CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 387 enrolled
Drug / intervention
Maintenance Chemotherapy +3 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.

Search/NCT01991873
NCT01991873Phase 2Completed

Randomized Phase II Study for Evaluation of Efficacy and Safety of Maintenance Treatment With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction Treatment With mFOLFOX6 Plus Panitumumab and Re-induction With mFOLFOX6 Plus Panitumumab in Case of Progression for First-line Treatment of Patients With Metastatic Colorectal Cancer

AIO-Studien-gGmbH·interventional·Posted Nov 25, 2013·Updated Jun 15, 2023

In Brief

A Phase 2 clinical trial evaluating Maintenance Chemotherapy, Panitumumab (Within maintenance phase), and 2 other interventions for Metastatic Colorectal Cancer. Completed, enrolled 387 participants across 2 sites.

Detailed Summary

This is a phase II, randomized, multi-center, open-label, parallel-group study to evaluate the progression-free survival during maintenance therapy. Eligible patients will be treated within a 12-week induction therapy. Those patients achieving CR/PR or SD at 12 weeks and qualifying for maintenance treatment and re-induction treatment with all potential drug components, will be randomized in a ratio of 1:1 to receive chemotherapy plus panitumumab or chemotherapy alone during maintenance. In case of progression, re-induction treatment will be started.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
CollaboratorsClinAssess GmbH, Amgen

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 25, 2013
Enrollment StartApr 1, 2014
Primary CompletionFeb 18, 2023
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 12.6 years ago

Interventions

Maintenance Chemotherapydrug

Panitumumab (Within maintenance phase)drug

mFOLFOX6 (Within re-induction phase)drug

Panitumumab (Within re-induction phase)drug