Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04803318
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2021-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trametinib Combined With Everolimus and Lenvatinib for Recurrent/Refractory Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'C531958', 'term': 'lenvatinib'}, {'id': 'D000096482', 'term': 'Angiogenesis'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'To treat recurrent or refractory advanced solid tumors with multiple targeting drugs that inhibit several critical signaling pathways in cancer cells.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2037-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-22', 'studyFirstSubmitDate': '2021-03-15', 'studyFirstSubmitQcDate': '2021-03-15', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing Incidence of Treatment-Emergent Adverse Events during the treatment and various responses to the treatment.', 'timeFrame': 'up to 36 months'}], 'secondaryOutcomes': [{'measure': 'Assessing progress free survival', 'timeFrame': '48 months'}, {'measure': 'Assessing overall survival', 'timeFrame': '48 months', 'description': 'Assessing overall time to survival.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma;Lung Cancer', 'Trametinib', 'Everolimus', 'Lenvatinib'], 'conditions': ['Solid Tumor, Adult', 'Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'To study the clinical effect of Trametinib combined with Everolimus and Lenvatinib in the treatment of Recurrent/Refractory advanced solid tumors.', 'detailedDescription': 'The tumor diameter was measured and the efficacy was evaluated after treatment with Trametinib combined with Everolimus and Lenvatinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent/Refractory advanced solid tumors\n* Age between 18 and 85 years\n* Expected life expectancy is greater than three months\n\nExclusion Criteria:\n\n* Benign tumor\n* Life expectancy is less than three months\n* Serious medical commodities\n* others'}, 'identificationModule': {'nctId': 'NCT04803318', 'briefTitle': 'Trametinib Combined With Everolimus and Lenvatinib for Recurrent/Refractory Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Trametinib Combined With Everolimus and Lenvatinib in the Treatment of Recurrent/Refractory Advanced Solid Tumors: a Phase II Clinical Trial', 'orgStudyIdInfo': {'id': 'ZZ3TKI-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination treatment of 3 inhibitors', 'description': 'Oral administration of 3 signaling pathways inhibitors: Mek inhibitor Trametinib, mTOR inhibitor Everolimus, and angiogenesis inhibitor Lenvatinib on refractory advanced solid tumors.', 'interventionNames': ['Drug: Combination of three inhibitors Trametinib, Everolimus and Lenvatinib']}], 'interventions': [{'name': 'Combination of three inhibitors Trametinib, Everolimus and Lenvatinib', 'type': 'DRUG', 'otherNames': ['Combination of 3 signaling pathway inhibitors specific to MEK, mTOR, and angiogenesis.'], 'description': 'Oral administration of three inhibitors including Trametinib, Everolimus and Lenvatinib.', 'armGroupLabels': ['Combination treatment of 3 inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510260', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenfeng Zhang, MD,PhD', 'role': 'CONTACT', 'email': 'zhangzhf@gzhmu.edu.cn', 'phone': '+86-020-39195966'}, {'name': 'Bingjia He, MD', 'role': 'CONTACT', 'email': '464677938@qq.com', 'phone': '+86-14748877800'}], 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zhenfeng Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'zhangzhf@gzhmu.edu.cn', 'phone': '+862039195966'}, {'name': 'Bingjia He, MD', 'role': 'CONTACT', 'email': 'zhangzhf@gzhmu.edu.cn', 'phone': '+862039195966'}], 'overallOfficials': [{'name': 'Zhenfeng Zhang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Guangzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}