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

Phase 2

• Conditions: Gastric Cancer

• Registration Number: NCT01305993
• Lead Sponsor: SBPharmaceutical IND, Co., LTD

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 Timeline

• Status Verified: 2011-02
• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-27
• Last Update Submitted: 2011-02-27
• Study First Posted: 2011-03-01
• Last Update Posted: 2011-03-01
• Study Start: 2011-05
• Primary Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluating Tumor Response Rate	4 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Jung-gu, Korea, Republic of