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

Last updated: October 12, 2023
Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Covid-19

Prostate Cancer

Prostate Cancer, Early, Recurrent

Treatment

Abiraterone - Usual

Abiraterone - Study

Clinical Study ID

NCT03348670
IND 168800 to be IND EXEMPT
IND167005
IND 168800
IND166012
NPI - 1831468511
IRB00009424
FWA00015357
NPI - 1023387701
IORG0007849
  • Ages 22-75
  • Male

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 RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, 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 ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, 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 Criteria

Inclusion

  • 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 prostatecancer patients currently used the Combined Chemotherapy High Dose on ZYTIGA -abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayedrelease plus ORGOVYX - relugolix tablet, film coated, like as the usual approachgroup.
  • The study approach group - Recruit 300 double blind random group separated prostatecancer patients currently used the Combined Chemotherapy Low Dose on ZYTIGA -abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plusORGOVYX - relugolix tablet, film coated, 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

Exclusion Criteria:

  1. Treatment with other anti-cancer therapies and the therapies cannot be stoppedcurrently
  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

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Abiraterone - Usual
Phase: 2/3
Study Start date:
August 18, 2023
Estimated Completion Date:
May 28, 2024

Study Description

  1. Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind prostate cancer patients.

  2. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind prostate cancer patients.

  3. Calculate drug target gene SNPs in all 600 recruited double blind prostate cancer patients.

  4. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.

  5. Correlate everyone patient drug target gene SNP to everyone patient drug safety.

  6. Mutually compare the usual approach group SNPs (300 double blind random group separated prostate cancer patients) with the study approach group SNPs (300 double blind random group separated prostate cancer patients).

  7. Confirm the relationship between drug target gene SNPs and drug efficacy.

  8. Confirm the relationship between drug target gene SNPs and drug safety.

Connect with a study center

  • Medicine Invention Design, Inc. (MIDI) - c/o - MIDINC Clinical Investigator Working Site

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • Medicine Invention Design, Inc. (MIDI) - c/o - MIDINC Clinical Investigator Working Site

    North Bethesda, Maryland 20852
    United States

    Site Not Available

  • MIDI Clinical Trial Sites -c/o- Dr. Han Xu - Sponsor / Investigators / Physicians / Laboratories Operation Site

    Rockville, Maryland 20853
    United States

    Site Not Available

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

    Rockville, Maryland 20853
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.