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

• Find Etoposide Drug Targets' SNP Genotypes which are relative to maximizing effectiveness and which are relative to minimizing risk. [ Time Frame: Duration at least 180 days ] [ Designated as safety issue: Yes ]
  1. Recruit 400 selected specific SCLC patients who are still surviving currently after at least 2 years used the Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION.
  2. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (Topoisomerase II) SNP genotype in his or her SCLC cell whole genome DNA with precisely sequencing.
  3. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with precisely sequencing.
  
  

Targeted SCLC chemotherapy with VP-16 and personalized patient-specific biomarkers (SNPs)

We obtained 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. // We obtained the NCI Investigator ID 49256 from NCI like as Clinical Investigator on 01/08/2012. // We obtained DHHS and IRB approval document: Federal-wide Assurance (FWA) for the Protection of Human Subjects for Institutions within the United States (FWA: 00015357). So we can develop our further relative clinical studies in USA.

Our Further Retrospect Clinical Study will use Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION to treat Small Cell Lung Cancer (SCLC) patients, and will try to look for the relationship between the ETOPOSIDE INJECTION therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE INJECTION Adverse Drug Reaction and the CYP4503A4 SNP Genotyping, based on precisely sequencing drug targets' genes.

The treatment option must be ETOPOSIDE INJECTION plus CISPLATIN INJECTION, but the the specific SCLC patients, who had used the ETOPOSIDE INJECTION plus CISPLATIN INJECTION until right now, have had to survive over 2 years.

According to Etoposide Injection Directions, the Etoposide efficacy target may be Topoisomerase II and the Etoposide metabolism target 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.

We will assay Single Nucleotide Polymorphisms (SNPs) of Etoposide (VP-16) drug target (Topoisomerase II) which are relative to maximizing effectiveness, and will assay Single Nucleotide Polymorphisms (SNPs) of Etoposide (VP-16) drug target (CYP4503A4) which are relative to minimizing risk in the specific SCLC patients who are surviving after 2 years used Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION, based on precisely sequencing drug targets' genes.

In the Retrospect Stage, every patient's Combined Chemotherapy Plan must use the same Oncology Drugs' Combination - ETOPOSIDE INJECTION plus CISPLATIN INJECTION as the patient used at all times since 2 years ago until right now. // In the Retrospect Stage, all of SCLC patients msut be used the same Combined Chemotherapy Plan or Oncology Drugs' Combination - ETOPOSIDE INJECTION plus CISPLATIN INJECTION. // In the Retrospect Stage, the Combined Chemotherapy Plan or Oncology Drugs' Combination must the ETOPOSIDE INJECTION plus CISPLATIN INJECTION. // All of oncology drugs must be approved by USA FDA and must be sold on USA market legally. // The dosages about all of oncology drugs must abide by their labeling in USA. // All of Adverse Drug Reactions for all of oncology drugs in our clinical studies must be provided most suitable and professional symptomatic treatments.

We need use the SCLC patients' tissue or humoral specimens to assay the Topoisomerase II SNP Genotypes and the CYP4503A4 SNP Genotypes with precisely sequencing drug targets' genes in USA.