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drugset / Trial / NCT03348670

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

NCT03348670 ↗

Phase 2/3 Active not recruiting 600 enrolled Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
RandomizedParallel-groupQuadruple-blindHealth-services research

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.

Timeline

Start
2023-08-18
Primary completion
2026-11-18
Completion
2026-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule — Oral
Background Bicalutamide Other / unclassified — Oral
Background Prednisone Other / unclassified — Oral

Indications

prostate cancer