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Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen

NCT01571284 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 781

Last updated 2018-04-17

Study results available
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Summary

Primary Objective:

To provide metastatic colorectal cancer participants with access to aflibercept and to document the overall safety in these participants

Secondary Objective:

To document the Health-Related Quality of Life of aflibercept in this participants population

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

AFLIBERCEPT AVE0005

Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous

DRUG

FOLFIRI

irinotecan, 5-FU and leucovorin

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-30
Primary Completion
2017-01-31
Completion
2017-01-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Ireland
  • Israel
  • Italy
  • Lebanon
  • Mexico
  • Netherlands
  • Norway
  • Puerto Rico
  • Russia
  • Spain
  • Sweden
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01571284 on ClinicalTrials.gov