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

NCT03348670 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-08-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Abiraterone - Usual

* Oral * Abiraterone Combined Chemotherapy

DRUG

Abiraterone - Study

* Oral * Abiraterone Combined Chemotherapy

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • HAN XU, MD/PhD/FAPCR · Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

  • HAN XU, MD/PhD/FAPCR · Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

  • HAN XU, MD/PhD/FAPCR · Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-18
Primary Completion
2026-05-18
Completion
2026-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03348670 on ClinicalTrials.gov