Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-29 @ 5:54 PM
Study NCT ID:
NCT01924195
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2013-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009369', 'term': 'Neoplasms'}], '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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625192', 'term': 'anlotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-27', 'studyFirstSubmitDate': '2013-08-12', 'studyFirstSubmitQcDate': '2013-08-14', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'enhanced CT/MRI scan', 'timeFrame': 'each 42 days up to disease progression', 'description': 'To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Refer to recist 1.1.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'each 21 days up to intolerance the toxicity(or PD)', 'description': 'contain Serious Adverse Event To evaluate the safety of Anlotinib by CTC AE 4.0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lung', 'Anlotinib', 'AL3818', 'NSCLC', 'Cancer'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of andvanced non-small cell lung cancer who failed two lines of chemotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pathology diagnosed with advanced NSCL with measurable lesions;\n2. Have failed for 2 lines of chemotherapy;\n3. 18-70years,ECOG PS:0-2,Life expectancy of more than 3 months;\n4. Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks;\n5. main organs function is normal;\n6. must be agreed to take contraceptive measures during the study and within 6 months after end.\n\nExclusion Criteria:\n\n1. SCLC(including mixed with NSCLC);\n2. the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;\n3. patients failed to use the anti-tumor angiogenesis therapy;\n4. patients has many influence factors toward oral medications ;\n5. Brain metastases patients accompanied by symptoms or symptom control for less than two months;\n6. patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)\\>10mmol/L);urine protein≥++,etc.\n7. patients failed to heal wounds or fractures for Long-term;\n8. 4 weeks before enrollment, patients appeared NCI CTC AE grading \\>1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade\\> 2 have other parts of the bleeding; patients has a tendency to bleed (eg active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues;\n9. patients occurred venous thromboembolic events within 6 months;\n10. patients has HIV-positive or organ transplantation;'}, 'identificationModule': {'nctId': 'NCT01924195', 'briefTitle': 'Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) as Third Line Treatment in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）', 'orgStudyIdInfo': {'id': 'ALTN-03-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anlotinib', 'description': 'Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent', 'interventionNames': ['Drug: Anlotinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Capsule', 'description': 'Placebo capsule QD po and it should be continued until disease progression or patients withdrawal of consent', 'interventionNames': ['Drug: Placebo capsule']}], 'interventions': [{'name': 'Anlotinib', 'type': 'DRUG', 'description': 'Anlotinib QD po.', 'armGroupLabels': ['Anlotinib']}, {'name': 'Placebo capsule', 'type': 'DRUG', 'description': 'Placebo QD po.', 'armGroupLabels': ['Placebo Capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '101149', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing chest hospital，capital medical university', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400037', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Xinqiao Hospital, Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Province Tumor Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Suzhou University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Jilin province tumor hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Province Tumor Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Chest hospital affiliated to Shanghai jiaotong university', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital,Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The first affiliated hospital,zhejiang university', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Bao hui Han, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chest hospital affiliated to Shanghai jiaotong university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}