Farmakogenomik IND EXEMPT SNP klinisk undersøgelse - Alectinib og enkeltnukleotidpolymorfismer (Drugs-SNPs)
Udforsk forholdet mellem enkeltnukleotidpolymorfier og Alectinib-respons og toksicitet hos patienter med ikke-småcellet lungekræft.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiesteder
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Florida
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Doral, Florida, Forenede Stater, 33172
- Omnicure Clinical Research
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Maryland
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Rockville, Maryland, Forenede Stater, 20853
- Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: ALECENSA - alectinib hydrochloride capsule
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Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated
Tidsramme: 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
Tidsramme: Up to 12 weeks
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Up to 12 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
- Studieleder: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
- Ledende efterforsker: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
- Ledende efterforsker: Anneyd Avalos, M.D., Omnicure Clinical Research - Site 1
- Ledende efterforsker: Felipe Gascon-Rondon, M.D., Omnicure Clinical Research - Site 2
- Ledende efterforsker: Jeffrey Levy, M.D., Omnicure Clinical Research - Site 3
- Ledende efterforsker: Ellie Soheili, M.D., Omnicure Clinical Research - Site 4
- Ledende efterforsker: Marc E. Csete, M.D., Omnicure Clinical Research - Site 5
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IND 168453 SNP
- FWA00015357 (Registry Identifier: HHS, Human Protections Administrator)
- IORG0007849 (Registry Identifier: HHS, IORG)
- IRB00009424 (Registry Identifier: HHS, IRB)
- NPI - 1831468511 (Registry Identifier: HHS, Health Care Provider Individual)
- NPI - 1023387701 (Registry Identifier: HHS, Health Care Provider Organization)
- IND 168453 (Registry Identifier: FDA, IND)
Plan for individuelle deltagerdata (IPD)
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