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
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
The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease.
The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.
Participants were
The criteria for discontinuation of study treatment for a participant are:
participant (or legal representative) chose to withdraw from treatment
the investigator thought that continuation of the study would be detrimental to the participants well-being due to
participant was lost to follow-up
participant was unblinded for the investigational treatment
Participants who met the following main selection criteria were included in the study.
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to participation in a clinical trial.
Hot Springs, Arizona 71913, United States
South San Francisco, California 94080, United States
Hendersonville, North Carolina 28791, United States
Ciudad de Buenos Aires, C1426BOR, Argentina
Clichy Cx, 92118, France
Ilion, Athens, Greece
Sittard-Geleen, 6162 BG, Netherlands