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

NCT03348670 · tracked via the Priya Life Science USA tracker

Sponsor

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

Phase

Phase 2/3

Started

2023-08-18

Last updated

2026-06-10

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Abiraterone - UsualAbiraterone - Study

Abiraterone - Usual: * Oral * Abiraterone Combined Chemotherapy

Abiraterone - Study: * Oral * Abiraterone Combined Chemotherapy

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.

Eligibility

Sex

MALE

Min age

22 Years

Max age

75 Years

Healthy volunteers

* Select 600 localized Prostate Cancer Patients without prostate resection * Dosage Duration at least 90 days * The usual approach group - Recruit 300 double blind random group separated prostate cancer patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet, like as the usual approach group. * The study approach group - Recruit 300 double blind random group separated prostate cancer patients currently used the Combined Chemotherapy on China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet, like as the study approach group. Inclusion Criteria: 1. Clinical diagnosis of Prostate Cancer (PC) 2. Cancer in the prostate only 3. Prior therapy without orchiectomy 4. Prior therapy without prostate resection 5. Prior different chemotherapy must-need stop 6. Have no other cancer at the same time 7. Sign an informed consent form 8. Receive blood-drawing Exclusion Criteria: 1. Treatment with other anti-cancer therapies and the therapies cannot be stopped currently 2. The patients with other serious intercurrent illness or infectious diseases 3. Have more than one different kind of cancer at the same time 4. Serious Allergy to Drugs 5. Serious Bleed Tendency 6. Serious Risks or Serious Adverse Events of the drug product label 7. Serious Risks or Serious Adverse Events of NCI Table of Side Effects 8. The prohibition of drug products 9. Have no therapeutic effects 10. Follow up to the most current label and plan for safety monitoring

Primary outcome measure(s)

Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. — Up to 12 weeks
* Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy on ZYTIGA - Abiraterone tablet plus Prednisone tablet plus BICALUTAMIDE tablet to be the usual approach group. * Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy on China Import - Abiraterone tablet plus Prednisone tablet plus BICALUTAMIDE tablet to be the study approach group. * Measure above every PC patient specific Abiraterone drug target (CYP17) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every PC patient specific CYP17 SNP genotype in whole genome DNA sequence. * Measure above every PC patient specific Abiraterone drug target (SULT2A1) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every PC patient specific SULT2A1 SNP genotype in whole genome DNA sequence.

Trial sites (1)

Facility	City	Region	Status
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701	Rockville	Maryland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03348670 on ClinicalTrials.gov ↗ ← All trials in the USA