Farmacogenómica Estudio clínico de SNP EXENTO IND - Alectinib y polimorfismos de nucleótido único (Drugs-SNPs)
Explore la relación entre los polimorfismos de nucleótido único y la respuesta y toxicidad de alectinib en pacientes con cáncer de pulmón de células no pequeñas.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The usual approach group, diagnosed metastatic ALK-positive NSCLC, 300 Sequential Assignment 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 Sequential Assignment 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.
- Detect drug target whole gene precision sequence of everyone patient for all 600 recruited Sequential Assignment NSCLC patients.
- Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited Sequential Assignment NSCLC patients.
- Calculate drug target gene SNPs in all 600 recruited Sequential Assignment NSCLC patients.
- Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
- Correlate everyone patient drug target gene SNP to everyone patient drug safety.
- Mutually compare the usual approach group SNPs (300 Sequential Assignment group separated NSCLC patients) with the study approach group SNPs (300 Sequential Assignment group separated NSCLC patients).
- Confirm the relationship between drug target gene SNPs and drug efficacy.
- Confirm the relationship between drug target gene SNPs and drug safety.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Doral, Florida, Estados Unidos, 33172
- Omnicure Clinical Research
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Maryland
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Rockville, Maryland, Estados Unidos, 20853
- Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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Select 600 patients with Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:
- Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
- Had no further NSCLC metastatic or growth in more than previous 90 days
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Dosage Duration at least 90 days
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The usual approach group - Recruit 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy NDC...01 on ALECENSA capsule 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, like as the usual approach group.
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The study approach group - Recruit 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy NDC...86 on ALECENSA capsule 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, like as the study approach group.
Inclusion Criteria:
- 1. Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:
- Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
- Had no further NSCLC metastatic or growth in more than previous 90 days
- 2. Suitable for enough blood-drawing
- 3. Sequential Assignment
- 4. Measurable disease
- 5. Adequate organ functions
- 6. Adequate performance status
- 7. Age 24-64 years old
- 8. Sign an informed consent form
- 9. Receive blood-drawing
Exclusion Criteria:
- 1. Pneumonectomy
- 2. Treatment with other anti-cancer therapies and cannot be stopped currently
- 3. Pregnancy
- 4. Breast-feeding
- 5. The patients with other serious intercurrent illness or infectious diseases
- 6. Have more than one different kind of cancer at the same time
- 7. Serious Allergy to Drugs
- 8. Serious Bleed Tendency
- 9. Serious Risks or Serious Adverse Events of the drug product
- 10. The prohibition of drug products
- 11. Have no therapeutic effects
- 12. Follow up to the most current label
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ALECENSA - alectinib hydrochloride capsule
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated
Periodo de tiempo: Up to 12 weeks
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Up to 12 weeks
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Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated
Periodo de tiempo: Up to 12 weeks
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Up to 12 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
- Director de estudio: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
- Investigador principal: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
- Investigador principal: Anneyd Avalos, M.D., Omnicure Clinical Research - Site 1
- Investigador principal: Felipe Gascon-Rondon, M.D., Omnicure Clinical Research - Site 2
- Investigador principal: Jeffrey Levy, M.D., Omnicure Clinical Research - Site 3
- Investigador principal: Ellie Soheili, M.D., Omnicure Clinical Research - Site 4
- Investigador principal: Marc E. Csete, M.D., Omnicure Clinical Research - Site 5
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IND 168453 SNP
- FWA00015357 (Identificador de registro: HHS, Human Protections Administrator)
- IORG0007849 (Identificador de registro: HHS, IORG)
- IRB00009424 (Identificador de registro: HHS, IRB)
- NPI - 1831468511 (Identificador de registro: HHS, Health Care Provider Individual)
- NPI - 1023387701 (Identificador de registro: HHS, Health Care Provider Organization)
- IND 168453 (Identificador de registro: FDA, IND)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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