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

NCT01305993 | Unknown Phase 2

• 1 other identifier: SB injection-G002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluating Tumor Response Rate

  4 months

Secondary Outcomes (3)

• 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

Interventions

SB injection DRUG

Infusion SBinjection of 21.87ml/m\^2, IV route, 24times for 4 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SBPharmaceutical IND, Co., LTD: lead

Study Sites (1)

Inha University Hospital

Incheon, Jung-gu, 400-711, South Korea

Location

Related Links

• SBP

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Yong-oon Shin, Prof

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-oon Shin, Prof.

CONTACT

032-890-2548; ywshin@inha.ac.kr

Ji-yeon Lee, RN/BSc

CONTACT

032-890-1133; twindleclara@inha.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 1, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Last Updated: March 1, 2011

Record last verified: 2011-02

Locations

KR (1)