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Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms
Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Summary
The usual approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes. The study approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
Official title: Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer.
Key Details
Gender
MALE
Age Range
22 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2023-08-18
Completion Date
2026-05-28
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
Abiraterone - Usual
* Oral * Abiraterone Combined Chemotherapy
Abiraterone - Study
* Oral * Abiraterone Combined Chemotherapy
Locations (1)
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
Rockville, Maryland, United States