Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-25 @ 9:03 PM
Study NCT ID:
NCT05987956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-06
First Post:
2023-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacogenomics IND EXEMPT SNP Clinical Study - Alectinib and Single Nucleotide Polymorphisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-27', 'size': 667931, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_013.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-09T11:56', 'hasProtocol': True}, {'date': '2023-12-27', 'size': 685616, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_014.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-09T11:59', 'hasProtocol': False}, {'date': '2023-12-27', 'size': 929464, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_015.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-09T12:01', '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 (NDC...01)\n* The study approach group (NDC...86)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2023-07-29', 'studyFirstSubmitQcDate': '2023-08-04', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.", 'timeFrame': 'Up to 12 weeks', 'description': '* Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy NDC...01 on ALECENSA - alectinib 600 mg orally twice daily, after biopsy diagnosis, to be the usual approach group.\n* Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy NDC...86 on ALECENSA - alectinib 600 mg orally twice daily, after biopsy diagnosis, to be the study approach group.\n* Measure above every NSCLC patient-specific Alectinib drug target (ALK) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.\n* Report every NSCLC patient-specific ALK SNP genotype in whole genome DNA sequence.\n* Measure above every NSCLC patient-specific Alectinib drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.\n* Report every NSCLC patient-specific CYP4503A4 SNP genotype in whole genome DNA sequence.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALK', 'EGFR', 'NSCLC', 'SNP', 'Pharmacogenomics', 'Gene', 'Genetics'], 'conditions': ['Non-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 ALK gene single nucleotide polymorphisms and ALECENSA - Alectinib therapeutic-effects in patients with non-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 ALECENSA - Alectinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.", 'detailedDescription': "The usual approach group, after biopsy diagnosis, 300 double blind random group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, it will try to look for the relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Alectinib therapeutic safety and the CYP4503A SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.\n\nThe study approach group, after biopsy diagnosis, 300 double blind random group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, it will try to look for the relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Alectinib 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 NSCLC patients.\n2. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind NSCLC patients.\n3. Calculate drug target gene SNPs in all 600 recruited double blind NSCLC 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 NSCLC patients) with the study approach group SNPs (300 double blind random group separated NSCLC 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', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Select 600 Non-Small Cell Lung Cancer Patients who are suitable for blood-drawing.\n* Dosage Duration at least 90 days\n* The usual approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Chemotherapy NDC...01 on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, film coated after biopsy diagnosis, like as the usual approach group.\n* The study approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Chemotherapy NDC...86 on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, film coated after biopsy diagnosis, like as the study approach group.\n\nInclusion Criteria:\n\n* 1\\. Clinical diagnosis of Non-Small Cell Lung Cancer (NSCLC)\n* 2\\. Clinical biopsy diagnosis of NSCLC\n* 3\\. Suitable for enough blood-drawing\n* 4\\. Random and double blind\n* 5\\. Measurable disease\n* 6\\. Adequate organ functions\n* 7\\. Adequate performance status\n* 8\\. Age 22 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\\. Serious 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': 'NCT05987956', 'acronym': 'Drugs-SNPs', 'briefTitle': 'Pharmacogenomics IND EXEMPT SNP Clinical Study - Alectinib and Single Nucleotide Polymorphisms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicine Invention Design, Inc'}, 'officialTitle': 'Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer.', 'orgStudyIdInfo': {'id': 'IND 168453'}, '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 168453', 'type': 'REGISTRY', 'domain': 'FDA, IND'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alectinib - Usual', 'description': '* Usual ALECENSA - Alectinib\n* Chemotherapy (NDC...01)\n* Usual ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily\n* Usual Approach Group (NDC...01)\n* ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily', 'interventionNames': ['Drug: Alectinib - Usual']}, {'type': 'EXPERIMENTAL', 'label': 'Alectinib - Study', 'description': '* Study ALECENSA - Alectinib\n* Chemotherapy (NDC...86)\n* Study ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily\n* Study Approach Group (NDC...86)\n* ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily', 'interventionNames': ['Drug: Alectinib - Study']}], 'interventions': [{'name': 'Alectinib - Usual', 'type': 'DRUG', 'otherNames': ['Usual ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily'], 'description': 'Usual Alectinib Chemotherapy (NDC...01)\n\n\\- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily', 'armGroupLabels': ['Alectinib - Usual']}, {'name': 'Alectinib - Study', 'type': 'DRUG', 'otherNames': ['Study ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily'], 'description': 'Study Alectinib Chemotherapy (NDC...86)\n\n\\- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily', 'armGroupLabels': ['Alectinib - Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20853', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'contacts': [{'name': 'Han Xu, MD/PhD/FAPCR', 'role': 'CONTACT', 'email': 'hanxumd@gmail.com', 'phone': '301-222-7143'}, {'name': 'HAN XU, MD/PhD/FAPCR', 'role': 'CONTACT', 'email': 'midinc@hotmail.com', 'phone': '301-326-8978'}, {'name': 'Han Xu, MD/PhD/FAPCR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medicine Invention Design, Inc. - IORG0007849', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}], 'centralContacts': [{'name': 'Han Xu, MD/PhD/FAPCR', 'role': 'CONTACT', 'email': 'hanxumd@gmail.com', 'phone': '301-222-7143'}, {'name': 'Han Xu, MD/PhD/FAPCR', 'role': 'CONTACT', 'email': 'hanxumd@hotmail.com', 'phone': '301-326-8978'}], 'overallOfficials': [{'name': 'Han Xu, MD/PhD/FAPCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medicine Invention Design, Inc. - IORG0007849'}, {'name': 'Han Xu, MD/PhD/FAPCR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medicine Invention Design, Inc. - IORG0007849'}, {'name': 'Han Xu, MD/PhD/FAPCR', 'role': 'STUDY_CHAIR', 'affiliation': 'Medicine Invention Design, Inc. - IORG0007849'}]}, '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'}}}}