NCT01305993UnknownPhase 2
Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Gastirc Cancer
SBPharmaceutical IND, Co., LTD1 site in 1 country26 target enrollmentStarted: May 1, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Evaluating Tumor Response Rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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 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
- •Absolute neutrophil count(ANC)>/= 1.0 x 10^9/L, Platelet count >/= 75 x 10^9/L
- •Total bilirubin < 2.0mg/dL
- •Aspartate Aminotransferase(AST) and/or Alanine Aminotransferase(ALT) < 5 x Upper Limit Normal(ULN)
- •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
Outcomes
Primary Outcomes
Evaluating Tumor Response Rate
Time Frame: 4 months
Secondary Outcomes
- Pain Scores on the Visual Analog Scale(4 months)
- Evalute patient's performance by measuring Eastern Cooperative Oncology Group scale(4 months)
- Determine duration of response rate by measuring time to progression(4 months)
Investigators
Study Sites (1)
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