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.
Eligibility
Sex
ALL
Min age
24 Years
Max age
64 Years
Healthy volunteers
No
* 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
* Dosage Duration at least 90 days
* 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.
* 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
Primary outcome measure(s)
Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated — Up to 12 weeks * Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...01 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the usual approach group.
* Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...86 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the study approach group.
* 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.
* Report every NSCLC patient-specific ALK SNP genotype in whole genome DNA sequence.
Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated — Up to 12 weeks * Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...01 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the usual approach group.
* Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...86 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the study approach group.
* Measure above every NSCLC patient-specific Alectinib drug target (CYP3A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
* Report every NSCLC patient-specific CYP3A4 SNP genotype in whole genome DNA sequence.
Trial sites (2)
Facility
City
Region
Status
Omnicure Clinical Research
Doral
Florida
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
Rockville
Maryland
More Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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