SNPMiner Trials (Home Page)
Report for Mutation C938A
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Phase II Trial of Induction Chemotherapy With ND-420, Cisplatin and Fluorouracil Followed by Surgery in the Treatment of Patients With Localized Squamous Cell Carcinoma of the Esophagus
Investigator will assign 53 patients who had been histologically proven localized squamous cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2 on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every 3 weeks for 2 cycles and then followed by surgical resection. The successful rate of complete treatment per protocol and complete resection will be the primary variant to evaluate in our study.
NCT02017600 Localized Squamous Cell Carcinoma of the Esophagus Drug: ND-420 Procedure: Surgery Drug: Cisplatin Drug: fluorouracil
MeSH:Carcinoma Carcinoma, Squamous Cell Esophageal Neoplasms Esophageal Squamous Cell Carcinoma
HPO:Carcinoma Esophageal neoplasm Squamous cell carcinoma
the correlation between clinical outcomes and the potential predictive genomic biomarkers(B-tubulin mutation, p53-Arg 72Pro, Bcl2-C938A, MDR1-C3435T polymorphism, TNFRSF1B-1466, GSTP1-l105V, CYP1B1, TS-5'UTR) for tumor response. --- C938A ---
Primary Outcomes
Measure: the R0 resection rate of participants Time: up to three monthsSecondary Outcomes
Measure: the response rate (RECIST) of participants Time: up to three monthsMeasure: Number of participants with adverse events as a measure of safety and tolerability Time: up to one year
Measure: the population pharmacokinetic parameters (Cmax, AUC... )of ND-420 in the participants Time: 0, 30min, 1hr of ND-420 infusion. selected randomly form one of 3hr, 7hr, 11hr and 23hr after the end of ND-420 infusion.
Measure: the correlation between clinical outcomes and the potential predictive genomic biomarkers(B-tubulin mutation, p53-Arg 72Pro, Bcl2-C938A, MDR1-C3435T polymorphism, TNFRSF1B-1466, GSTP1-l105V, CYP1B1, TS-5'UTR) for tumor response Time: up to one year
Measure: 1-year survival rate of participants Time: up to one year
Measure: pathologic complete response rate of participants Time: up to one year
Measure: 1-year progression free survival rate of participants Time: up to one year
Measure: 1-year overall survival rate of participants Time: up to one year