Ignite Creation Date:
2024-05-06 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05329597
Status:
UNKNOWN
Last Update Posted:
2022-04-15
First Post:
2021-12-21
Brief Title:
Study on Umorestat Hydrogen Sulfate Capsule in Patients With Locally AdvancedMetastatic Pancreatic Cancer
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Study on Pharmacokinetics and Gene Polymorphism of Umorestat Hydrogen Sulfate Capsule in Patients With Locally AdvancedMetastatic Pancreatic Cancer
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Based on the tolerability safety and pharmacokinetics phase III clinical trials of ulimostat hydrochloride capsules LH011 combined with gemcitabine hydrochloride GEM in locally advancedmetastatic pancreatic cancer patients to determine pharmacokinetics the biotransformation pathway and metabolite profile of ulimostat in patients with locally advancedmetastatic pancreatic cancer
Detailed Description:
This study is a research on the pharmacokinetics and gene polymorphisms of ulimostat hydrochloride capsules in patients with locally advancedmetastatic pancreatic cancer Aims to collect the Phase III clinical trials of the tolerability safety and pharmacokinetics of ulimostat capsules LH011 combined with gemcitabine hydrochloride GEM in patients with locally advancedmetastatic pancreatic cancer patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None