Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492915
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-27
Brief Title:
Chiauranib in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Sponsor:
Chipscreen Biosciences Ltd
Organization:
Chipscreen Biosciences Ltd
Study Overview
Official Title:
A Phase Ⅱ Study of Chiauranib Plus Albumin-paclitaxel and Gemcitabine as First-line Therapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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:
Chiauranib which simultaneously targets against VEGFRAurora BCSF-1R several key kinases involved in tumor angiogenesis tumor cell mitosis and chronic inflammatory microenvironment
Detailed Description:
Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases VEGFR2 VEGFR1 VEGFR3 PDGFRa and c-Kit mitosis-related kinase Aurora B and chronic inflammationrelated kinase CSF-1R in a high potency manner with the IC50 at a single-digit nanomolar range In particular Chiauranib showed very high selectivity in the kinase inhibition profile with little activity on off-target non-receptor kinases proteins GPCR and ion channels indicative of a better drug safety profile in terms of clinical relevance
This study is a phase II single arm open label multi-center study to evaluate the efficacy and safety of chiauranib plus albumin-paclitaxel and gemcitabine as first-line therapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma
This study is a phase II single arm open label multi-center study to evaluate the efficacy and safety of chiauranib plus albumin-paclitaxel and gemcitabine as first-line therapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma
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