Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-29 @ 10:42 AM
Study NCT ID:
NCT04073550
Status:
UNKNOWN
Last Update Posted:
2019-08-29
First Post:
2019-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Anlotinib Hydrochloride Capsule in Subjects With Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625192', 'term': 'anlotinib'}, {'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-27', 'studyFirstSubmitDate': '2019-08-27', 'studyFirstSubmitQcDate': '2019-08-27', 'lastUpdatePostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) evaluated by IRC', 'timeFrame': 'up to 24 months', 'description': 'PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS) evaluated by investigator', 'timeFrame': 'up to 24 months', 'description': 'PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to 24 months', 'description': 'OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'up to 24 months', 'description': 'Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'up to 24 months', 'description': 'Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).'}, {'measure': 'Duration of Overall Response (DOR)', 'timeFrame': 'up to 24 months', 'description': 'The time when the patient first achieved complete or partial remission to disease progression.'}, {'measure': 'PFS rate at month 6', 'timeFrame': 'up to 6 months', 'description': 'The percentage of PFS at month 6.'}, {'measure': 'OS rate at month 6', 'timeFrame': 'up to 6 months', 'description': 'The percentage of OS at month 6.'}, {'measure': 'OS rate at month 12', 'timeFrame': 'up to 12 months', 'description': 'The percentage of OS at month 12.'}, {'measure': 'The efficacy of intracranial lesions', 'timeFrame': 'up to 24 months', 'description': 'To evaluate the efficacy of of intracranial lesions.'}, {'measure': 'Adverse Event (AE)', 'timeFrame': 'up to 24 months', 'description': 'Safety data'}, {'measure': 'Serious Adverse Event (SAE)', 'timeFrame': 'up to 24 months', 'description': 'Safety data'}, {'measure': 'Abnormal laboratory test index', 'timeFrame': 'up to 24 months', 'description': 'Safety data'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Small cell lung cancer patients.\n2. The clinical stage at baseline is extensive.\n3. A measurable lesion.\n4. Disease progression.\n5. ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.\n6. Adequate laboratory indicators.\n7. No pregnant or breastfeeding women, and a negative pregnancy test.\n8. Understood and signed an informed consent form.\n\nExclusion Criteria:\n\n1. Has used topotecan and anlotinib hydrochloride capsules.\n2. Has used other anti-angiogenic drugs and immunologically targeted drugs.\n3. Has other malignant tumors within 5 years.\n4. Symptomatic brain metastasis.\n5. Has a variety of factors affecting oral medications.\n6. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.\n7. Spinal cord compression.\n8. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.\n9. Adverse events caused by previous treatment did not recover to grade 1.\n10. Has received major surgical treatment within 4 weeks before randomization.\n11. Arteriovenous thrombosis occurred within 6 months.\n12. Has drug abuse history that unable to abstain from or mental disorders.\n13. Has severe or uncontrolled disease.\n14. Participated in other clinical trials within 4 weeks.\n15. Tumor invades the large blood vessels.\n16. Daily hemoptysis ≥2.5 mL within 1 month before the first dose.\n17. According to the investigators' judgement."}, 'identificationModule': {'nctId': 'NCT04073550', 'briefTitle': 'Study of Anlotinib Hydrochloride Capsule in Subjects With Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-Blind, Multicenter, Phase Ⅲ Study of Anlotinib Hydrochloride Capsule Combined With Topotecan Versus Placebo Combined With Topotecan in Subjects With Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'ALTN-12-III-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and topotecan 1.5mg/m2 IV d1-5.', 'interventionNames': ['Drug: Anlotinib', 'Drug: Topotecan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and topotecan 1.5mg/m2 IV d1-5.', 'interventionNames': ['Drug: Placebos', 'Drug: Topotecan']}], 'interventions': [{'name': 'Anlotinib', 'type': 'DRUG', 'description': 'A multi-target receptor tyrosine kinase inhibitor.', 'armGroupLabels': ['Experimental group']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Anlotinib blank analog capsule.', 'armGroupLabels': ['Placebo group']}, {'name': 'Topotecan', 'type': 'DRUG', 'description': 'A topoisomerase I inhibitor.', 'armGroupLabels': ['Experimental group', 'Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100083', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Ziping Wang, Doctor', 'role': 'CONTACT', 'email': 'wangzp2007@126.com', 'phone': '010-88196456'}, {'name': 'Ziping Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100083', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Yuankai Shi, Master', 'role': 'CONTACT', 'email': 'syuankaipumc@126.com', 'phone': '010-87788293'}, {'name': 'Yuankai Shi, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'YuanKai Shi, Master', 'role': 'CONTACT', 'email': 'syuankaipumc@126.com', 'phone': '010-87788293'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}