Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-07 @ 7:09 AM
Study NCT ID:
NCT07145333
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-08-25', 'size': 588371, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-29T06:48', 'hasProtocol': True}, {'date': '2025-08-25', 'size': 720622, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-29T06:50', 'hasProtocol': False}, {'date': '2025-08-25', 'size': 1002738, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-29T06:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'No-placebo and random and double blind'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* The usual approach group (Oral)\n* The study approach group (Oral) (China Import)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-10-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2025-08-14', 'studyFirstSubmitQcDate': '2025-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Find Topotecan Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.", 'timeFrame': 'Duration up to 14 weeks', 'description': '1. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on Topotecan Capsule after lung tissue biopsy, like as the usual approach group.\n2. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Topotecan Capsule after lung tissue biopsy, like as the study approach group.\n3. Assay above every SCLC patient-specific Topotecan drug target (Topoisomerase I) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.\n4. Assay above every SCLC patient-specific Topotecan drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SNP', 'Topotecan', 'TOPO', 'CYP', 'Genotype'], 'conditions': ['SCLC']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://ohrp.cit.nih.gov/search', 'label': 'FWA \\< 00015357 \\> \\< Medicine Invention Design Incorporation (MIDI) \\>'}, {'url': 'http://ohrp.cit.nih.gov/search', 'label': 'IRB \\< 00009424 \\> \\< Medicine Invention Design Incorporation (MIDI) \\>'}, {'url': 'http://ohrp.cit.nih.gov/search', 'label': 'IORG \\< 0007849 \\> \\< Medicine Invention Design Incorporation (MIDI) \\>'}]}, 'descriptionModule': {'briefSummary': "Explore the relationship between drug target topoisomerase I gene single nucleotide polymorphisms and Topotecan therapeutic-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.\n\nExplore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and Topotecan side-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.", 'detailedDescription': "The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Chemotherapy on Topotecan capsule, it will try to look for the relationship between the Topotecan therapeutic efficacy and the Topoisomerase I SNP Genotyping, and the relationship between the Topotecan therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.\n\nThe study approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Topotecan Capsule, it will try to look for the relationship between the Topotecan therapeutic efficacy and the Topoisomerase I SNP Genotyping, and the relationship between the Topotecan therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.\n\n1. Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind SCLC patients.\n2. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind SCLC patients.\n3. Calculate drug target gene SNPs in all 600 recruited double blind SCLC patients.\n4. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.\n5. Correlate everyone patient drug target gene SNP to everyone patient drug safety.\n6. Mutually compare the usual approach group SNPs (300 double blind random group separated SCLC patients) with the study approach group SNPs (300 double blind random group separated SCLC patients).\n7. Confirm the relationship between drug target gene SNPs and drug efficacy.\n8. Confirm the relationship between drug target gene SNPs and drug safety."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '24 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Select 600 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy\n* Dosage Duration at least 45 days\n* The usual approach group - Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on Topotecan Capsule after lung tissue biopsy, like as the usual approach group.\n* The study approach group - Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Topotecan Capsule after lung tissue biopsy, like as the study approach group.\n\nInclusion Criteria:\n\n* 1\\. Clinical diagnosis of Small Cell Lung Cancer (SCLC)\n* 2\\. Clinical lung tissue biopsy diagnosis of SCLC\n* 3\\. Suitable for enough lung tissue biopsy of SCLC\n* 4\\. Random and double blind\n* 5\\. Measurable disease\n* 6\\. Adequate organ functions\n* 7\\. Adequate performance status\n* 8\\. Age 24 years old and over\n* 9\\. Sign an informed consent form\n* 10\\. Receive blood-drawing\n\nExclusion Criteria:\n\n* 1\\. Pneumonectomy\n* 2\\. Treatment with other anti-cancer therapies and cannot be stopped currently\n* 3\\. Pregnancy\n* 4\\. Breast-feeding\n* 5\\. The patients with other serious intercurrent illness or infectious diseases\n* 6\\. Have more than one different kind of cancer at the same time\n* 7\\. Serious Allergy to Drugs\n* 8\\. Clot or Bleed Tendency\n* 9\\. Serious Risks or Serious Adverse Events of the drug product\n* 10\\. The prohibition of drug products\n* 11\\. Have no therapeutic effects\n* 12\\. Follow up to the most current label'}, 'identificationModule': {'nctId': 'NCT07145333', 'acronym': 'Drug-SNP', 'briefTitle': 'Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicine Invention Design, Inc'}, 'officialTitle': 'Explore the Relationship Between Single Nucleotide Polymorphisms and Topotecan Response and Toxicity in Patients With Small Cell Lung Cancer.', 'orgStudyIdInfo': {'id': 'IND 178174 Commercial'}, 'secondaryIdInfos': [{'id': 'FWA00015357', 'type': 'REGISTRY', 'domain': 'HHS, Human Protections Administrator'}, {'id': 'NPI-1831468511', 'type': 'REGISTRY', 'domain': 'HHS, Health Care Provider Individual'}, {'id': 'NPI-1023387701', 'type': 'REGISTRY', 'domain': 'HHS, Health Care Provider Organization'}, {'id': 'IRB00009424', 'type': 'REGISTRY', 'domain': 'HHS, IRB'}, {'id': 'IORG0007849', 'type': 'REGISTRY', 'domain': 'HHS, IORG'}, {'id': 'IND178174', 'type': 'REGISTRY', 'domain': 'FDA, IND'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topotecan - usual', 'description': '* Topotecan Capsule\n* Chemotherapy\n* Topotecan Capsule\n* Usual Approach Group', 'interventionNames': ['Drug: Topotecan - usual']}, {'type': 'EXPERIMENTAL', 'label': 'Topotecan - study', 'description': '* China Import Topotecan Capsule\n* Chemotherapy\n* China Import Topotecan Capsule\n* Study Approach Group', 'interventionNames': ['Drug: Topotecan - study']}], 'interventions': [{'name': 'Topotecan - usual', 'type': 'DRUG', 'otherNames': ['Usual Topotecan Capsule Chemotherapy'], 'description': 'Topotecan Capsule', 'armGroupLabels': ['Topotecan - usual']}, {'name': 'Topotecan - study', 'type': 'DRUG', 'otherNames': ['Study Topotecan Capsule Chemotherapy'], 'description': 'China Import Topotecan Capsule', 'armGroupLabels': ['Topotecan - study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20853', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Medicine Invention Design Incorporation', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}], 'overallOfficials': [{'name': 'HAN XU, MD/PhD/FAPCR', 'role': 'STUDY_CHAIR', 'affiliation': 'Medicine Invention Design, Inc. - IRB00009424 - IORG0007849'}, {'name': 'HAN XU, MD/PhD/FAPCR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701'}, {'name': 'HAN ID XU, MD/PhD/FAPCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'UnitedHealthcare', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair', 'investigatorFullName': 'Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair', 'investigatorAffiliation': 'Medicine Invention Design, Inc'}}}}