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

Prostate Cancer Clinical Trial

— Drugs-SNPs  

Official title:

Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03348670
• Other study ID #: IND 168800 to be IND EXEMPT
• Secondary ID: FWA00015357IRB00
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: August 18, 2023
• Est. completion date: May 28, 2024

Study information

• Verified date: October 2023
• Source: Medicine Invention Design, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: May 28, 2024
• Est. primary completion date: May 18, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 22 Years to 75 Years

Eligibility

• 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 High Dose on ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, 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 Low Dose on ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - 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 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Abiraterone - Usual
Oral Abiraterone Combined Chemotherapy (high dose)
• Abiraterone - Study
Oral Abiraterone Combined Chemotherapy (low dose)

Locations

Country	Name	City	State
United States	Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701	Rockville	Maryland

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 High Dose on ZYTIGA - Abiraterone plus RAYOS - Prednisone plus ORGOVYX - Relugolix to be the usual approach group.; Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy Low Dose on ZYTIGA - Abiraterone plus RAYOS - Prednisone plus ORGOVYX - Relugolix 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

External Links

•   FWA00015357
•   IORG0007849
•   IRB00009424