Advertisement

Topics

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

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

Summary

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.

Description

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

Conditions

Small Cell Lung Cancer

Intervention

ETOPOSIDE INJECTION

Location

Medicine Invention Design Incorporation
Gaithersburg
Maryland
United States
20877

Status

Not yet recruiting

Source

Medicine Invention Design, Inc

Results (where available)

View Results

Links

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

Clinical Trials [5617 Associated Clinical Trials listed on BioPortfolio]

Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin

Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and oth...

Carboplatin and Etoposide in Combination With Vorinostat for Patients With Extensive Stage Small Cell Lung Cancer

The Phase I portion of the study is to assess the maximum tolerated dose of vorinostat when combined with carboplatin plus etoposide. The Phase II portion is to determine progression-free...

Discovery Stage IND EXEMPT Clinical Study - Etoposide Plus Methotrexate and Single Nucleotide Polymorphisms

- Correlate Topoisomerase II Gene Single Nucleotide Polymorphisms (SNPs) to Using Etoposide Therapeutic Effects of Treating Small Cell Lung Cancer (SCLC) - Correlate CYP450 3A4 G...

Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer

This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemet...

Cisplatin and Etoposide With or Without Veliparib in Treating Patients With Extensive Stage Small Cell Lung Cancer or Metastatic Large Cell Neuroendocrine Non-Small Cell Lung Cancer

This randomized phase I/II trial studies the side effects and best dose of veliparib when given together with or without cisplatin and etoposide and to see how well they work in treating p...

PubMed Articles [34291 Associated PubMed Articles listed on BioPortfolio]

Aidi injection plus platinum-based chemotherapy for stage IIIB/IV non-small cell lung cancer: a meta-analysis of 42 RCTs following the PRISMA guidelines.

Aidi injection is one of the most commonly used Chinese patent medicines for advanced non-small cell lung cancer (NSCLC). It is made from an extraction of Mylabris Phalerata, Radix Astragalus, Radix G...

Phase II study of maintenance pembrolizumab in patients with extensive-stage small cell lung cancer (SCLC).

To assess the efficacy of maintenance pembrolizumab in extensive-stage small cell lung cancer (SCLC) patients, after treatment with platinum/etoposide.

Non-Small Cell Lung Cancer - Development of Parallel Mechanisms of Resistance.

Acquired resistances to tyrosine kinase inhibitors in non-small cell lung cancer develop after 9 - 12 month. In 60 % of the cases these resistances arise because of a secondary EGFR-T790 M res...

Comparison of carboplatin plus etoposide with amrubicin monotherapy for extensive-disease small cell lung cancer in the elderly and patients with poor performance status.

Carboplatin plus etoposide (CE) is a standard treatment for elderly patients with extensive-disease small cell lung cancer (ED-SCLC). However, amrubicin monotherapy (AMR) may be a feasible alternative...

Genomic Features of Response to Combination Immunotherapy in Lung Cancer.

In this issue of Cancer Cell, Hellmann et al. describe in two clinical trials the importance of tumor mutational burden as an independent predictive marker for outcomes with combination nivolumab plu...

Medical and Biotech [MESH] Definitions

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.

More From BioPortfolio on "Further Retrospect Clinical Study for FDA IND 78420 Exemption - Etoposide and Single Nucleotide Polymorphisms (SNPs)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

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...

Assays
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. ...


Searches Linking to this Trial