Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
With
Regeneron Pharmaceuticals
NSABP Foundation Inc
Participants were
* randomized at baseline (treatment was initiated with 3 days of randomization)
* administered treatment in cycles of 14-days till a study withdrawal criterion was met
* followed up 30 days after discontinuation of treatment, and every 8 weeks until death or end of study.
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
* disease progression
* unacceptable AEs
* intercurrent illnesses
* non-compliance to the study protocol
* participant was lost to follow-up
* participant was unblinded for the investigational treatment
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants who met the following main selection criteria were included in the study.
Histologically or cytologically proven adenocarcinoma of the colon or rectum
Metastatic disease that is not amenable to potentially curative treatment
One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible)
Prior treatment with bevacizumab is permitted.
You may not be if
Prior therapy with irinotecan
Eastern Cooperative Oncology Group performance status \>2
The above information is not intended to contain all considerations relevant to participation in a clinical trial.
Clareo Health | Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen