Who is sponsoring NCT01042028?

NCT01042028 is sponsored by Per Pfeiffer.

What condition does NCT01042028 study?

NCT01042028 studies Pancreatic Cancer.

What drugs are being tested in NCT01042028?

Interventions: Everolimus, Cetuximab, Irinotecan, Capecitabine, Oxaliplatine.

What is the status of NCT01042028?

NCT01042028 is currently TERMINATED.

Last reviewed 2015-10-18 · How we verify

A Randomised Fase I/II Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer

NCT01042028 Phase 1/Phase 2 TERMINATED

This is an open multicenter randomized phase I/II study. The main purpose with this study is to investigate dose and efficacy of a combination of Irinotecan, Cetuximab and Everolimus given biweekly to patients with local advanced or metastatic pancreatic cancer AFTER progression from 1. line treatment with Gemcitabine.

Details

Lead sponsor	Per Pfeiffer
Phase	Phase 1/Phase 2
Status	TERMINATED
Enrolment	39
Start date	2010-01
Completion	2014-01

Conditions

Pancreatic Cancer

Interventions

Everolimus, Cetuximab, Irinotecan
Capecitabine, Oxaliplatine

Primary outcomes

Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus) — 4 months
Phase I: Determine the maximum tolerated dose (MTD) of ICE in patients with gemcitabine resistant pancreatic cancer — 4 months
Phase II: Progression-free survival as measured from inclusion to either documentation of disease progression or death — 18 months

Countries

Denmark