Lung Cancer Clinical Trial

Pharmacogenomics IND EXEMPT SNP ANDA Clinical Study – Etoposide and Single Nucleotide Polymorphisms

Summary

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.

View Full Description

Full Description

The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection plus Methotrexate Tablet plus HYCAMTIN - Topotecan 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 Combined Chemotherapy on Etoposide Capsule plus Methotrexate Tablet plus HYCAMTIN - Topotecan 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 total 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.

View Eligibility Criteria

Eligibility Criteria

Select 600 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy
Duration at least 180 days
The usual approach group - Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule after lung tissue biopsy, like as the usual approach group.
The study approach group - Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Capsule plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule after lung tissue biopsy, like as the study approach group.

The 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 22 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. Serious 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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

600

Study ID:

NCT01064466

Recruitment Status:

Active, not recruiting

Sponsor:

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

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There is 1 Location for this study

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Medicine Invention Design, Inc. (MIDI) - IORG0007849
Rockville Maryland, 20853, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

600

Study ID:

NCT01064466

Recruitment Status:

Active, not recruiting

Sponsor:


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

How clear is this clinincal trial information?

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