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

NCT03348670 | Active Not Recruiting Phase 2 DMC FDA Drug

• 7 other identifiers: IND 178620 CommercialFWA00015357IRB00009424IORG0007849NPI - 1831468511NPI - 1023387701IND 178620
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

Prostate Cancer; PC; SNP; Oncology; Genetics; Pharmacogenomics; CYP

Outcome Measures

Primary Outcomes (1)

• Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.

  * 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.

  Up to 12 weeks

Study Arms (2)

Abiraterone - Usual

EXPERIMENTAL

* ZYTIGA - Abiraterone * Combined Chemotherapy * ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet * Usual Approach Group

Drug: Abiraterone - Usual

Abiraterone - Study

EXPERIMENTAL

* China Import - Abiraterone * Combined Chemotherapy * China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet * Usual Approach Group

Drug: Abiraterone - Study

Interventions

Abiraterone - Usual DRUG

* Oral * Abiraterone Combined Chemotherapy

Also known as: ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet for Oral

Abiraterone - Usual

Abiraterone - Study DRUG

* Oral * Abiraterone Combined Chemotherapy

Also known as: China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet for Oral

Abiraterone - Study

Eligibility Criteria

• Age: 22 Years - 75 Years
• Gender Eligibility Details: Prostate is male organ.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Prostate Cancer (PC)
• Cancer in the prostate only
• Prior therapy without orchiectomy
• Prior therapy without prostate resection
• Prior different chemotherapy must-need stop
• Have no other cancer at the same time
• Sign an informed consent form
• Receive blood-drawing

You may not qualify if:

• Treatment with other anti-cancer therapies and the therapies cannot be stopped currently
• The patients with other serious intercurrent illness or infectious diseases
• Have more than one different kind of cancer at the same time
• Serious Allergy to Drugs
• Serious Bleed Tendency
• Serious Risks or Serious Adverse Events of the drug product label
• Serious Risks or Serious Adverse Events of NCI Table of Side Effects
• The prohibition of drug products
• Have no therapeutic effects
• Follow up to the most current label and plan for safety monitoring

Sponsors & Collaborators

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

Study Sites (1)

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

Rockville, Maryland, 20853, United States

Location

Related Links

• FWA00015357
• IRB00009424
• IORG0007849

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Prednisone; bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• HAN XU, MD/PhD/FAPCR

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

  STUDY CHAIR

• HAN XU, MD/PhD/FAPCR

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

  STUDY DIRECTOR

• HAN XU, MD/PhD/FAPCR

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: No-placebo and random and double blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair

Model Details: * The usual approach group * The study approach group

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 21, 2017
• Study Start: August 18, 2023
• Primary Completion (Estimated): May 18, 2026
• Study Completion (Estimated): May 28, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)