At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 218 enrolled
Drug / intervention
EndoTAG-1 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating EndoTAG-1 and Gemcitabine for Metastatic Pancreas Cancer and 2 related conditions. Completed, enrolled 218 participants across 68 sites in 7 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Hungary, Israel, Russia, South Korea, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartOct 2018
Primary CompletionJul 2021
Study CompletionOct 2021
TodayJul 2026
First PostedApr 24, 2017
Enrollment StartOct 16, 2018
Primary CompletionJul 30, 2021
Study CompletionOct 8, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.2 years ago
Interventions
EndoTAG-1drug
twice weekly
Gemcitabinedrug
once weekly