Ignite Creation Date:
2024-05-06 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05355298
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2022-04-07
Brief Title:
ACCENT AMP945 in Combination With Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer
Sponsor:
Amplia Therapeutics Limited
Organization:
Amplia Therapeutics Limited
Study Overview
Official Title:
A Phase 1b2a Multicentre Open Label Study of the Pharmacokinetics Safety and Efficacy of AMP945 in Combination With Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-03
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 is a multicentre open label two-part study to determine whether the focal adhesion kinase FAK inhibitor AMP945 when given prior to dosing with gemcitabine and nab-paclitaxel improves response to therapy in first-line patients with unresectable or metastatic pancreatic cancer
Part A is a phase 1b dose-escalation design that will enrol at least 3 participants in each of 4 dose-level cohorts to determine the RP2D of AMP945 to be explored in Part B
Part B will determine the efficacy of the AMP945 regimen at the RP2D and will be run as a Simon Two-stage design Stage 1 will enrol 26 participants If 5 of the 26 participants show an objective response then recruitment will be paused and a detailed analysis of futility will be performed If the study is deemed futile recruitment will cease If the study is determined to be not futile or 5 of the 26 participants show an objective response recruitment will continue and an additional 24 participants will be enrolled in Stage 2
Part A is a phase 1b dose-escalation design that will enrol at least 3 participants in each of 4 dose-level cohorts to determine the RP2D of AMP945 to be explored in Part B
Part B will determine the efficacy of the AMP945 regimen at the RP2D and will be run as a Simon Two-stage design Stage 1 will enrol 26 participants If 5 of the 26 participants show an objective response then recruitment will be paused and a detailed analysis of futility will be performed If the study is deemed futile recruitment will cease If the study is determined to be not futile or 5 of the 26 participants show an objective response recruitment will continue and an additional 24 participants will be enrolled in Stage 2
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