Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-27 @ 3:11 AM
Study NCT ID:
NCT01305993
Status:
UNKNOWN
Last Update Posted:
2011-03-01
First Post:
2011-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'lastUpdateSubmitDate': '2011-02-27', 'studyFirstSubmitDate': '2011-02-25', 'studyFirstSubmitQcDate': '2011-02-27', 'lastUpdatePostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluating Tumor Response Rate', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Pain Scores on the Visual Analog Scale', 'timeFrame': '4 months'}, {'measure': "Evalute patient's performance by measuring Eastern Cooperative Oncology Group scale", 'timeFrame': '4 months'}, {'measure': 'Determine duration of response rate by measuring time to progression', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sbp.com/', 'label': 'SBP'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine efficacy of SB injection in Gastric Cancer.', 'detailedDescription': 'All eligible patients will receive SB injection therapy for 6 cycles (14\\~21 days for each cycle). Efficacy will be evaluated every 3 cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18years or over\n* Patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage and with measurable lesions\n* Life expectancy \\>/= 5 months\n* Not available to any of resectable surgery or radiotherapy\n* Patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by\n\n 1. Absolute neutrophil count(ANC)\\>/= 1.0 x 10\\^9/L, Platelet count \\>/= 75 x 10\\^9/L\n 2. Total bilirubin \\< 2.0mg/dL\n 3. Aspartate Aminotransferase(AST) and/or Alanine Aminotransferase(ALT) \\< 5 x Upper Limit Normal(ULN)\n 4. creatinine \\< 2 x ULN\n* ECOG status 0 to 2\n* 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\n* Patients or their legal representatives who have signed the informed consent form.\n\nExclusion Criteria:\n\n* Known brain or spinal cord metastases\n* Patients who have received chemotherapy within the previous 4 weeks\n* Patients who have received radiotherapy related tp Gastric cancer within 4weeks\n* Patients who have participated in other clinical study within the previous 4weeks\n* Pregnancy (absence to be confirmed by ß-hCG test) or lactation period\n* Human immunodeficiency virus(HIV) antibody (+)\n* Have active infection or serious concomitant systemic disorder incompatible with the study\n* Clinically hypertension or diabete mellitus not well controlled with medication\n* Clinically significant cardiac disease(e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction\n* Presence or history of malignancy other than Gastirc cancer within 5years\n* Have severe Neurologic or psychological disorder\n* Patients who have history of allery with this investigational drug(SB injection)\n* Obvious cognitive or physical impairment that would prevent participation'}, 'identificationModule': {'nctId': 'NCT01305993', 'briefTitle': 'Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'SBPharmaceutical IND, Co., LTD'}, 'officialTitle': 'Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Gastirc Cancer', 'orgStudyIdInfo': {'id': 'SB injection-G002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SB injection', 'type': 'DRUG', 'description': 'Infusion SBinjection of 21.87ml/m\\^2, IV route, 24times for 4 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400-711', 'city': 'Incheon', 'state': 'Jung-gu', 'country': 'South Korea', 'contacts': [{'name': 'Yong-oon Shin, Prof.', 'role': 'CONTACT', 'email': 'ywshin@inha.ac.kr', 'phone': '032-890-2548'}, {'name': 'Ji-yeon Lee, RN/BSc', 'role': 'CONTACT', 'email': 'twinkleclara@inha.com', 'phone': '032-890-1133'}], 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Yong-oon Shin, Prof.', 'role': 'CONTACT', 'email': 'ywshin@inha.ac.kr', 'phone': '032-890-2548'}, {'name': 'Ji-yeon Lee, RN/BSc', 'role': 'CONTACT', 'email': 'twindleclara@inha.com', 'phone': '032-890-1133'}], 'overallOfficials': [{'name': 'Yong-oon Shin, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inha University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SBPharmaceutical IND, Co., LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Lee Dong-heum / executive director', 'oldOrganization': 'SBPharmaceutical IND, Co., LTD'}}}}