Ignite Creation Date:
2024-05-06 @ 2:38 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04381130
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2020-05-07
Brief Title:
A Phase IIIa Study of EF-009 in Patients With Pancreatic Cancer
Sponsor:
Everfront Biotech Co Ltd
Organization:
Everfront Biotech Co Ltd
Study Overview
Official Title:
A Phase IIIa Study to Determine the Maximum Tolerated Dose MTD and to Evaluate the Safety and Efficacy Profile of EF-009 in Patients With Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
This study is a multi center open-label dose escalation Phase IIIa study of EF-009 in up to 30 patients with borderline resectable and unresectable pancreatic cancer
Detailed Description:
In Phase I the study will follow a 33 design to determine the maximum tolerated dose MTD of EF-009 implanted surgically in patients with pancreatic cancer The MTD is defined as one dose level cohort below the dose in which dose limiting toxicities DLTs were observed in 33 of the participants
Phase IIa is a single arm study with up to 12 subjects in order to test the hypothesis that the MTD of EF-009 will increase the overall survival OS and progression free survival PFS in patients with borderline resectable and unresectable pancreatic cancer The number of EF-009 implanted will be based on the MTD dose determined in the Phase I portion of the study
In both the Phase I and Phase IIa portions of the study subjects will be evaluated for response every 8 weeks after EF-009 wafer implantation for up to 2 years by CT PETCT or MRI per treating investigators discretion using the same method as at baseline Tumor measurements will be assessed based on the Response Evaluation Criteria in Solid Tumors guidelines version 11 RECIST v11 The total study duration for each subject consists of screening treatment and extended follow-up period and survival follow-up period
Phase IIa is a single arm study with up to 12 subjects in order to test the hypothesis that the MTD of EF-009 will increase the overall survival OS and progression free survival PFS in patients with borderline resectable and unresectable pancreatic cancer The number of EF-009 implanted will be based on the MTD dose determined in the Phase I portion of the study
In both the Phase I and Phase IIa portions of the study subjects will be evaluated for response every 8 weeks after EF-009 wafer implantation for up to 2 years by CT PETCT or MRI per treating investigators discretion using the same method as at baseline Tumor measurements will be assessed based on the Response Evaluation Criteria in Solid Tumors guidelines version 11 RECIST v11 The total study duration for each subject consists of screening treatment and extended follow-up period and survival follow-up period
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?:
None
Is an FDA AA801 Violation?:
None