 x ULN
- 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:
- Known brain or spinal cord metastases
- Patients who have received chemotherapy within the previous 4 weeks
- Patients who have received radiotherapy related tp Gastric cancer within 4weeks
- Patients who have participated in other clinical study within the previous 4weeks
- Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
- Human immunodeficiency virus(HIV) antibody (+)
- Have active infection or serious concomitant systemic disorder incompatible with the
study
- Clinically hypertension or diabete mellitus not well controlled with medication
- Clinically significant cardiac disease(e.g. congestive heart failure, symptomatic
coronary artery disease and cardiac arrhythmias) or myocardial infarction
- Presence or history of malignancy other than Gastirc cancer within 5years
- Have severe Neurologic or psychological disorder
- Patients who have history of allery with this investigational drug(SB injection)
- Obvious cognitive or physical impairment that would prevent participation
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Inha University Hospital
Address:
City:
Incheon
Zip:
400-711
Country:
Korea, Republic of
Contact:
Last name:
Yong-oon Shin, Prof.
Phone:
032-890-2548
Email:
ywshin@inha.ac.kr
Contact backup:
Last name:
Ji-yeon Lee, RN/BSc
Phone:
032-890-1133
Email:
twinkleclara@inha.com
Start date:
May 2011
Lead sponsor:
Agency:
SBPharmaceutical IND, Co., LTD
Agency class:
Industry
Source:
SBPharmaceutical IND, Co., LTD
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01305993
http://www.sbp.com/
