Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538857
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
CEB-01 in Locally Resectable Pancreatic Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploratory Clinical Trial to Assess Safety Tolerability Efficacy and Pharmacokinetics of CEB-01 PLGA Membrane in Participants with Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The CEB-01 implant is a membrane containing SN-38 the active metabolite of irinotecan an already authorized chemotherapeutic agent After surgical removal of the pancreatic cancer tumor CEB 01 will be placed in the surgical bed for a local and sustained release of the chemotherapy This is expected to delay or prevent local recurrence of pancreatic cancer after surgery while keeping a tolerable toxicity profile
The study aims to assess the safety tolerability pharmacokinetics and efficacy of CEB-01 in patients with locally resectable pancreatic cancer
The study aims to assess the safety tolerability pharmacokinetics and efficacy of CEB-01 in patients with locally resectable pancreatic cancer
Detailed Description:
Exploratory multi-center interventional prospective randomised single-blind controlled clinical trial in adult participants with locally resectable pancreatic cancer Participants will be allocated in a 21 ratio to two treatment arms Arm 1 standard surgery and CEB-01 implant after surgery or Arm 2 standard surgery without implant For measurement of primary safety and efficacy endpoints follow-up will consist of shortterm evaluation at 365 30 days and long-term evaluation at 1095 30 days post-surgery as it is considered sufficient for the assessment of the therapeutic effect of CEB-01 regarding local recurrence For pharmacokinetic assessment blood samples will be collected at baseline and at 8 different time points until 43 7 days post-surgery For each participant the trial duration will be composed by a screening period for of up to 28 days one day for surgery and 1095 30 days of follow-up
The trial population will consist of 21 participants with a de novo pancreatic cancer who fulfil all the inclusion and exclusion criteria
The trial population will consist of 21 participants with a de novo pancreatic cancer who fulfil all the inclusion and exclusion criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None