Trial intelligence / Profile preview

VELVET: Aflibercept + OPTIMOX in mCRC

NCT01802684Phase 2

Key facts

Status: Completed
Start: May 2013
Primary completion: Nov 2014
Countries: 1
Sponsor: GERCOR
Modality: Engineered Antibody Formats, Fc-Fusion Proteins

Drugs: aflibercept
Conditions: metastatic colorectal cancer (mCRC)

Overview

Phase 2, open-label, single-arm trial of aflibercept in metastatic colorectal cancer (mCRC), sponsored by GERCOR. Primary endpoint: Progression Free Survival at 6 months. Started May 2013; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

OPTIMOX-aflibercept
Induction with Aflibercept + mFOLFOX7, followed by maintenance with Aflibercept + Fluoropyrimidine, with potential reintroduction of mFOLFOX7 upon progression.

Who it enrols

Patients with histologically proven unresectable metastatic colorectal adenocarcinoma, no prior therapy for metastatic disease, ECOG PS 0-2, and adequate organ function.

Endpoints

Primary

Progression Free Survival at 6 months6 months

Secondary

Median Progression Free Survival3 years
Duration of Disease Control3 years
Overall Survival3 years
Tumor Response Rate16 months
Health related Quality of Life3 years
Safety3 years
Curative salvage surgery3 years

Results

Not all primary endpoints met

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