Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-01-07 @ 6:40 AM
Study NCT ID:
NCT02652234
Status:
UNKNOWN
Last Update Posted:
2016-01-11
First Post:
2016-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Endostar Subcutaneous Injection in NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522911', 'term': 'endostar protein'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-08', 'studyFirstSubmitDate': '2016-01-06', 'studyFirstSubmitQcDate': '2016-01-08', 'lastUpdatePostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of adverse events', 'timeFrame': 'until 30 days after the last dose'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks'}, {'measure': 'AUC', 'timeFrame': 'day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks'}, {'measure': 'Tmax', 'timeFrame': 'day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks'}, {'measure': 'T1/2', 'timeFrame': 'day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks'}, {'measure': 'CL', 'timeFrame': 'day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['NSCLC']}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-arm study to assess the safety, tolerability and pharmacokinetics of Endostar subcutaneous injection in Chinese advanced NSCLC patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histological/cytological confirmed unresectable stage ⅢB～Ⅳ non-squamous NSCLC\n* ECOG performance status 0-1\n* Life expectancy≥3 months\n* Adequate hematologic function: WBC≥3.0×109/L ,ANC≥1.5×10\\^9/L, Hb≥90g/L, PLT≥100×10\\^9/L;\n* Adequate hepatic and renal function: ALT≤2.5×ULN, AST≤2.5×ULN, TBIL≤1.5×ULN, creatinine≤1×ULN, creatinine clearance≥50ml/min;\n* Normal coagulation function (PT, APTT, TT, Fbg) ;\n* Patients signed informed consent form;\n* Willingness and capability to comply with protocol requirement and well communicate with investigators.\n\nExclusion Criteria:\n\n* With uncontrolled ascites or pleural effusion;\n* Patients receiving a chest or abdominal surgery within 28 days before enrollment; or with not fully healed surgical incision; or expected to receive surgery during the study;\n* History of ischemic or TIA within 6 months before enrollment;\n* Uncontrolled hypertension, hypertensive crisis or hypertensive encephalopathy;\n* Arrhythmias need to be treated; history of coronary artery disease (including angina pectoris and myocardial infarction) or ischemic myocardium; congestive heart-failure NYHA class ≥ II；\n* Serious active infections;\n* History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment;\n* Symptomatic brain or meningeal metastasis;\n* Epileptic seizure need to be treated;\n* HCV, HBV or HIV positive;\n* History of other malignant tumors within 5 years (except curable cervix carcinoma in situ or skin basal cell carcinoma);\n* Known allergies to any excipient in the study drug;\n* Any conditions that may interfere with the patient's participation in the study or have an impact on the assessment of the results of the study;\n* Any conditions that may endanger patient safety or interfere with the patient's compliance;\n* Pregnant and lactating women;\n* The investigators consider the patients unsuitable for this trial"}, 'identificationModule': {'nctId': 'NCT02652234', 'briefTitle': 'Study of Endostar Subcutaneous Injection in NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Simcere Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Single-arm, Open-label Study to Investigate the Safety, Tolerability and Pharmacokinetics of Endostar Subcutaneous Injection in Chinese Advanced NSCLC Patients', 'orgStudyIdInfo': {'id': 'SIM-ED-201504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endostar-subcutaneous injection/Chemotherapy', 'interventionNames': ['Drug: Endostar', 'Drug: Chemotherapy']}], 'interventions': [{'name': 'Endostar', 'type': 'DRUG', 'description': 'Endostar, ih, QD，day 1 of cycle 1; Endostar, ih, QD，day 2-15 of cycle 3;', 'armGroupLabels': ['Endostar-subcutaneous injection/Chemotherapy']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'armGroupLabels': ['Endostar-subcutaneous injection/Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jia Chen', 'role': 'CONTACT'}, {'name': 'Lingxiang Chen', 'role': 'CONTACT'}], 'facility': 'Jiangsu Province Cancer Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Yanhong Zhu', 'role': 'CONTACT', 'phone': '86-025-85560000'}], 'overallOfficials': [{'name': 'Jia Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Province Cancer Hospital'}, {'name': 'Lingxiang Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Province Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Simcere Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}