A Multicenter, Randomised, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (FOLFIRI) As First Line Treatment
On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of
Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria
and was unlikely to meet its primary endpoint to demonstrate a statistically significant
improvement in progression-free survival (PFS) in patients treated with sunitinib plus
FOLFIRI versus placebo plus FOLFIRI. No new safety findings were noted. Pfizer notified
clinical trial investigators involved in the study and regulatory agencies of these
findings. Patients receiving benefit on treatment as determined by the investigator may
remain on study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression-free Survival (PFS)
PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.
First dose of study treatment up to 30 months
Pfizer CT.gov Call Center
United States: Food and Drug Administration