CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 141 enrolled
Drug / intervention
Drug: Everolimus +1 moredrug
Likely dose
Drug: Everolimus 10mgfrom 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.

Search/NCT02246127
NCT02246127Phase 3Completed
CompareCT.gov

Randomized Open Label Study to Compare the Efficacy and Safety of Everolimus Followed by Chemotherapy With Streptozotocin- Fluorouracilo (STZ-5FU) Upon Progression or the Reverse Sequence, in Advanced Progressive Pancreatic NETs (pNETs)

Grupo Espanol de Tumores Neuroendocrinos·interventional·Posted Sep 22, 2014·Updated May 11, 2025

In Brief

A Phase 3 clinical trial evaluating Drug: Everolimus and STZ-5FU for Neuroendocrine Tumors. Completed, enrolled 141 participants across 37 sites in 8 countries.

Detailed Summary

The purpose of this study is to compare streptozotocin (STZ) vs everolimus as first line treatment for advanced pNET and to elucidate which sequence of STZ based chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms of second Progression Free Survival (PFS) in well differentiated and advanced pancreatic NETs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroendocrine Tumors
CountriesDenmark, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
CollaboratorsEuropean Neuroendocrine Tumor Society, Kantar Health, Novartis Pharmaceuticals

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 22, 2014
Enrollment StartOct 27, 2014
Primary CompletionNov 18, 2020
Study CompletionJul 12, 2021
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 11.8 years ago

Interventions

Drug: Everolimusdrug

10mg/daily, oral. Number of Cycles: until progression or unacceptable toxicity develops.

STZ-5FUdrug

0,5g/m2 STZ on days 1-5 and 400mg/m2 5-FU on days 1-5 every 6 weeks (Moertel) or 0,5g/m2 STZ on days 1-5 and 400mg/m2 5-FU on days 1-3, and then 1 day with 1g/m2 and 1 day 400mg/m2 5-FU every 3 weeks (Uppsala). Number of Cycles: until progression or unacceptable toxicity develops.