Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms
Running, not enrolling · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT03348670
- Run by
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
- People needed
- 600
- Starts
- 2023-08-18
- Expected to finish
- 2026-12-28
- Last updated by the study team
- 2026-06-10
Who can join
Age: 22 and older, up to 75. Sex: male. Healthy volunteers: not accepted.
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
Where it is running
- Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701 — Rockville, Maryland, United States
Full record on ClinicalTrials.gov
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