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Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

Active Not RecruitingPhase 2, Phase 3

Sponsor: Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair

Conditions: ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

Interventions: Alectinib

Countries: United States

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 overview

Sex: ALL

Age: 24 Years to 64 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

* 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 - 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 Sequential Assignment 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:

* 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

Locations (2)

Doral, Florida, United States
Rockville, Maryland, United States