Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2026-01-02 @ 3:30 PM
Study NCT ID:
NCT01305967
Status:
UNKNOWN
Last Update Posted:
2011-03-01
First Post:
2011-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-27', 'studyFirstSubmitDate': '2011-02-24', 'studyFirstSubmitQcDate': '2011-02-27', 'lastUpdatePostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Best Response Rate', 'timeFrame': '2.5 months'}], 'secondaryOutcomes': [{'measure': 'Determine duration of response rate by measuring time to progression', 'timeFrame': '2.5 months'}, {'measure': 'Pain Scores on the Visual Analog Scale', 'timeFrame': '2.5months'}, {'measure': "Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale", 'timeFrame': '2.5months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung 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 Non Small Cell Lung Cancer.', 'detailedDescription': "All eligible patients will receive SB injection therapy for 4 cycles (14\\~21 days for each cycle). SB injection treatment could be continue after completion of therapy cycles until 6th cycle. It depends on the investigator's decision and patient's will. Efficacy will be evaluated every two cycles."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18-70 years\n* Patients with histologically or cytologically confirmed Non-Small Cell Lung Cancer\n* Patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage not available to any of resectable surgery or radiotherapy.\n* Patients with measurable lesions\n* Eatern Cooperative Oncolgy Group status 0 to 2.\n* Life expectancy \\>/= 5 months\n* Patients with adequate organ(heart, kidney, liver)and bone marrow function, as defined by\n\n 1. Absolute neutrophil count \\>/= 1.5 x 10\\^9/L, Platelet count \\>/= 100 x 10\\^9/L\n 2. Total bilirubin \\</= upper limit of normal\n 3. Aspartate Aminotransferase and/or Alanine Aminotransferase \\</= 2 x upeer limit of normal\n 4. creatinine \\</= 1.5 x upeer limit of normal\n* Patients who have signed the informed consent form.\n\nExclusion Criteria:\n\n* Female volunteers admitted to the study must be using a reliable means of contraception\n* Received radiation therapy within 6 weeks before randomization\n* Known brain or spinal cord metastases\n* Have acute infection\n* Have active infection or serious concomitant systemic disorder incompatible with the study\n* Presence or history of malignancy other than Non-Small Cell Lung Cancer\n* Have severe neurologic or psychological disorder\n* Patients who have to receive other chemo-radiotherapy or immunotherapy\n* Patients who have received chemotherapy within the previous 30 days\n* Patients who are candidates for combined modality treatment.\n* Patients who have participated in a clinical study within the previous 30 days'}, 'identificationModule': {'nctId': 'NCT01305967', 'briefTitle': 'Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'SBPharmaceutical IND, Co., LTD'}, 'officialTitle': 'Phase Ⅱa,Open Label,Multicenter Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'SB Injection'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SB injection', 'type': 'DRUG', 'description': 'Infusion SBinjection of 21.87ml/m\\^2, Intravenous route, 16times for 2.5 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '700-712', 'city': 'Daegu', 'state': 'Jung-gu', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '700-721', 'city': 'Deagu', 'state': 'Jung-gu', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': 'Kyungpook University Hospital'}, {'zip': '430-733', 'city': 'Anyang', 'state': 'Man-an-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Cae-young Lee, MD', 'role': 'CONTACT', 'email': 'joy@bovie.org', 'phone': '031-467-9188'}], 'facility': 'Sam Anyang Medical Center', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}], 'centralContacts': [{'name': 'Chae-young Lee, Medical Doctor', 'role': 'CONTACT', 'email': 'joy@bovie.org', 'phone': '031-467-9188'}, {'name': 'A-young Shin, Registered Nurse', 'role': 'CONTACT', 'email': 'gmmi127@nate.com', 'phone': '031-467-9767'}], 'overallOfficials': [{'name': 'Jae-yong Park, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook University Hospital'}, {'name': 'Seung-beom Han, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keimyung University Dongsan Medical Center'}, {'name': 'Chae-young Lee, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anyang Sam Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SBPharmaceutical IND, Co., LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Lee Dong-heum / executive director', 'oldOrganization': 'SBPharmaceutical IND, Co., LTD'}}}}