Gene Polymorphisms, Pancreatic Cancer, Pharmacokinetics
Conditions
Keywords
pharmacokinetics, gene polymorphisms, pancreatic cancer
Brief summary
Based on the tolerability, safety and pharmacokinetics phase I/II clinical trials of ulimostat hydrochloride capsules (LH011) combined with gemcitabine hydrochloride (GEM) in locally advanced/metastatic pancreatic cancer patients, to determine pharmacokinetics, the biotransformation pathway and metabolite profile of ulimostat in patients with locally advanced/metastatic pancreatic cancer.
Detailed description
This study is a research on the pharmacokinetics and gene polymorphisms of ulimostat hydrochloride capsules in patients with locally advanced/metastatic pancreatic cancer. Aims to collect the Phase I/II clinical trials of the tolerability, safety and pharmacokinetics of ulimostat capsules (LH011) combined with gemcitabine hydrochloride (GEM) in patients with locally advanced/metastatic pancreatic cancer patient's peripheral blood sample to determine the structure of the metabolites of ulimostat in the biological samples and trough concentration and genotyping tests were performed on patients to investigate the correlation between gene polymorphisms of metabolic enzymes, transporters, target protein uPA and proteins expressed in upstream and downstream signaling pathways and blood drug concentration, efficacy, safety and tolerance of ulimostat.
Interventions
GENETICGenotyping
Genotyping is performed using the subjects' blood cells
Sponsors
Sun Yat-sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Successfully enrolled in a Phase I/II clinical study on the tolerability, safety and pharmacokinetics of Umorestat hydrogen Sulfate capsule (LH011) combined with gemcitabine hydrochloride (GEM) for patients with locally advanced/metastatic pancreatic cancer. * Fully understand the purpose and requirements of this study and sign a written informed consent. * Willing to provide blood samples.
Exclusion criteria
* Suffering from inflammatory bowel disease. * The researcher considers it unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolite profile | After sampling blood samples (approximately 2 weeks) | Determine the drug metabolite profile: Serum samples were detected by ultra-high pergormance liquid tandem chromatography quadrupole time of flight mass spectrometry(LC-MS). Differential metabolites were screened by principal component analysis(PCA), orthogonal projections to latent structures-discriminant analysis(OPLS-DA) and Student's t-test. Then the hierarchical clustering analysis(HCA) was carried out for the screened differential metabolites. |
| Genotyping | After sampling blood samples (approximately 2 weeks) | To determine the relationship between genotyping and drug exposure, efficacy and safety: Employs PCR to amplify the regions of the genome containing each SNP, then use MassARRAY to detect mass differences between fragments differing by a single base. Use genotyping test results to do correlation analysis with drug concentration, safety results, and efficacy results to determine the relationship between different types of gene locus mutations and drug concentration, efficacy, and adverse reactions. |
Countries
China
Contacts
Primary ContactHerui Yao
Outcome results
None listed