drugset / Trial / NCT03126435
EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 22 mg/m2 | — |