Trials / Completed
CompletedNCT03126435
EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX
A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1+GEM vs GEM Alone in Patients With Measurable Locally Advanced/Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 218 (actual)
- Sponsor
- SynCore Biotechnology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 advanced/metastatic 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 and/or metastatic adenocarcinoma of the pancreas eligible for second-line therapy after failing first line therapy with FOLFIRINOX
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EndoTAG-1 | twice weekly |
| DRUG | Gemcitabine | once weekly |
Timeline
- Start date
- 2018-10-16
- Primary completion
- 2021-07-30
- Completion
- 2021-10-08
- First posted
- 2017-04-24
- Last updated
- 2023-05-06
- Results posted
- 2023-03-24
Locations
68 sites across 7 countries: United States, France, Hungary, Israel, Russia, South Korea, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03126435. Inclusion in this directory is not an endorsement.