Pharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms

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

Sponsor score: 0

ClinicalTrials ID:NCT01064466

This clinical trial investigates the link between SNPs in Topoisomerase II and CYP4503A4 genes and Etoposide's efficacy and safety in 600 SCLC patients. Participants, aged 24+, undergo lung biopsies and are randomly assigned to receive either standard or China-imported Etoposide capsules. The study involves precise gene sequencing and SNP analysis to correlate genetic variations with treatment outcomes.

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Program Overview

Explore the relationship between drug target topoisomerase II gene single nucleotide polymorphisms and Etoposide (VP-16) therapeutic-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and Etoposide (VP-16) side-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Description

The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Chemotherapy on ETOPOSIDE capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

The study approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Etoposide Capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

1) Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind SCLC patients.
2) Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind SCLC patients.
3) Calculate drug target gene SNPs in all 600 recruited double blind SCLC 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 SCLC patients) with the study approach group SNPs (300 double blind random group separated SCLC 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.

Eligibility Criteria

Inclusion Criteria

1. Clinical diagnosis of Small Cell Lung Cancer (SCLC)
2. Clinical lung tissue biopsy diagnosis of SCLC
3. Suitable for enough lung tissue biopsy of SCLC
4. Random and double blind
5. Measurable disease
6. Adequate organ functions
7. Adequate performance status
8. Age 24 years old and over
9. Sign an informed consent form
10. Receive blood-drawing

The

Exclusion Criteria

1. Pneumonectomy
2. Treatment with other anti-cancer therapies and cannot be stopped currently
3. Pregnancy
4. Breast-feeding
5. The patients with other serious intercurrent illness or infectious diseases
6. Have more than one different kind of cancer at the same time
7. Serious Allergy to Drugs
8. Clot or Bleed Tendency
9. Serious Risks or Serious Adverse Events of the drug product
10. The prohibition of drug products
11. Have no therapeutic effects
12. Follow up to the most current label

Locations

FACILITY	ZIP	CITY	STATE
Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701	20853	Rockville	Maryland

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