Discovery Stage Clinical Study About Oncology Drugs and Single Nucleotide Polymorphisms
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 22 - 75 |
| Updated: | 1/18/2019 |
| Start Date: | December 2, 2018 |
| End Date: | August 2020 |
Discover the Relationship Between the Oncology Drug Therapeutic Efficacy and the Relative Drug Target SNP Genotyping, and the Relationship Between the Oncology Drug Therapeutic Safety and the Relative Drug Target SNP Genotyping.
That current oncology drugs on USA market have the universal problems about low effectiveness
of pharmacology to cancer cells and high risk of toxicology to normal cells can demonstrate
following most significantly and most reasonably: it is not enough so far away that just only
oncology drug target molecules as cancer patient-specific biomarkers directly; it must be
that oncology drug targets' SNPs like as real personalized or individualized cancer
patient-specific biomarkers.
of pharmacology to cancer cells and high risk of toxicology to normal cells can demonstrate
following most significantly and most reasonably: it is not enough so far away that just only
oncology drug target molecules as cancer patient-specific biomarkers directly; it must be
that oncology drug targets' SNPs like as real personalized or individualized cancer
patient-specific biomarkers.
In the Sponsor-Investigator's discovery human subjects' study, the investigators will use the
ABIRATERONE plus PREDNISONE plus ENZALUTAMIDE (300 patients - Group 1) or the ABIRATERONE
plus PREDNISONE plus NILANDRON (300 patients - Group 2) to treat Prostate Cancer patients and
will try to look for the relationship between the ABIRATERONE ACETATE TABLET therapeutic
efficacy and the drug target CYP17 SNP Genotyping, and the relationship between the
ABIRATERONE ACETATE TABLET therapeutic safety and the drug target CYP1A2, CYP2C8, CYP2C9,
CYP2C19, CYP2D6, CYP3A4/5, CYP17 and SULT2A1 SNP Genotyping.
According to ABIRATERONE ACETATE TABLET Labeling Directions, the ABIRATERONE drug target
CYP17 should be effectiveness-associated; and the ABIRATERONE drug target CYP1A2, CYP2C8,
CYP2C9, CYP2C19, CYP2D6, CYP3A4/5, CYP17 and SULT2A1 should also be risk-associated. The
investigators hope to discover the CYP17 SNP Genotypes which may be effectiveness-associated,
and the CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4/5, CYP17 and SULT2A1 SNP Genotypes
which may be risk-associated.
- 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 total
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 (Group -1 -- 300 double blind random
group separated prostate cancer patients) with the study approach group SNPs (Group - 2
-- 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.
ABIRATERONE plus PREDNISONE plus ENZALUTAMIDE (300 patients - Group 1) or the ABIRATERONE
plus PREDNISONE plus NILANDRON (300 patients - Group 2) to treat Prostate Cancer patients and
will try to look for the relationship between the ABIRATERONE ACETATE TABLET therapeutic
efficacy and the drug target CYP17 SNP Genotyping, and the relationship between the
ABIRATERONE ACETATE TABLET therapeutic safety and the drug target CYP1A2, CYP2C8, CYP2C9,
CYP2C19, CYP2D6, CYP3A4/5, CYP17 and SULT2A1 SNP Genotyping.
According to ABIRATERONE ACETATE TABLET Labeling Directions, the ABIRATERONE drug target
CYP17 should be effectiveness-associated; and the ABIRATERONE drug target CYP1A2, CYP2C8,
CYP2C9, CYP2C19, CYP2D6, CYP3A4/5, CYP17 and SULT2A1 should also be risk-associated. The
investigators hope to discover the CYP17 SNP Genotypes which may be effectiveness-associated,
and the CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4/5, CYP17 and SULT2A1 SNP Genotypes
which may be risk-associated.
- 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 total
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 (Group -1 -- 300 double blind random
group separated prostate cancer patients) with the study approach group SNPs (Group - 2
-- 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.
Inclusion Criteria:
- Clinical diagnosis of prostate cancer
- Clinical biopsy diagnosis of prostate cancer
- Suitable for local therapy with surgery
- Random and double blind
- Measurable disease
- Adequate organ functions
- Adequate performance status
- Age 22 years old and over
- Sign an informed consent form
Exclusion Criteria:
- Treatment with other anti-cancer therapies and cannot be stopped currently
- Pregnancy
- Breast-feeding
- The patients with other serious inter-current illness or infectious diseases
- Have more than one different kind of cancer in the same time
- Allergy to drugs
- Serious Bleed Tendency
- Serious Risks or Serious Adverse Events of the drug product
- The prohibition of the drug product
- Up to most current label
We found this trial at
2
sites
Gaithersburg, Maryland 20877
Principal Investigator: Han Xu, M.D. / Ph.D.
Phone: 301-222-7143
Click here to add this to my saved trials
Gaithersburg, Maryland 20877
Principal Investigator: HAN XU, M.D., Ph.D.
Phone: 301-222-7143
Click here to add this to my saved trials