Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862260
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2021-04-06
Brief Title:
Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma
Sponsor:
CHU de Quebec-Universite Laval
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
A Phase 1 Feasibility Study of Cholesterol Metabolism Reprogramming Evolocumab Atorvastatin and Ezetimibe in Combination With the Standard of Care in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
Cardiovascular diseases and cancers the two leading causes of death in Canada require cholesterol to sustain their progression All cells require cholesterol but cancer cells have much higher needs to sustain growth division and metastasis The availability of new cholesterol-lowering drugs developed to protect patients from heart diseases has resulted in unprecedented low levels of cholesterol The combination of atorvastatin ezetimibe and Repatha which are 3 cholesterol-lowering drugs used in combination is safe well tolerated and efficient over years of treatment Recent reports indicate that abundant cholesterol supplies are required to sustain the progression of pancreatic ductal adenocarcinomas This proof-of-concept study aims to verify the feasibility the acceptability and gain preliminary data on adding a cholesterol shortage on top of FOLFIRINOX standard chemotherapy in newly diagnosed patients with locally advanced pancreatic adenocarcinomas or metastatic pancreatic adenocarcinomas It is expected that a drug-induced cholesterol shortage will slow-down or stop the progression of pancreatic adenocarcinomas while increasing the response to chemotherapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None