SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02847377

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Exploratory Phase 0/1 of Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC

The development of biomarkers will lead the dynamic of personalized medicine and fill the unsatisfied needs in oncology for prediction of therapeutic response. Molecular imaging enables non invasive quantification of biomarkers. The development of molecular imaging biomarkers is closely related to the development of therapeutic molecules. Among the potential targets, kinases offer a lot of advantages: (i) they play a central role in cellular regulation, (ii) numerous kinase-specific small molecule libraries exist in biotech and pharma industry, (iii) several kinase-targeted therapies are used in clinic (imatinib, sorafenib, sunitinib…) with application across a variety of therapeutic indications. Among the imaging technologies, the Positron Emission Tomography (PET) is the most sensitive and dedicated to evaluate small molecules. However few radiotracers are available and their specificity limits their clinical use. The IMAkinib® approach is an innovative method proposed to develop new PET radiotracers adapted to current medical and economical challenges. The epidermal growth factor receptor (EGFR) is an established target for the treatment of advanced non-small cell lung cancer (NSCLC). The EGFR tyrosine kinase inhibitors (TKIs) Gefitinib (Iressa®), erlotinib (Tarceva®) and afatinib (Giotrif®) have already been approved for treatment of NSCLC harboring EGFR activating mutations (L858R or del exon 19). Unfortunately the majority of patients will develop a resistance to the TKI in the long term (6-12 months). If the mechanism of resistance is not yet fully characterized, most patients (50%) will acquire an additional T790M mutation of EGFR. TKI PET-imaging can provide a tool to determine and predict responsiveness to EGFR TKI in vivo. That is why, the investigators have selected and radiolabeled (18-Fluor) a compound targeting specifically EGFR mutated ([18F]-ODS2004436) which was further evaluated in a preclinical imaging study to determine the feasibility of TKI-PET. The investigators proved in vivo that [18F]-ODS2004436 a compound is a good candidate to evaluate the EGFR activity in human lung tumours using PET imaging.

NCT02847377 Carcinoma, Non-Small-Cell Lung
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

1 Interventions

Name: Injection of [18F]-ODS2004436 radiotracer

Type: Other

[18F [18F] [18F]-ODS2004436


Primary Outcomes

Description: Sensibility will be evaluated by positron emission tomography (PET) performed on EGFR mutant patient

Measure: Evaluation of sensibility of [18F] ODS2004436

Time: 1 day

Description: Specificity will be evaluated by positron emission tomography (PET) performed on EGFR wild type patient

Measure: Evaluation of specificity of [18F] ODS2004436

Time: 1 day

Other Outcomes

Description: A follow up visit will be performed 3 days after each PET has been performed in order to register adverse events

Measure: Security

Time: 10 days

Purpose: Diagnostic

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

The EGFR tyrosine kinase inhibitors (TKIs) Gefitinib (Iressa®), erlotinib (Tarceva®) and afatinib (Giotrif®) have already been approved for treatment of NSCLC harboring EGFR activating mutations (L858R or del exon 19). --- L858R ---


2 T790M

If the mechanism of resistance is not yet fully characterized, most patients (50%) will acquire an additional T790M mutation of EGFR. --- T790M ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1