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Individualized etoposide therapy toward small cell lung cancer (SCLC) with maximizing effectiveness and minimizing risk via assay single nucleotide polymorphisms (SNPs) of relative etoposide targets, topoisomerase II and CYP4503A4.
We got the IND 78,420 Exemption Letter from FDA like as Drug Sponsor on 04/29/2009. In future, any IND is not required to conduct our further relative clinical studies. According to the FDA IND 78,420 Exemption Letter, if anyone Institutional Review Board (IRB) approved our protocol, we can develop our further relative clinical studies. Our Further Retrospect Clinical Study will use Combined Chemotherapy including ETOPOSIDE INJECTION to treat Small Cell Lung Cancer (SCLC) patients and will try to look for the relationships between the ETOPOSIDE INJECTION therapeutic efficacy and the Topoisomerase II SNP Genotyping, and between the ETOPOSIDE INJECTION Adverse Drug Reaction and the CYP4503A4 SNP Genotyping. Whatever any treatment options must include Etoposide Injection, but the cancer patients have had to survive over 2 years. According to Etoposide Injection Directions, the Etoposide target may be Topoisomerase II and the Etoposide metabolism should be relative to CYP4503A4. We hope to discover the Topoisomerase II SNP Genotypes which could be more relative to higher therapeutic efficacies, and the CYP4503A4 SNP Genotypes which could be more relative to lower Adverse Drug Reactions. Because we just only use the SCLC patients' tissue and blood samples to assay the Topoisomerase II SNP Genotypes and the CYP4503A4 SNP Genotypes, so the SCLC patients will be needless to come to NIH or USA.
Allocation: Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Small Cell Lung Cancer
Medicine Invention Design Incorporation
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Medicine Invention Design, Inc
Published on BioPortfolio: 2014-07-23T21:10:45-0400
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- Correlate Topoisomerase II Gene Single Nucleotide Polymorphisms (SNPs) to Using Etoposide Therapeutic Effects of Treating Small Cell Lung Cancer (SCLC) - Correlate CYP450 3A4 G...
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Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.
A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).
A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.
Lung cancer is the uncontrolled cell growth in tissues of the lung. Originating in the lungs, this growth may invade adjacent tissues and infiltrate beyond the lungs. Lung cancer, the most common cause of cancer-related death in men and women, is respons...
An assay is an analytic procedure for qualitatively assessing or quantitatively measuring the presence or amount or the functional activity of a target entity. This can be a drug or biochemical substance or a cell in an organism or organic sample. ...