Pharmacogénomique Étude clinique IND EXEMPT SNP - Polymorphismes de l'alectinib et d'un seul nucléotide (Drugs-SNPs)
Explorez la relation entre les polymorphismes mononucléotidiques et la réponse et la toxicité de l'alectinib chez les patients atteints d'un cancer du poumon non à petites cellules.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Lieux d'étude
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Florida
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Doral, Florida, États-Unis, 33172
- Omnicure Clinical Research
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Maryland
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Rockville, Maryland, États-Unis, 20853
- Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: ALECENSA - alectinib hydrochloride capsule
|
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated
Délai: 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
Délai: Up to 12 weeks
|
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Up to 12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
- Directeur d'études: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
- Chercheur principal: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
- Chercheur principal: Anneyd Avalos, M.D., Omnicure Clinical Research - Site 1
- Chercheur principal: Felipe Gascon-Rondon, M.D., Omnicure Clinical Research - Site 2
- Chercheur principal: Jeffrey Levy, M.D., Omnicure Clinical Research - Site 3
- Chercheur principal: Ellie Soheili, M.D., Omnicure Clinical Research - Site 4
- Chercheur principal: Marc E. Csete, M.D., Omnicure Clinical Research - Site 5
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IND 168453 SNP
- FWA00015357 (Identificateur de registre: HHS, Human Protections Administrator)
- IORG0007849 (Identificateur de registre: HHS, IORG)
- IRB00009424 (Identificateur de registre: HHS, IRB)
- NPI - 1831468511 (Identificateur de registre: HHS, Health Care Provider Individual)
- NPI - 1023387701 (Identificateur de registre: HHS, Health Care Provider Organization)
- IND 168453 (Identificateur de registre: FDA, IND)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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