Trials / Completed
CompletedNCT01571284
Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen
A Multicenter, Single Arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients With Metastatic Colorectal Cancer (mCRC) Previously Treated With an Oxaliplatin-Containing Regimen
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 781 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
Each participants will be treated until disease progression, unacceptable toxicity, death, Investigator's decision or participant's refusal for further treatment (whichever comes first). Participants were followed-up during study treatment and for at least 30 days after last administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AFLIBERCEPT AVE0005 | Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous |
| DRUG | FOLFIRI | irinotecan, 5-FU and leucovorin |
Timeline
- Start date
- 2012-05-30
- Primary completion
- 2017-01-31
- Completion
- 2017-01-31
- First posted
- 2012-04-05
- Last updated
- 2018-04-17
- Results posted
- 2018-02-27
Locations
179 sites across 23 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01571284. Inclusion in this directory is not an endorsement.