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A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and / or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment

Status
Active
Cancer Type
Pancreatic Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03126435
Protocol IDs
CT4006 (primary)
NCI-2018-03490
Study Sponsor
SynCore Biotechnology Co., Ltd.

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.
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