Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513455
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Irinotecan LiposomeAlbumin Paclitaxel and Gemcitabine First-line Treatment for Pancreatic Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Irinotecan Liposome Combined With Albumin Paclitaxel and Gemcitabine as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This is a Phase III Open-label Investigator-initiated Trail of liposomal irinotecannab-paclitaxel and gemcitabine as First-line Treatment in Advanced pancreatic cancer The study was designed in two stages the first stage was the tolerance observation stage and the second stage was the curative effect expansion stage
The first part of the study is the Dose-finding Phase designed to establish the safety of nab-paclitaxelgemcitabine and liposomal irinotecan at different dose Levels40 mgm2 iv q2w or 60 mgm2 iv q2w The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses
This study aims to evaluate the safety and efficacy of liposomal irinotecannab-paclitaxel and gemcitabine in the First-line treatment of advanced pancreatic cancer
The first part of the study is the Dose-finding Phase designed to establish the safety of nab-paclitaxelgemcitabine and liposomal irinotecan at different dose Levels40 mgm2 iv q2w or 60 mgm2 iv q2w The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses
This study aims to evaluate the safety and efficacy of liposomal irinotecannab-paclitaxel and gemcitabine in the First-line treatment of advanced pancreatic cancer
Detailed Description:
The study consists of a dose escalation and expansion phase to determine the recommended Phase 2 dose RP2D for liposomal irinotecan combination with AG and a dose confirmation phase which will further characterize the treatment of liposomal irinotecan in combination at the RP2D
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