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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Abiraterone - Usual
Abiraterone - Study
Sponsored by
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate Cancer focused on measuring Prostate Cancer, PC, SNP, Oncology, Genetics, Pharmacogenomics, CYP

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers
  • Conducting an initial, small, controlled clinical trial to assess for COVID-19 Antigen Presentation Therapeutic Biologics Mix that suggests the potential for clinical benefit of COVID-19 patients.
  • 20 Lower Than Mild COVID-19 Patients

Inclusion Criteria:

  • Lower Than Mild COVID-19 Patients
  • Positive testing COVID-19 by standard RT-PCR assay
  • COVID-19 infection without symptoms
  • Symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste or smell, without shortness of breath or dyspnea
  • No clinical signs indicative of Moderate, Severe, or Critical Severity
  • PPD negative participant is 10 TU skin test reading < 5 mm induration at 48 hours.

Exclusion Criteria:

  • PPD positive participant is 10 TU skin test reading > 5 mm induration at 48 hours
  • Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
  • Clinical signs suggestive of moderate illness with COVID-19
  • Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress
  • Clinical signs indicative of severe systemic illness with COVID-19
  • Evidence of critical illness
  • Respiratory failure
  • Shock
  • Multi-organ dysfunction / failure

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Abiraterone - Usual

Abiraterone - Study

Arm Description

ZYTIGA - Abiraterone Combined Chemotherapy (high dose) ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated Usual Approach Group (high dose)

ZYTIGA - Abiraterone Combined Chemotherapy (low dose) ZYTIGA - abiraterone acetate tablet ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated Usual Approach Group (low dose)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2017
Last Updated
October 12, 2023
Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
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1. Study Identification

Unique Protocol Identification Number
NCT03348670
Brief Title
Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms
Acronym
Drugs-SNPs
Official Title
Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
May 18, 2024 (Anticipated)
Study Completion Date
May 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
Detailed Description
Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind prostate cancer patients. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind prostate cancer patients. Calculate drug target gene SNPs in all 600 recruited double blind prostate cancer patients. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy. Correlate everyone patient drug target gene SNP to everyone patient drug safety. 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). Confirm the relationship between drug target gene SNPs and drug efficacy. Confirm the relationship between drug target gene SNPs and drug safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, PC, SNP, Oncology, Genetics, Pharmacogenomics, CYP

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The usual approach group (high dose) The study approach group (low dose)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
No-placebo and random and double blind
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abiraterone - Usual
Arm Type
Experimental
Arm Description
ZYTIGA - Abiraterone Combined Chemotherapy (high dose) ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated Usual Approach Group (high dose)
Arm Title
Abiraterone - Study
Arm Type
Experimental
Arm Description
ZYTIGA - Abiraterone Combined Chemotherapy (low dose) ZYTIGA - abiraterone acetate tablet ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated Usual Approach Group (low dose)
Intervention Type
Drug
Intervention Name(s)
Abiraterone - Usual
Other Intervention Name(s)
ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated for Oral
Intervention Description
Oral Abiraterone Combined Chemotherapy (high dose)
Intervention Type
Drug
Intervention Name(s)
Abiraterone - Study
Other Intervention Name(s)
ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated for Oral
Intervention Description
Oral Abiraterone Combined Chemotherapy (low dose)
Primary Outcome Measure Information:
Title
Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
Description
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.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate is male organ.
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 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: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HAN XU, MD/PhD/FAPCR
Organizational Affiliation
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
HAN XU, MD/PhD/FAPCR
Organizational Affiliation
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
HAN XU, MD/PhD/FAPCR
Organizational Affiliation
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20853
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://ohrp.cit.nih.gov/search
Description
FWA00015357
URL
http://ohrp.cit.nih.gov/search
Description
IRB00009424
URL
http://ohrp.cit.nih.gov/search
Description
IORG0007849

Learn more about this trial

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

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