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ACTIVE NOT RECRUITING
NCT03348670
PHASE2/PHASE3

Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms

Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

View on ClinicalTrials.gov

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

DRUG

Abiraterone - Usual

* Oral * Abiraterone Combined Chemotherapy

DRUG

Abiraterone - Study

* Oral * Abiraterone Combined Chemotherapy

Locations (1)

Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

Rockville, Maryland, United States