Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in theTreatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen (VELOUR)
Tracking Information
Start Date ICMJE | November 2007 |
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Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: August 21, 2008) | Overall Survival [ Time Frame: Study period ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: November 20, 2007) | Overall Survival |
Change History | Complete list of historical versions of study NCT00561470 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: August 21, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: November 20, 2007) |
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Descriptive Information
Brief Title ICMJE | Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in theTreatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen |
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Official Title ICMJE | A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen |
Brief Summary | The main objective of the study is evaluate the effectiveness of aflibercept in increasing the overall survival in patients with metastatic colorectal cancer treated with irinotecan and 5-FU and that have previously failed an oxaliplatin based treatment for metastatic disease. Secondary objectives include response to treatment, progression free survival, safety, documentation of potential immunogenicity of aflibercept and, in selected centers the pharmacokinetics of aflibercept. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1200 | ||||
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Estimated Completion Date | December 2010 | ||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | ||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Austria, Belgium, Brazil, Chile, Czech Republic, Denmark, Estonia, France, Germany, Greece, Italy, Korea, Republic of, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00561470 | ||||
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Responsible Party | ICD Study Director, sanofi-aventis | ||||
Study ID Numbers ICMJE | EFC10262, EudraCT 2007-000820-42 | ||||
Study Sponsor ICMJE | Sanofi-Aventis | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | Sanofi-Aventis |
Source: http://clinicaltrials.gov/