Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-31 @ 6:55 PM
Study NCT ID:
NCT01064466
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-24
First Post:
2010-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'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': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-16', 'size': 585549, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_019.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-18T12:03', 'hasProtocol': True}, {'date': '2025-07-16', 'size': 721314, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_020.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-18T12:04', 'hasProtocol': False}, {'date': '2025-07-16', 'size': 1006923, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_021.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-07-18T12:04', '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': '2025-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2010-02-02', 'studyFirstSubmitQcDate': '2010-02-04', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.", 'timeFrame': 'Duration at least 90 days', 'description': '1. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on Etoposide 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 Etoposide Capsule after lung tissue biopsy, like as the study approach group.\n3. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (Topoisomerase II) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.\n4. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SCLC', 'Etoposide', 'SNP', 'Topo', 'CYP', 'Genotype', 'Oncology', 'Genetics', 'Lung', 'Cancer'], 'conditions': ['Small Cell Lung Cancer']}, '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 II gene single nucleotide polymorphisms and Etoposide (VP-16) 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 Etoposide (VP-16) 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 ETOPOSIDE capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE 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 Etoposide Capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.\n\n* 1\\) Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind SCLC patients.\n* 2\\) Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind SCLC patients.\n* 3\\) Calculate drug target gene SNPs in all 600 recruited double blind SCLC patients.\n* 4\\) Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.\n* 5\\) Correlate everyone patient drug target gene SNP to everyone patient drug safety.\n* 6\\) 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).\n* 7\\) Confirm the relationship between drug target gene SNPs and drug efficacy.\n* 8\\) 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 Etoposide 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 Etoposide Capsule after lung tissue biopsy, like as the study approach group.\n\nThe inclusion 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\nThe exclusion 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': 'NCT01064466', 'acronym': 'Drugs-SNPs', 'briefTitle': 'Pharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicine Invention Design, Inc'}, 'officialTitle': 'Explore the Relationship Between Single Nucleotide Polymorphisms and Etoposide Response and Toxicity in Patients With Small Cell Lung Cancer.', 'orgStudyIdInfo': {'id': 'IND 178172 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': 'IND 178172', 'type': 'REGISTRY', 'domain': 'FDA IND'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ETOPOSIDE - Usual', 'description': '* Etoposide Capsule\n* Chemotherapy\n* Etoposide Capsule\n* Usual Approach Group', 'interventionNames': ['Drug: ETOPOSIDE - Usual']}, {'type': 'EXPERIMENTAL', 'label': 'ETOPOSIDE - Study', 'description': '* China Import Etoposide Capsule\n* Chemotherapy\n* China Import Etoposide Capsule\n* Study Approach Group', 'interventionNames': ['Drug: ETOPOSIDE - Study']}], 'interventions': [{'name': 'ETOPOSIDE - Usual', 'type': 'DRUG', 'otherNames': ['Usual Etoposide Capsule Chemotherapy'], 'description': 'Etoposide Capsule', 'armGroupLabels': ['ETOPOSIDE - Usual']}, {'name': 'ETOPOSIDE - Study', 'type': 'DRUG', 'otherNames': ['Study Etoposide Capsule Chemotherapy'], 'description': 'China Import Etoposide Capsule', 'armGroupLabels': ['ETOPOSIDE - Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20853', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}], 'overallOfficials': [{'name': 'HAN XU, MD/PhD/FAPCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701'}, {'name': 'HAN XU, MD/PhD/FAPCR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701'}, {'name': 'HAN XU, MD/PhD/FAPCR', 'role': 'STUDY_CHAIR', 'affiliation': 'Medicine Invention Design, Inc. (MIDI) - 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., Sponsor-Investigator, Medical Director, Medical Monitor, Safety Officer, IRB Chair', 'investigatorFullName': 'Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair', 'investigatorAffiliation': 'Medicine Invention Design, Inc'}}}}