The purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line therapy with gemcitabine. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or capecitabine. Treatment will be continued for as long as the patients receive clinical benefit. The status of all patients will be checked (whether they are still taking treatment or not) approximately 3 months after the last patient has entered the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
oral capsule
oral tablet
Research Site
Alhambra, California, United States
Research Site
Bakersfield, California, United States
Research Site
Palm Springs, California, United States
Research Site
Santa Maria, California, United States
Research Site
Orlando, Florida, United States
Research Site
Chevy Chase, Maryland, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
New York, New York, United States
Research Site
Nashville, Tennessee, United States
Research Site
Temple, Texas, United States
...and 7 more locations
Median time to death (TTD)
The TTD (days) was calculated as the interval from date of randomisation to date of patient death (from any cause). Patients who had not died at the time of the final analysis were censored at the last date the patient was known to be alive. Median TTD in days is presented here.
Time frame: Data cut off for this analysis was 5th April 2008.
Progression event count
The number of patients with a progression event occurring on or before MTAV where an event is defined as Objective and/or clinical disease progression as measured using RECIST criteria, or death from any cause
Time frame: The mandatory tumour assessment visit (MTAV) occurred on 27th February 2008 (+/-3days)
To assess the safety and tolerability of AZD6244 in the treatment of advanced or metastatic pancreatic cancer by review of adverse events (AEs) and laboratory parameters.
Time frame: Review of AEs for duration of study, from First Subject in August 2006 to Last Subject Last visit October 2008
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