Trial intelligence / Profile preview

Avastin+Xelox followed by Avastin+Tarceva in mCRC

NCT01135498Phase 2

Key facts

Status: Completed
Start: Nov 2006
Primary completion: Apr 2010
Countries: 1
Sponsor: Roche
Modality: Small Molecules

Drugs: erlotinib
Conditions: metastatic colorectal cancer (mCRC)

Overview

Phase 2, open-label, single-arm trial of erlotinib in metastatic colorectal cancer (mCRC), sponsored by Roche. Primary endpoint: Progression-Free Survival up to 4 years. Started Nov 2006; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Avastin+Xelox -> Avastin+Tarceva
First-line Avastin+Xelox followed by maintenance Avastin+Tarceva

Who it enrols

Adult patients with metastatic adenocarcinoma of the colon or rectum, with at least one measurable lesion, who have not received prior systemic treatment for metastatic disease or prior Avastin/Tarceva.

Endpoints

Primary

Progression-Free Survivalup to 4 years

Secondary

Objective Response Rateup to 4 years
Disease Control Rateup to 4 years
Overall Survivalup to 4 years

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