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Bioequivalence ANDA SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms
Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Summary
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.
Official title: Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer.
Key Details
Gender
All
Age Range
22 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2026-03-18
Completion Date
2026-12-28
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Alectinib - Usual
Usual Alectinib Chemotherapy (NDC...01) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
Alectinib - Study
Study Alectinib Chemotherapy (NDC...86) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
Locations (1)
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
Rockville, Maryland, United States