Further Retrospect Clinical Study for FDA IND 78420 Exemption - Etoposide and Single Nucleotide Polymorphisms (SNPs)

2014-07-23 21:10:45 | BioPortfolio


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.

Study Design

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
United States


Not yet recruiting


Medicine Invention Design, Inc

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:10:45-0400

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