drugset / Trial / NCT03126435

EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX

NCT03126435 ↗

Phase 3 Completed 218 enrolled SynCore Biotechnology Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-10-16
Primary completion
2021-07-30
Completion
2021-10-08

Outcome

Missed primary endpoint

registry analysis (superiority test); EndoTAG-1 and Gemcitabine vs Gemcitabine Monotherapy; p = 0.6647; Log Rank NCT03126435 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 —
Subject Paclitaxel Small molecule 22 mg/m2 —