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| ID | Type | Description | Link |
|---|---|---|---|
| FWA00015357 | Registry Identifier | HHS, Human Protections Administrator | |
| NPI - 1831468511 | Registry Identifier | HHS, Health Care Provider Individual | |
| NPI - 1023387701 | Registry Identifier | HHS, Health Care Provider Organization | |
| IRB00009424 | Registry Identifier | HHS, IRB | |
| IORG0007849 | Registry Identifier | HHS, IORG | |
| IND 168453 | Registry Identifier | FDA, IND |
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| Name | Class |
|---|---|
| UnitedHealthcare | OTHER |
| Omnicure Clinical Research | UNKNOWN |
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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.
Explore 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.
The usual approach group, diagnosed metastatic ALK-positive NSCLC, 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.
The study approach group, diagnosed metastatic ALK-positive NSCLC, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alectinib - Usual | Experimental |
|
|
| Alectinib - Study | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alectinib - Usual | Drug | Usual Alectinib Chemotherapy (NDC...01) - ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated |
| Up to 12 weeks |
| Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated |
| Up to 12 weeks |
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Select 600 patients with Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:
Dosage Duration at least 90 days
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 diagnosed metastatic ALK-positive NSCLC, like as the usual approach group.
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 diagnosed metastatic ALK-positive NSCLC, like as the study approach group.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han Xu, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701 | Principal Investigator |
| Han Xu, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701 | Study Director |
| Han Xu, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701 | Study Chair |
| Anneyd Avalos, M.D. | Omnicure Clinical Research - Site 1 | Principal Investigator |
| Felipe Gascon-Rondon, M.D. | Omnicure Clinical Research - Site 2 | Principal Investigator |
| Jeffrey Levy, M.D. | Omnicure Clinical Research - Site 3 | Principal Investigator |
| Ellie Soheili, M.D. | Omnicure Clinical Research - Site 4 | Principal Investigator |
| Marc E. Csete, M.D. | Omnicure Clinical Research - Site 5 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omnicure Clinical Research | Doral | Florida | 33172 | United States | ||
| Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701 |
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| Label | URL |
|---|---|
| FWA \< 00015357 \> \< Medicine Invention Design Incorporation (MIDI) \> | View source |
| IRB \< 00009424 \> \< Medicine Invention Design Incorporation (MIDI) \> | View source |
| IORG \< 0007849 \> \< Medicine Invention Design Incorporation (MIDI) \> |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2026 | Jun 27, 2026 |
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No-placebo and random and double blind
| Alectinib - Study | Drug | Study Alectinib Chemotherapy (NDC...86) - ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily |
|
|
| Rockville |
| Maryland |
| 20853 |
| United States |
| View source |
| Prot_016.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2026 | Jun 27, 2026 | SAP_017.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2026 | Jun 27, 2026 | ICF_018.pdf |