Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms (Drugs-SNPs)

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

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Abiraterone - Usual; Drug: Abiraterone - Study

Study type: Interventional

Funder types: Industry

Identifiers

NCT03348670

IRB00009424 (Registry Identifier)

FWA00015357 (Registry Identifier)

IND 178620 Commercial

NPI - 1023387701 (Registry Identifier)

NPI - 1831468511 (Registry Identifier)

IORG0007849 (Registry Identifier)

IND 178620 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Male

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

Abiraterone - Usual

Experimental group

Description:

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

Treatment:

Drug: Abiraterone - Usual

Abiraterone - Study

Experimental group

Description:

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

Treatment:

Drug: Abiraterone - Study