Viewing Study NCT03126435



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Last Modification Date: 2024-10-26 @ 12:22 PM
Study NCT ID: NCT03126435
Status: COMPLETED
Last Update Posted: 2023-05-06
First Post: 2017-04-19

Brief Title: EndoTAG-1GEM vs GEM in Patients With Locally AdvancedMetastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX
Sponsor: SynCore Biotechnology Co Ltd
Organization: SynCore Biotechnology Co Ltd

Study Overview

Official Title: A Randomized Controlled Open Label Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1GEM vs GEM Alone in Patients With Measurable Locally AdvancedMetastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment
Status: COMPLETED
Status Verified Date: 2023-05
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 aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advancedmetastatic pancreatic cancer after FOLFIRINOX failure
Detailed Description: The objective of the study was to assess the safety and efficacy of a combination therapy of EndoTAG-1 plus gemcitabine vs gemcitabine monotherapy in patients with locally advanced andor metastatic adenocarcinoma of the pancreas eligible for second-line therapy after failing first line therapy with FOLFIRINOX

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